ID

28016

Description

Double blind, randomised, prospective placebo controlled parallel group phase III study to investigate the effect of EGCG supplementation on disease progression of patients with Multiple System Atrophy (MSA) NCT02008721 Short title: Progression Rate of MSA under EGCG Supplementation as anti-Aggregation-Approach Study Code: PROMESA EudraCT-Number: 2012-000928-18 NCT02008721 Sponsor: Klinikum Großhadern Medical Center University of Munich,Represented by the Medical Director Prof. Dr. med. Burkhard Göke, Marchioninistraße 15 D-81377 Munich Principal Investigator: Prof. Dr. med. Günter Höglinger Department of Neurology, Klinikum rechts der Isar Technische Universität München Ismaninger Str. 22 D-81675 Munich; Contact: Yvonne Rödenbeck Trial Monitoring: Münchner Studienzentrum Klinikum rechts der Isar ,Technische Universität München, Ismaninger Str.22 D-81675 Munich Trial Monitoring: Prof. Dr. rer. nat. Ulrich Masnmann, Institute for Medical Informatics, Biometry and Epidemiology (IBE), Marchioninistraße 15 D-81377 Munich Trial Office: Deutsches Zentrum für Neurodegenerative Erkrankungen e.V., Max-Lebsche Platz 30, D-81377 Munich Source: Priv.-Doz. Dr. med. Johannes Levin Neurologische Klinik Ludwig-Maximilians-Universität München

Keywords

Versions (1)
  1. 12/10/17 12/10/17 -
Copyright Holder

Priv.-Doz. Dr. med. Johannes Levin

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December 10, 2017

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License

Creative Commons BY-NC 3.0
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PROMESA NCT02008721

English

Screening Visit (V0)

1 forms  
  1. StudyEvent: ODM
    1. Screening Visit (V0)
Screening Visit
Description

Screening Visit

Alias
UMLS CUI-1
C2097637
Date of visit
Description

Date of screening

Data type

date

Alias
UMLS CUI [1,1]
C1710477
UMLS CUI [1,2]
C0011008
Informed consent
Description

Informed consent

Alias
UMLS CUI-1
C0021430
The patient has been thoroughly informed about all purposes and risks pertinent to the study
Description

Informed consent

Data type

integer

Alias
UMLS CUI [1]
C0021430
The patient has been thoroughly informed about all purposes and risks pertinent to the study
Description

Informed consent

Data type

integer

Alias
UMLS CUI [1]
C0021430
Date
Description

Date of informed consent

Data type

date

Alias
UMLS CUI [1]
C2985782
Name (MD)
Description

Name MD

Data type

text

Alias
UMLS CUI [1,1]
C1710470
UMLS CUI [1,2]
C0600091
Signature (MD)
Description

SIgnature investigator

Data type

text

Alias
UMLS CUI [1]
C2346576
Date of written informed consent
Description

Date informed consent

Data type

date

Alias
UMLS CUI [1]
C2985782
Demographic Data
Description

Demographic Data

Alias
UMLS CUI-1
C0011298
Gender
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Birth date
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Age at screening
Description

Patient age

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1]
C0001779
years
Medical history
Description

Medical history

Alias
UMLS CUI-1
C0262926
relevant medical history
Description

relevant medical history

Data type

integer

Alias
UMLS CUI [1]
C0262926
Medical History
Description

Medical History

Alias
UMLS CUI-1
C0262926
Body system
Description

Body system

Data type

integer

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0460002
Disease/Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Start of disease or surgery
Description

Start of disease or surgery

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0808070
UMLS CUI [2]
C1628561
Not known
Description

Start Date not known

Data type

boolean

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0439673
End of disease or surgery
Description

End of disease or surgery

Data type

date

Alias
UMLS CUI [1]
C4019088
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0444930
Not known
Description

End date unknown

Data type

boolean

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0439673
Persistent
Description

Disease persistent

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205322
MSA History
Description

MSA History

Alias
UMLS CUI-1
C0393571
UMLS CUI-2
C0262926
Onset of first symptoms
Description

Onset of first symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0277793
Not known
Description

Onset of first symptoms not known

Data type

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0277793
UMLS CUI [1,3]
C0439673
Date of first MSA diagnosis
Description

MSA diagnosis date

Data type

date

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C2316983
Not known
Description

MSA Diagnosis date not known

Data type

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C2316983
UMLS CUI [1,3]
C0439673
First symptoms
Description

MSA Type of first symptoms

Data type

integer

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C1457887
Syncope
Description

MSA syncope

Data type

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0039070
Orthostatic hypotension
Description

MSA Orthostatic hypotension

Data type

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0020651
Urinary Incontinence
Description

MSA Urinary Incontinence

Data type

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0042024
Erectile Dysfuntion
Description

MSA Erectile Dysfuntion

Data type

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C2733447
Other (please specify)
Description

MSA Other autonomic symptoms

Data type

text

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C2674101
UMLS CUI [1,3]
C1521902
Bradykinesia
Description

MSA Bradykinesia

Data type

boolean

Alias
UMLS CUI [1,1]
C2733447
UMLS CUI [1,2]
C3176307
Rigidity
Description

MSA Rigidity

Data type

boolean

Alias
UMLS CUI [1,1]
C2733447
UMLS CUI [1,2]
C0858572
Tremor
Description

MSA Tremor

Data type

boolean

Alias
UMLS CUI [1,1]
C2733447
UMLS CUI [1,2]
C0040822
Resting tremor
Description

Only answer, if answer to previous question was 'yes'.

Data type

boolean

Alias
UMLS CUI [1]
C0234379
Postural tremor
Description

Only answer, if answer to previous question was 'yes'.

