Informações:
Falhas:
ID
28016
Descrição
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
Palavras-chave
Versões (1)
- 10/12/2017 10/12/2017 -
Titular dos direitos
Priv.-Doz. Dr. med. Johannes Levin
Transferido a
10 de dezembro de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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PROMESA NCT02008721
Similar models
Screening Visit (V0)
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Date of screening
Item
Date of visit
date
C1710477 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
The patient has been thoroughly informed about all purposes and risks pertinent to the study
integer
C0021430 (UMLS CUI [1])
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])
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])
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])
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])
CL Item
Yes (please specify below) (1)
CL Item
No (2)
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])
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])
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])
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])
C0439673 (UMLS CUI [1,2])
Disease persistent
Item
Persistent
boolean
C0012634 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,2])
Onset of first symptoms
Item
Onset of first symptoms
date
C0393571 (UMLS CUI [1,1])
C0277793 (UMLS CUI [1,2])
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])
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])
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])
C2316983 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Item
First symptoms
integer
C0393571 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
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])
C0039070 (UMLS CUI [1,2])
MSA Orthostatic hypotension
Item
Orthostatic hypotension
boolean
C0393571 (UMLS CUI [1,1])
C0020651 (UMLS CUI [1,2])
C0020651 (UMLS CUI [1,2])
MSA Urinary Incontinence
Item
Urinary Incontinence
boolean
C0393571 (UMLS CUI [1,1])
C0042024 (UMLS CUI [1,2])
C0042024 (UMLS CUI [1,2])
MSA Erectile Dysfuntion
Item
Erectile Dysfuntion
boolean
C0393571 (UMLS CUI [1,1])
C2733447 (UMLS CUI [1,2])
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])
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])
C3176307 (UMLS CUI [1,2])
MSA Rigidity
Item
Rigidity
boolean
C2733447 (UMLS CUI [1,1])
C0858572 (UMLS CUI [1,2])
C0858572 (UMLS CUI [1,2])
MSA Tremor
Item
Tremor
boolean
C2733447 (UMLS CUI [1,1])
C0040822 (UMLS CUI [1,2])
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])
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])
C0574845 (UMLS CUI [1,2])
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)
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])
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])
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])
C1521902 (UMLS CUI [1,2])
psychiatric history other
Item
Other
boolean
C0748059 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Parkinson's Disease medication
C0030567 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0013227 (UMLS CUI-2)
Parkinson's disease medication
Item
Parkinson's disease medication
boolean
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Item Group
Parkinson's disease medication
C0030567 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0013227 (UMLS CUI-2)
Item
Code
integer
C0030567 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
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])
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])
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])
C0808070 (UMLS CUI [1,2])
Item Group
Medication against autonomic dysfunction
C0013227 (UMLS CUI-1)
C3277919 (UMLS CUI-2)
C3277919 (UMLS CUI-2)
Pharmaceutical preparation autonomic dysfunction
Item
Mediation against autonomic dysfunction
boolean
C0013227 (UMLS CUI [1,1])
C3277919 (UMLS CUI [1,2])
C3277919 (UMLS CUI [1,2])
Item Group
Medication against autonomic dysfunction
C0013227 (UMLS CUI-1)
C3277919 (UMLS CUI-2)
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])
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])
C0808070 (UMLS CUI [1,2])
Item Group
Antidepressant and antidementive medication
C0003289 (UMLS CUI-1)
C0013227 (UMLS CUI-3)
C0497327 (UMLS CUI-4)
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])
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)
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])
C0808070 (UMLS CUI [1,2])
Item Group
Other medication
C0013227 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI-2)
Generic name
Item
Generic name
text
C0013227 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
C0592502 (UMLS CUI [1,2])
Pharmaceutical preparation indication
Item
indication
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
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])
C0808070 (UMLS CUI [1,2])
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])
CL Item
normal (1)
CL Item
abnormal (please specify below) (2)
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])
C0243095 (UMLS CUI [1,2])
Item
Cranial nerves
integer
C0027853 (UMLS CUI [1,1])
C0558819 (UMLS CUI [1,2])
C0558819 (UMLS CUI [1,2])
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])
C0558819 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Motor function
integer
C0027853 (UMLS CUI [1,1])
C0234130 (UMLS CUI [1,2])
C0234130 (UMLS CUI [1,2])
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])
C0234130 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Reflexes
integer
C0027853 (UMLS CUI [1,1])
C0436145 (UMLS CUI [1,2])
C0436145 (UMLS CUI [1,2])
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])
C0436145 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Coordination
integer
C0027853 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,2])