Data type

boolean

Alias
UMLS CUI [1]
C0234378
other (please specify)
Description

MSA Other parkinsonism symptoms

Data type

text

Alias
UMLS CUI [1,1]
C2733447
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1521902
Onset of falls
Description

Onset of falls

Data type

date

Alias
UMLS CUI [1,1]
C0085639
UMLS CUI [1,2]
C0574845
Current frequency of falls
Description

frequency of falls

Data type

integer

Alias
UMLS CUI [1]
C1285588
Psychiatric history
Description

Psychiatric history

Alias
UMLS CUI-1
C0748059
Psychiatric history
Description

Psychiatric history

Data type

boolean

Alias
UMLS CUI [1]
C0748059
Delusions
Description

delusion

Data type

boolean

Alias
UMLS CUI [1]
C0011253
If yes, please specify
Description

Delsuions specify

Data type

text

Alias
UMLS CUI [1,1]
C0011253
UMLS CUI [1,2]
C1521902
Hallucinations
Description

Hallucinations

Data type

boolean

Alias
UMLS CUI [1]
C0018524
If yes, please specify.
Description

Hallucinations specify

Data type

text

Alias
UMLS CUI [1,1]
C0018524
UMLS CUI [1,2]
C1521902
Affective disorder
Description

Affective disorder

Data type

boolean

Alias
UMLS CUI [1]
C0525045
If yes, please specify.
Description

Affective disorder specify

Data type

text

Alias
UMLS CUI [1,1]
C0525045
UMLS CUI [1,2]
C1521902
Other
Description

psychiatric history other

Data type

boolean

Alias
UMLS CUI [1,1]
C0748059
UMLS CUI [1,2]
C0205394
If yes, please specify.
Description

Other psychiatric history specify

Data type

text

Alias
UMLS CUI [1,1]
C0748059
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Parkinson's Disease medication
Description

Parkinson's Disease medication

Alias
UMLS CUI-1
C0030567
UMLS CUI-2
C0013227
Parkinson's disease medication
Description

Parkinson's disease medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
Parkinson's disease medication
Description

Parkinson's disease medication

Alias
UMLS CUI-1
C0030567
UMLS CUI-2
C0013227
Code
Description

Parkinson's disease medication

Data type

integer

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0805701
Brand name
Description

Parkinson's medication brand name

Data type

text

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0592503
Dosage
Description

Dosage of Parkinson's medication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
Regimen
Description

Parkinson's medication regimen

Data type

text

Alias
UMLS CUI [1]
C0237125
Start date
Description

Start date Parkinson's medication

Data type

partialDate

Measurement units
  • mm/yyyy
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
mm/yyyy
Medication against autonomic dysfunction
Description

Medication against autonomic dysfunction

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C3277919
Mediation against autonomic dysfunction
Description

Pharmaceutical preparation autonomic dysfunction

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3277919
Medication against autonomic dysfunction
Description

Medication against autonomic dysfunction

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C3277919
Brand name
Description

Pharmaceutical preparation autonomic dysfunction Brand name

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3277919
UMLS CUI [1,3]
C0592503
Dosage
Description

Dosage of medication

Data type

text

Alias
UMLS CUI [1]
C3174092
Regimen
Description

Regimen

Data type

text

Alias
UMLS CUI [1]
C0237125
Start date
Description

Medication Start date

Data type

partialDate

Measurement units
  • mm/yyyy
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
mm/yyyy
Antidepressant and antidementive medication
Description

Antidepressant and antidementive medication

Alias
UMLS CUI-1
C0003289
UMLS CUI-3
C0013227
UMLS CUI-4
C0497327
Antidepressant and antidementive medication
Description

Antidepressants and antidementive medication

Data type

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0497327
Antidepressant and antidementive medication
Description

Antidepressant and antidementive medication

Alias
UMLS CUI-1
C0003289
UMLS CUI-2
C0013227
UMLS CUI-3
C0497327
Brand name
Description

Brand name

Data type

text

Alias
UMLS CUI [1]
C0592503
Dosage
Description

Dosage of medication

Data type

text

Alias
UMLS CUI [1]
C3174092
Regimen
Description

Regimen

Data type

text

Alias
UMLS CUI [1]
C0237125
Start date
Description

Medication Start date

Data type

partialDate

Measurement units
  • mm/yyyy
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
mm/yyyy
Other medication
Description

Other medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0205394
Generic name
Description

Generic name

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0592502
indication
Description

Pharmaceutical preparation indication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
Dosage
Description

Dosage of medication

Data type

text

Alias
UMLS CUI [1]
C3174092
Regimen
Description

Regimen

Data type

text

Alias
UMLS CUI [1]
C0237125
Start date
Description

Medication Start date

Data type

partialDate

Measurement units
  • mm/yyyy
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
mm/yyyy
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0031809
Physical examination
Description

Date of physical examination

Data type

date

Alias
UMLS CUI [1]
C2826643
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Temperature
Description

Body Temperature

Data type

integer

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Weight
Description

Weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Description

Body Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
General physical examination
Description

General physical examination

Data type

integer

Alias
UMLS CUI [1]
C0031809
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Code
Description

pHysical examination code

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0805701
Finding
Description

physical examination finding

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
Neurological examination
Description

Neurological examination

Alias
UMLS CUI-1
C0027853
Cranial nerves
Description

Neurologic examination cranial nerves

Data type

integer

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0558819
If abnormal, specify
Description

cranial nerves examination specify

Data type

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0558819
UMLS CUI [1,3]
C1521902
Motor function
Description

Neurologic examination Motor function

Data type

integer

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0234130
If abnormal, specify
Description

Motor function specify

Data type

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0234130
UMLS CUI [1,3]
C1521902
Reflexes
Description

Neurologic examination Reflexes

Data type

integer

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0436145
If abnormal, specify
Description

Reflexes specify

Data type

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0436145
UMLS CUI [1,3]
C1521902
Coordination
Description

Neurologic examination coordination

Data type

integer

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0242414
If abnormal, specify
Description

Coordination specify

Data type

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0242414
UMLS CUI [1,3]
C1521902
Sensation
Description

Neurologic examination sensation

Data type

integer

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0036658
If abnormal, specify
Description

Sensation specify

Data type

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0036658
UMLS CUI [1,3]
C1521902
Pregnancy test
Description

Pregnancy test

Alias
UMLS CUI-1
C0032976
Pregnancy test
Description

Pregnancy test

Data type

integer

Alias
UMLS CUI [1]
C0032976
Laboratory test
Description

Laboratory test

Alias
UMLS CUI-1
C0022885
Date
Description

Date laboratory

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
Laboratory test
Description

Laboratory test

Alias
UMLS CUI-1
C0022885
Type of laboratory procedure
Description

Type of laboratory procedure

Data type

integer

Alias
UMLS CUI [1]
C0022885
Value
Description

Laboratory procedure value

Data type

float

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0587081
Normal
Description

Laboratory result normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0459422
Clinical significant
Description

Laboratory finding significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0750502
Clinically not significant
Description

Laboratory finding not significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C2985739
Not done
Description

Laboratory test not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0445106
Diagnositic criteria for the diagnosis of probable MSA (Gilman et al., 2008)
Description

Diagnositic criteria for the diagnosis of probable MSA (Gilman et al., 2008)

Alias
UMLS CUI-1
C0393571
UMLS CUI-2
C0332148
A sporadic, progressive, adult (>30 y)-onset disease
Description

sporadic, progressive, adult-onset disease

Data type

boolean

Alias
UMLS CUI [1,1]
C2733447
UMLS CUI [1,2]
C1335499
UMLS CUI [1,3]
C1853562
Disease characterised by autonomic failure involving urinary incontinence (inability to control the release of urine from bladder, with erectile dysfunction in males) or an orthostatic decrease of blood pressure within 3 min of standing by at least 30 mmHg systolic or 15 mmHg diastolic
Description

Required criteria for probable MSA

Data type

boolean

Alias
UMLS CUI [1,1]
C2733447
UMLS CUI [1,2]
C0042024
UMLS CUI [2]
C0020651
Poorly levodopa-responsive Parkinsonism (bradykinesia with rigidity, tremor or postural instability) or a cerebellar syndrome (gait ataxia with cerebellar dysarthria, limb ataxia or cerebellar oculomotor dysfunction)
Description

in addition, one of the following criteria must apply.

Data type

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C1853846
UMLS CUI [2,1]
C0231691
UMLS CUI [2,2]
C0454599
UMLS CUI [2,3]
C1411869
Diagnostic criteria for clinical probable MSA apply
Description

criteria for clinical probable MSA

Data type

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0033204
Diagnostic criteria for clinical probable MSA apply
Description

criteria for clinical probable MSA

Data type

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0332148
Diagnositic criteria for the diagnosis of possible MSA (Gilman et al., 2008)
Description

Diagnositic criteria for the diagnosis of possible MSA (Gilman et al., 2008)

Alias
UMLS CUI-1
C0393571
UMLS CUI-2
C2362652
A sporadic, progressive, adult (>30 y)-onset disease
Description

sporadic, progressive, adult-onset disease

Data type

boolean

Alias
UMLS CUI [1,1]
C2733447
UMLS CUI [1,2]
C1335499
UMLS CUI [1,3]
C1853562
Disease characterised by at least one feature suggesting autonomic dysfunction (otherwise urinary urgency, frequency or incomplete bladder emptying, erectile dysfunction in males or significant orthostatic blood pressure decline that does not meet the level required in probable MSA)
Description

MSA autonomic dysfunction

Data type

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C3277919
At least one of the additional features apply.
Description

MSA additional features

Data type

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0332149
Babinski sign with hyperreflexia
Description

Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P or MSA-C

Data type

boolean

Alias
UMLS CUI [1,1]
C0034935
UMLS CUI [1,2]
C0151889
Stridor
Description

Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P or MSA-C

Data type

boolean

Alias
UMLS CUI [1]
C0038450
Rapidly progressive parkinsonism
Description

Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P

Data type

boolean

Alias
UMLS CUI [1,1]
C0030569
UMLS CUI [1,2]
C1335499
Poor response to levodopa
Description

Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C1704632
Postural instability within 3y of motor onset
Description

Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P

Data type

boolean

Alias
UMLS CUI [1]
C1843921
Gait ataxia, cerebellar dysarthria, limb ataxia or cerebellar oculomotor
Description

Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P

Data type

boolean

Alias
UMLS CUI [1,1]
C0231691
UMLS CUI [1,2]
C0454599
UMLS CUI [1,3]
C1411869
Dysphagia within 5y of motor onset
Description

Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P

Data type

boolean

Alias
UMLS CUI [1]
C0011168
Atrophy on MRI of putamen, middle cerebellar peduncle, pons or cerebellum
Description

Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P

Data type

boolean

Alias
UMLS CUI [1]
C0235946
Hypometabolism on FDG-PET in putamen, brainstem or cerebellum
Description

Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-P

Data type

boolean

Alias
UMLS CUI [1,1]
C0347938
UMLS CUI [1,2]
C3641247
Parkinsonism (bradykinesia and rigidity)
Description

Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C

Data type

boolean

Alias
UMLS CUI [1]
C0030569
Atrophy on MRI of putamen, middle cerebellar peduncle or pons
Description

Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C

Data type

boolean

Alias
UMLS CUI [1,1]
C0235946
UMLS CUI [1,2]
C0436540
Hypometabolism on FDG-PET in putamen
Description

Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C

Data type

boolean

Alias
UMLS CUI [1,1]
C0347938
UMLS CUI [1,2]
C3641247
Presynaptic nigrostriatal dopaminergic denervation on SPECT or PET
Description

Additional features of "clinical possible" MSA (Gilman et al., 2008) Possible MSA-C

Data type

boolean

Alias
UMLS CUI [1,1]
C0011307
UMLS CUI [1,2]
C0206129
UMLS CUI [1,3]
C0183126
Diagnostic criteria for clinical possible MSA apply
Description

Diagnostic criteria for clinical possible MSA apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0332149
UMLS CUI [1,3]
C0679228
Features supporting (red flags) a diagnosis of MSA
Description

Features supporting (red flags) a diagnosis of MSA

Alias
UMLS CUI-1
C0393571
UMLS CUI-2
C1457887
Orofacial dystonia
Description

orofacial dystonia

Data type

boolean

Alias
UMLS CUI [1]
C1395979
Disproportionate antecollis
Description

disproportionate antecollis

Data type

boolean

Alias
UMLS CUI [1]
C1698476
Camptocormia (severe anterior flexion of the spine) and/or Pisa syndrome (severe lateral flexion of the spine)
Description

Camptocormia and/or Pisa syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0264162
Contractors of hands or feet
Description

Contractors of hands or feet

Data type

boolean

Alias
UMLS CUI [1,1]
C1140999
UMLS CUI [1,2]
C0018563
UMLS CUI [1,3]
C0016504
Inspiratory sighs
Description

inspiratory sighs

Data type

boolean

Alias
UMLS CUI [1]
C0425481
Severe dysphonia
Description

severe dysphonia

Data type

boolean

Alias
UMLS CUI [1,1]
C1527344
UMLS CUI [1,2]
C0205082
Severe dysarthria
Description

severe dysarthria

Data type

boolean

Alias
UMLS CUI [1,1]
C0013362
UMLS CUI [1,2]
C0205082
New or increased snoring
Description

new or increased snoring

Data type

boolean

Alias
UMLS CUI [1]
C0037384
Cold hands and feet
Description

Cold hands and feet

Data type

boolean

Alias
UMLS CUI [1]
C0857073
Pathologic laughter or crying
Description

Pathologic laughter or crying

Data type

boolean

Alias
UMLS CUI [1,1]
C0424304
UMLS CUI [1,2]
C0860609
Jerky, myoclonic postural/action tremor
Description

Jerky, myoclonic postural/action tremor

Data type

boolean

Alias
UMLS CUI [1,1]
C0234379
UMLS CUI [1,2]
C0234376
Features not supporting a diagnosis of MSA
Description

Features not supporting a diagnosis of MSA

Alias
UMLS CUI-1
C0393571
UMLS CUI-2
C1457887
Classical pill-rolling rest tremor
Description

Classical pill-rolling rest tremor

Data type

boolean

Alias
UMLS CUI [1]
C0751564
Clinically significant neuropathy
Description

Clinically significant neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0442874
Hallucinations not induced by drugs
Description

Hallucinations not induced by drugs

Data type

boolean

Alias
UMLS CUI [1]
C0018524
Onset after age 75y
Description

Onset after age 75y

Data type

boolean

Alias
UMLS CUI [1]
C0206132
Family history of ataxia or parkinsonism
Description

family history of ataxia or parkinsonism

Data type

boolean

Alias
UMLS CUI [1,1]
C2939151
UMLS CUI [1,2]
C0004134
UMLS CUI [1,3]
C0241889
Dementia (on DSM-IV)
Description

Dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
White matter lesions suggesting multiple sclerosis
Description

White matter lesions

Data type

boolean

Alias
UMLS CUI [1]
C2752009
Suspected diagnosis
Description

Suspected diagnosis

Alias
UMLS CUI-1
C0393571
UMLS CUI-2
C0332147
Suspected diagnosis
Description

MSA Suspected diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0332147
Modified Hoehn & Yahr Staging
Description

Modified Hoehn & Yahr Staging

Alias
UMLS CUI-1
C3639878
Modified Hoehn and Yahr Staging
Description

Modified Hoehn and Yahr Staging

Data type

text

Alias
UMLS CUI [1]
C3639878
Hoehn & Yahr Stage <= 3
Description

Hoehn & Yahr Stage

Data type

boolean

Alias
UMLS CUI [1]
C3639878
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
"clinical possible" or "clinical probable" MSA (Gilman et al.)
Description

MSA possible or probable

Data type

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0033204
Hoehn and Yahr Stage I-III
Description

Hoehn and Yahr Stage

Data type

boolean

Alias
UMLS CUI [1]
C3639483
A stable regimen for at least 1 month prior to V1 and willingness / no foreseeable need to change the regimen throughout the 52 week follow-up period for a. drugs acting against Parkinsonism (e.g. Levodopa, Dopamine-Agonists, Amantadine and MAO-B-Inhibitors) b. drugs acting against autonomic dysfunction (e.g. ephedrin, midodrin, fludrucortison, octreotide, desmopresin, oxybutinine) c. antidepressant and antidementive drugs.
Description

If no, later revision possible.

Data type

boolean

Alias
UMLS CUI [1,1]
C0393571
UMLS CUI [1,2]
C0237125
UMLS CUI [1,3]
C0205360
No regular consumption of ECGC, green tea or more than two cups of black tea per day.
Description

consumption of ECGC

Data type

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C1384640
Capability and willingness to give written informed consent indicating that the subject has been informed of and understood all aspects pertinent to the study.
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Capability and willingness to comply with the procedures of the study.
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Contraception by adequate contraceptive methods (oral, injected or implanted hormonal contraceptive methods, intrauterine passer, sterilisation or real abstinence) in all female patients with childbearing potential.
Description

Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Absence of liver disease documented by transaminases and bilirubin below 2-folds of the upper normal level.
Description

liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
All inclusion criteria apply.
Description

Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Hoehn & Yahr stage > III (loss of postural reflexes, no independent walking possible, inability to stand unassisted, wheelchair-bound).
Description

Hoehn & Yahr stage

Data type

boolean

Alias
UMLS CUI [1]
C0451215
Neurodegenerative diseases other than MSA
Description

Neurodegenerative disease

Data type

boolean

Alias
UMLS CUI [1]
C0524851
Severe liver disease with elevation of transaminases and bilirubin above 2-folds of the upper normal level or regular intake of hepatotoxic drugs
Description

severe liver disease or regular intake of hepatotoxic drugs

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0235378
Known hypersensitivity to EGCG or to drugs with similar chemical structure
Description

hypersensitivity to EGCG

Data type

boolean

Alias
UMLS CUI [1,1]
C0059438
UMLS CUI [1,2]
C0020517
Participation in another clinical trial involving administration of an investigational medicinal product within 1 month prior to V1.
Description

Participation in other clinical trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
A physical or psychiatric condition, which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Persistent abuse of medication, drugs or alcohol
Description

abuse of medication, drugs or alcohol

Data type

boolean

Alias
UMLS CUI [1]
C0038586
Consumption of > 500 ml grapefruit juice per day (leading to inhibition of cytochrome P-450 isoenzyme 3A4, which may be involved in degradation of EGCG).
Description

Grapefruit juice consumption

Data type

boolean

Alias
UMLS CUI [1,1]
C0452456
UMLS CUI [1,2]
C0009830
Current or planned pregnancy or breast feeding in females
Description

Pregnancy or breast feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Females of childbearing potential, who are not using medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices).
Description

Contraceptive method

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Intake of COMT-inhibitors (e.g. Entacapone, Tolcapone)
Description

COMT-inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C3536821
Current or planned therapy with Bortezomib and/ or history of plasmocytoma
Description

Bortezomib history of plasmocytoma

Data type

boolean

Alias
UMLS CUI [1]
C0032131
Anemia at screening (Hb < 10g/dL)
Description

Anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
Other severe medical conditions upon discretion of the LKP
Description

Other severe medical conditions

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
All exclusion criteria do not apply.
Description

Exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
Signature of investigator
Description

Signature of investigator

Alias
UMLS CUI-1
C2346576
Date of Investigator Signature
Description

Investigator Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name of investigator
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Investigator signature
Description

I confirm the correctness of the data documented above.

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Screening Visit (V0)

1 forms
  1. StudyEvent: ODM
    1. Screening Visit (V0)
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Screening Visit
C2097637 (UMLS CUI-1)
Date of screening
Item
Date of visit
date
C1710477 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Item
The patient has been thoroughly informed about all purposes and risks pertinent to the study
integer
C0021430 (UMLS CUI [1])
Informed consent
Code List
The patient has been thoroughly informed about all purposes and risks pertinent to the study
CL Item
Yes (1)
CL Item
No (2)
Item
The patient has been thoroughly informed about all purposes and risks pertinent to the study
integer
C0021430 (UMLS CUI [1])
Informed consent
Code List
The patient has been thoroughly informed about all purposes and risks pertinent to the study
CL Item
Yes (1)
CL Item
No (2)
Date of informed consent
Item
Date
date
C2985782 (UMLS CUI [1])
Name MD
Item
Name (MD)
text
C1710470 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
SIgnature investigator
Item
Signature (MD)
text
C2346576 (UMLS CUI [1])
Date informed consent
Item
Date of written informed consent
date
C2985782 (UMLS CUI [1])
Item Group
Demographic Data
C0011298 (UMLS CUI-1)
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
male (1)
CL Item
female (2)
Date of birth
Item
Birth date
date
C0421451 (UMLS CUI [1])
Patient age
Item
Age at screening
integer
C0001779 (UMLS CUI [1])
Item Group
Medical history
C0262926 (UMLS CUI-1)
Item
relevant medical history
integer
C0262926 (UMLS CUI [1])
relevant medical history
Code List
relevant medical history
CL Item
Yes (please specify below) (1)
CL Item
No (2)
Item Group
Medical History
C0262926 (UMLS CUI-1)
Item
Body system
integer
C0262926 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
Body system
Code List
Body system
CL Item
Cardiovascular (01)
CL Item
Pulmonary (02)
CL Item
Abdominal (03)
CL Item
Genitourinary (04)
CL Item
Skeletal/Muscular (05)
CL Item
Surgery/Hospital Admission (06)
CL Item
Other (07)
Diagnosis
Item
Disease/Diagnosis
text
C0011900 (UMLS CUI [1])
Start of disease or surgery
Item
Start of disease or surgery
date
C0012634 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1628561 (UMLS CUI [2])
Start Date not known
Item
Not known
boolean
C0808070 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
End of disease or surgery
Item
End of disease or surgery
date
C4019088 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0444930 (UMLS CUI [2,2])
End date unknown
Item
Not known
boolean
C0806020 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Disease persistent
Item
Persistent
boolean
C0012634 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
Item Group
MSA History
C0393571 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Onset of first symptoms
Item
Onset of first symptoms
date
C0393571 (UMLS CUI [1,1])
C0277793 (UMLS CUI [1,2])
Onset of first symptoms not known
Item
Not known
boolean
C0393571 (UMLS CUI [1,1])
C0277793 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
MSA diagnosis date
Item
Date of first MSA diagnosis
date
C0393571 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
MSA Diagnosis date not known
Item
Not known
boolean
C0393571 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Item
First symptoms
integer
C0393571 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
MSA Type of first symptoms
Code List
First symptoms
CL Item
Autonomic (1)
CL Item
Parkinsonian (2)
CL Item
Cerebellar (3)
CL Item
not known (4)
MSA syncope
Item
Syncope
boolean
C0393571 (UMLS CUI [1,1])
C0039070 (UMLS CUI [1,2])
MSA Orthostatic hypotension
Item
Orthostatic hypotension
boolean
C0393571 (UMLS CUI [1,1])
C0020651 (UMLS CUI [1,2])
MSA Urinary Incontinence
Item
Urinary Incontinence
boolean
C0393571 (UMLS CUI [1,1])
C0042024 (UMLS CUI [1,2])
MSA Erectile Dysfuntion
Item
Erectile Dysfuntion
boolean
C0393571 (UMLS CUI [1,1])
C2733447 (UMLS CUI [1,2])
MSA Other autonomic symptoms
Item
Other (please specify)
text
C0393571 (UMLS CUI [1,1])
C2674101 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
MSA Bradykinesia
Item
Bradykinesia
boolean
C2733447 (UMLS CUI [1,1])
C3176307 (UMLS CUI [1,2])
MSA Rigidity
Item
Rigidity
boolean
C2733447 (UMLS CUI [1,1])
C0858572 (UMLS CUI [1,2])
MSA Tremor
Item
Tremor
boolean
C2733447 (UMLS CUI [1,1])
C0040822 (UMLS CUI [1,2])
Resting tremor
Item
Resting tremor
boolean
C0234379 (UMLS CUI [1])
Postural tremor
Item
Postural tremor
boolean
C0234378 (UMLS CUI [1])
MSA Other parkinsonism symptoms
Item
other (please specify)
text
C2733447 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Onset of falls
Item
Onset of falls
date
C0085639 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Current frequency of falls
integer
C1285588 (UMLS CUI [1])
frequency of falls
Code List
Current frequency of falls
CL Item
several times per day (1)
CL Item
several times per week (2)
CL Item
several times per month (3)
CL Item
several times per year (4)
Item Group
Psychiatric history
C0748059 (UMLS CUI-1)
Psychiatric history
Item
Psychiatric history
boolean
C0748059 (UMLS CUI [1])
delusion
Item
Delusions
boolean
C0011253 (UMLS CUI [1])
Delsuions specify
Item
If yes, please specify
text
C0011253 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Hallucinations
Item
Hallucinations
boolean
C0018524 (UMLS CUI [1])
Hallucinations specify
Item
If yes, please specify.
text
C0018524 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Affective disorder
Item
Affective disorder
boolean
C0525045 (UMLS CUI [1])
Affective disorder specify
Item
If yes, please specify.
text
C0525045 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
psychiatric history other
Item
Other
boolean
C0748059 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other psychiatric history specify
Item
If yes, please specify.
text
C0748059 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Parkinson's Disease medication
C0030567 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Parkinson's disease medication
Item
Parkinson's disease medication
boolean
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Parkinson's disease medication
C0030567 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Item
Code
integer
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Parkinson's disease medication
Code List
Code
CL Item
Levodopa preparation (01)
CL Item
Dopamine Agonists (02)
CL Item
Amantadine (03)
CL Item
Anticholinergic drugs (04)
CL Item
MAO inhibitors (05)
CL Item
COMT inhibitors (Exclusion) (06)
CL Item
other (07)
Parkinson's medication brand name
Item
Brand name
text
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0592503 (UMLS CUI [1,3])
Dosage of Parkinson's medication
Item
Dosage
text
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Parkinson's medication regimen
Item
Regimen
text
C0237125 (UMLS CUI [1])
Start date Parkinson's medication
Item
Start date
partialDate
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item Group
Medication against autonomic dysfunction
C0013227 (UMLS CUI-1)
C3277919 (UMLS CUI-2)
Pharmaceutical preparation autonomic dysfunction
Item
Mediation against autonomic dysfunction
boolean
C0013227 (UMLS CUI [1,1])
C3277919 (UMLS CUI [1,2])
Item Group
Medication against autonomic dysfunction
C0013227 (UMLS CUI-1)
C3277919 (UMLS CUI-2)
Pharmaceutical preparation autonomic dysfunction Brand name
Item
Brand name
text
C0013227 (UMLS CUI [1,1])
C3277919 (UMLS CUI [1,2])
C0592503 (UMLS CUI [1,3])
Dosage of medication
Item
Dosage
text
C3174092 (UMLS CUI [1])
Regimen
Item
Regimen
text
C0237125 (UMLS CUI [1])
Medication Start date
Item
Start date
partialDate
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item Group
Antidepressant and antidementive medication
C0003289 (UMLS CUI-1)
C0013227 (UMLS CUI-3)
C0497327 (UMLS CUI-4)
Antidepressants and antidementive medication
Item
Antidepressant and antidementive medication
boolean
C0003289 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0497327 (UMLS CUI [2,2])
Item Group
Antidepressant and antidementive medication
C0003289 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0497327 (UMLS CUI-3)
Brand name
Item
Brand name
text
C0592503 (UMLS CUI [1])
Dosage of medication
Item
Dosage
text
C3174092 (UMLS CUI [1])
Regimen
Item
Regimen
text
C0237125 (UMLS CUI [1])
Medication Start date
Item
Start date
partialDate
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item Group
Other medication
C0013227 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Generic name
Item
Generic name
text
C0013227 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
Pharmaceutical preparation indication
Item
indication
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Dosage of medication
Item
Dosage
text
C3174092 (UMLS CUI [1])
Regimen
Item
Regimen
text
C0237125 (UMLS CUI [1])
Medication Start date
Item
Start date
partialDate
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item Group
Vital signs
C0031809 (UMLS CUI-1)
Date of physical examination
Item
Physical examination
date
C2826643 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Temperature
integer
C0005903 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
integer
C0031809 (UMLS CUI [1])
General physical examination
Code List
General physical examination
CL Item
normal (1)
CL Item
abnormal (please specify below) (2)
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Code
integer
C0031809 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
pHysical examination code
Code List
Code
CL Item
Cardiovascular (01)
CL Item
Pulmonary (02)
CL Item
Abdominal (03)
CL Item
Genitourinary (04)
CL Item
Skeletal/Muscular (05)
CL Item
Psychiatric (06)
CL Item
other (07)
physical examination finding
Item
Finding
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Item Group
Neurological examination
C0027853 (UMLS CUI-1)
Item
Cranial nerves
integer
C0027853 (UMLS CUI [1,1])
C0558819 (UMLS CUI [1,2])
Neurologic examination cranial nerves
Code List
Cranial nerves
CL Item
normal (1)
CL Item
abnormal (2)
cranial nerves examination specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0558819 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Motor function
integer
C0027853 (UMLS CUI [1,1])
C0234130 (UMLS CUI [1,2])
Neurologic examination Motor function
Code List
Motor function
CL Item
normal (1)
CL Item
abnormal (2)
Motor function specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0234130 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Reflexes
integer
C0027853 (UMLS CUI [1,1])
C0436145 (UMLS CUI [1,2])
Neurologic examination Reflexes
Code List
Reflexes
CL Item
normal (1)
CL Item
abnormal (2)
Reflexes specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0436145 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Coordination
integer
C0027853 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])
Neurologic examination coordination
Code List
Coordination
CL Item
normal (1)
CL Item
abnormal (2)
Coordination specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Sensation
integer
C0027853 (UMLS CUI [1,1])
C0036658 (UMLS CUI [1,2])
Neurologic examination sensation
Code List
Sensation
CL Item
normal (1)
CL Item
abnormal (2)
Sensation specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0036658 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Pregnancy test
C0032976 (UMLS CUI-1)
Item
Pregnancy test
integer
C0032976 (UMLS CUI [1])
Pregnancy test
Code List
Pregnancy test
CL Item
positive (1)
CL Item
negative (2)
CL Item
not applicable (3)
Item Group
Laboratory test
C0022885 (UMLS CUI-1)
Date laboratory
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Item Group
Laboratory test
C0022885 (UMLS CUI-1)
Item
Type of laboratory procedure
integer
C0022885 (UMLS CUI [1])
Type of laboratory procedure
Code List
Type of laboratory procedure
CL Item
Erythrocytes T/l (1)
CL Item
Leukocytes G/l (2)
CL Item
Thrombocytes G/l (3)
CL Item
Hemoglobin g/dl (4)
CL Item
PTT sec (5)
CL Item
PchE kU/l (6)
CL Item
GOT (AST) U/l (7)
CL Item
GPT (ALT) U/l (8)
CL Item
Bilirubin mg/dl (9)
CL Item
Creatinine mg/dl (10)
CL Item
Creatine Kinase U/l (11)
CL Item
Potassium mmil/l (12)
CL Item
Sodium mmil/l (13)
CL Item
GFR ml/min (14)
Laboratory procedure value
Item
Value
float
C0587081 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Laboratory result normal
Item
Normal
boolean
C0587081 (UMLS CUI [1,1])
C0459422 (UMLS CUI [1,2])
Laboratory finding significant
Item
Clinical significant
boolean
C0456984 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Laboratory finding not significant
Item
Clinically not significant
boolean
C0587081 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Laboratory test not done
Item
Not done
boolean
C0022885 (UMLS CUI [1,1])
C0445106 (UMLS CUI [1,2])
Item Group
Diagnositic criteria for the diagnosis of probable MSA (Gilman et al., 2008)
C0393571 (UMLS CUI-1)
C0332148 (UMLS CUI-2)
sporadic, progressive, adult-onset disease
Item
A sporadic, progressive, adult (>30 y)-onset disease
boolean
C2733447 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
C1853562 (UMLS CUI [1,3])
autonomic failure urinary incontinence orthostatic decrease of blood pressure
Item
Disease characterised by autonomic failure involving urinary incontinence (inability to control the release of urine from bladder, with erectile dysfunction in males) or an orthostatic decrease of blood pressure within 3 min of standing by at least 30 mmHg systolic or 15 mmHg diastolic
boolean
C2733447 (UMLS CUI [1,1])
C0042024 (UMLS CUI [1,2])
C0020651 (UMLS CUI [2])
levodopa-responsive Parkinsonism or cerebellar syndrome
Item
Poorly levodopa-responsive Parkinsonism (bradykinesia with rigidity, tremor or postural instability) or a cerebellar syndrome (gait ataxia with cerebellar dysarthria, limb ataxia or cerebellar oculomotor dysfunction)
boolean
C0393571 (UMLS CUI [1,1])
C1853846 (UMLS CUI [1,2])
C0231691 (UMLS CUI [2,1])
C0454599 (UMLS CUI [2,2])
C1411869 (UMLS CUI [2,3])
criteria for clinical probable MSA
Item
Diagnostic criteria for clinical probable MSA apply
boolean
C0393571 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
criteria for clinical probable MSA
Item
Diagnostic criteria for clinical probable MSA apply
boolean
C0393571 (UMLS CUI [1,1])
C0332148 (UMLS CUI [1,2])
Item Group
Diagnositic criteria for the diagnosis of possible MSA (Gilman et al., 2008)
C0393571 (UMLS CUI-1)
C2362652 (UMLS CUI-2)
sporadic, progressive, adult-onset disease
Item
A sporadic, progressive, adult (>30 y)-onset disease
boolean
C2733447 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
C1853562 (UMLS CUI [1,3])
MSA autonomic dysfunction
Item
Disease characterised by at least one feature suggesting autonomic dysfunction (otherwise urinary urgency, frequency or incomplete bladder emptying, erectile dysfunction in males or significant orthostatic blood pressure decline that does not meet the level required in probable MSA)
boolean
C0393571 (UMLS CUI [1,1])
C3277919 (UMLS CUI [1,2])
MSA additional features
Item
At least one of the additional features apply.
boolean
C0393571 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Babinski sign with hyperreflexia
Item
Babinski sign with hyperreflexia
boolean
C0034935 (UMLS CUI [1,1])
C0151889 (UMLS CUI [1,2])
stridor
Item
Stridor
boolean
C0038450 (UMLS CUI [1])
Rapidly progressive parkinsonism
Item
Rapidly progressive parkinsonism
boolean
C0030569 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
Poor response to levodopa
Item
Poor response to levodopa
boolean
C0023570 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
Postural instability
Item
Postural instability within 3y of motor onset
boolean
C1843921 (UMLS CUI [1])
Gait ataxia, cerebellar dysarthria, limb ataxia or cerebellar oculomotor
Item
Gait ataxia, cerebellar dysarthria, limb ataxia or cerebellar oculomotor
boolean
C0231691 (UMLS CUI [1,1])
C0454599 (UMLS CUI [1,2])
C1411869 (UMLS CUI [1,3])
Dysphagia
Item
Dysphagia within 5y of motor onset
boolean
C0011168 (UMLS CUI [1])
Brain atrophy
Item
Atrophy on MRI of putamen, middle cerebellar peduncle, pons or cerebellum
boolean
C0235946 (UMLS CUI [1])
Hypometabolism on FDG-PET in putamen, brainstem or cerebellum
Item
Hypometabolism on FDG-PET in putamen, brainstem or cerebellum
boolean
C0347938 (UMLS CUI [1,1])
C3641247 (UMLS CUI [1,2])
Parkinsonism
Item
Parkinsonism (bradykinesia and rigidity)
boolean
C0030569 (UMLS CUI [1])
Atrophy on MRI
Item
Atrophy on MRI of putamen, middle cerebellar peduncle or pons
boolean
C0235946 (UMLS CUI [1,1])
C0436540 (UMLS CUI [1,2])
Hypometabolism on FDG-PET in putamen
Item
Hypometabolism on FDG-PET in putamen
boolean
C0347938 (UMLS CUI [1,1])
C3641247 (UMLS CUI [1,2])
denervation on SPECT or PET
Item
Presynaptic nigrostriatal dopaminergic denervation on SPECT or PET
boolean
C0011307 (UMLS CUI [1,1])
C0206129 (UMLS CUI [1,2])
C0183126 (UMLS CUI [1,3])
Diagnostic criteria for clinical possible MSA apply
Item
Diagnostic criteria for clinical possible MSA apply
boolean
C0393571 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0679228 (UMLS CUI [1,3])
Item Group
Features supporting (red flags) a diagnosis of MSA
C0393571 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
orofacial dystonia
Item
Orofacial dystonia
boolean
C1395979 (UMLS CUI [1])
disproportionate antecollis
Item
Disproportionate antecollis
boolean
C1698476 (UMLS CUI [1])
Camptocormia and/or Pisa syndrome
Item
Camptocormia (severe anterior flexion of the spine) and/or Pisa syndrome (severe lateral flexion of the spine)
boolean
C0264162 (UMLS CUI [1])
Contractors of hands or feet
Item
Contractors of hands or feet
boolean
C1140999 (UMLS CUI [1,1])
C0018563 (UMLS CUI [1,2])
C0016504 (UMLS CUI [1,3])
inspiratory sighs
Item
Inspiratory sighs
boolean
C0425481 (UMLS CUI [1])
severe dysphonia
Item
Severe dysphonia
boolean
C1527344 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
severe dysarthria
Item
Severe dysarthria
boolean
C0013362 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
new or increased snoring
Item
New or increased snoring
boolean
C0037384 (UMLS CUI [1])
Cold hands and feet
Item
Cold hands and feet
boolean
C0857073 (UMLS CUI [1])
Pathologic laughter or crying
Item
Pathologic laughter or crying
boolean
C0424304 (UMLS CUI [1,1])
C0860609 (UMLS CUI [1,2])
Jerky, myoclonic postural/action tremor
Item
Jerky, myoclonic postural/action tremor
boolean
C0234379 (UMLS CUI [1,1])
C0234376 (UMLS CUI [1,2])
Item Group
Features not supporting a diagnosis of MSA
C0393571 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
Classical pill-rolling rest tremor
Item
Classical pill-rolling rest tremor
boolean
C0751564 (UMLS CUI [1])
Clinically significant neuropathy
Item
Clinically significant neuropathy
boolean
C0442874 (UMLS CUI [1])
Hallucinations not induced by drugs
Item
Hallucinations not induced by drugs
boolean
C0018524 (UMLS CUI [1])
Onset after age 75y
Item
Onset after age 75y
boolean
C0206132 (UMLS CUI [1])
family history of ataxia or parkinsonism
Item
Family history of ataxia or parkinsonism
boolean
C2939151 (UMLS CUI [1,1])
C0004134 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
Dementia
Item
Dementia (on DSM-IV)
boolean
C0497327 (UMLS CUI [1])
White matter lesions
Item
White matter lesions suggesting multiple sclerosis
boolean
C2752009 (UMLS CUI [1])
Item Group
Suspected diagnosis
C0393571 (UMLS CUI-1)
C0332147 (UMLS CUI-2)
Item
Suspected diagnosis
integer
C0393571 (UMLS CUI [1,1])
C0332147 (UMLS CUI [1,2])
MSA Suspected diagnosis
Code List
Suspected diagnosis
CL Item
MSA-P (1)
CL Item
MSA-C (2)
CL Item
Other, please specify (3)
CL Item
Exclusion (4)
Item Group
Modified Hoehn & Yahr Staging
C3639878 (UMLS CUI-1)
Item
Modified Hoehn and Yahr Staging
text
C3639878 (UMLS CUI [1])
Modified Hoehn and Yahr Staging
Code List
Modified Hoehn and Yahr Staging
CL Item
No signs of disease. (Stage 0)
CL Item
Unilateral disease. (Stage 1)
CL Item
Unilateral plus axial involvement. (Stage 1.5)
CL Item
Bilateral disease, without impairment of balance. (Stage 2)
CL Item
Mild bilateral disease, with recovery on pull test. (Stage 2.5)
CL Item
Mild to moderate bilateral disease; some postural instability; Physically independent. (Stage 3)
CL Item
Severe disability; still able to walk or stand unassisted. (Stage 4)
CL Item
Wheelchair bound or bedridden unless aided. (Stage 5)
Hoehn & Yahr Stage
Item
Hoehn & Yahr Stage <= 3
boolean
C3639878 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
MSA possible or probable
Item
"clinical possible" or "clinical probable" MSA (Gilman et al.)
boolean
C0393571 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
Hoehn and Yahr Stage
Item
Hoehn and Yahr Stage I-III
boolean
C3639483 (UMLS CUI [1])
MSA stable regimen
Item
A stable regimen for at least 1 month prior to V1 and willingness / no foreseeable need to change the regimen throughout the 52 week follow-up period for a. drugs acting against Parkinsonism (e.g. Levodopa, Dopamine-Agonists, Amantadine and MAO-B-Inhibitors) b. drugs acting against autonomic dysfunction (e.g. ephedrin, midodrin, fludrucortison, octreotide, desmopresin, oxybutinine) c. antidepressant and antidementive drugs.
boolean
C0393571 (UMLS CUI [1,1])
C0237125 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
consumption of ECGC
Item
No regular consumption of ECGC, green tea or more than two cups of black tea per day.
boolean
C0009830 (UMLS CUI [1,1])
C1384640 (UMLS CUI [1,2])
Written informed consent
Item
Capability and willingness to give written informed consent indicating that the subject has been informed of and understood all aspects pertinent to the study.
boolean
C0021430 (UMLS CUI [1])
Compliance
Item
Capability and willingness to comply with the procedures of the study.
boolean
C1321605 (UMLS CUI [1])
Contraception
Item
Contraception by adequate contraceptive methods (oral, injected or implanted hormonal contraceptive methods, intrauterine passer, sterilisation or real abstinence) in all female patients with childbearing potential.
boolean
C0700589 (UMLS CUI [1])
liver disease
Item
Absence of liver disease documented by transaminases and bilirubin below 2-folds of the upper normal level.
boolean
C0023895 (UMLS CUI [1])
Inclusion criteria
Item
All inclusion criteria apply.
boolean
C1512693 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Hoehn & Yahr stage
Item
Hoehn & Yahr stage > III (loss of postural reflexes, no independent walking possible, inability to stand unassisted, wheelchair-bound).
boolean
C0451215 (UMLS CUI [1])
Neurodegenerative disease
Item
Neurodegenerative diseases other than MSA
boolean
C0524851 (UMLS CUI [1])
severe liver disease or regular intake of hepatotoxic drugs
Item
Severe liver disease with elevation of transaminases and bilirubin above 2-folds of the upper normal level or regular intake of hepatotoxic drugs
boolean
C0023895 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0235378 (UMLS CUI [2,2])
hypersensitivity to EGCG
Item
Known hypersensitivity to EGCG or to drugs with similar chemical structure
boolean
C0059438 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Participation in other clinical trial
Item
Participation in another clinical trial involving administration of an investigational medicinal product within 1 month prior to V1.
boolean
C2348568 (UMLS CUI [1])
Comorbidity
Item
A physical or psychiatric condition, which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial
boolean
C0009488 (UMLS CUI [1])
abuse of medication, drugs or alcohol
Item
Persistent abuse of medication, drugs or alcohol
boolean
C0038586 (UMLS CUI [1])
Grapefruit juice consumption
Item
Consumption of > 500 ml grapefruit juice per day (leading to inhibition of cytochrome P-450 isoenzyme 3A4, which may be involved in degradation of EGCG).
boolean
C0452456 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
Pregnancy or breast feeding
Item
Current or planned pregnancy or breast feeding in females
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Contraceptive method
Item
Females of childbearing potential, who are not using medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices).
boolean
C0700589 (UMLS CUI [1])
COMT-inhibitors
Item
Intake of COMT-inhibitors (e.g. Entacapone, Tolcapone)
boolean
C3536821 (UMLS CUI [1])
Bortezomib history of plasmocytoma
Item
Current or planned therapy with Bortezomib and/ or history of plasmocytoma
boolean
C0032131 (UMLS CUI [1])
Anemia
Item
Anemia at screening (Hb < 10g/dL)
boolean
C0002871 (UMLS CUI [1])
Other severe medical conditions
Item
Other severe medical conditions upon discretion of the LKP
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Exclusion criteria
Item
All exclusion criteria do not apply.
boolean
C0680251 (UMLS CUI [1])
Item Group
Signature of investigator
C2346576 (UMLS CUI-1)
Investigator Signature Date
Item
Date of Investigator Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Name of investigator
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
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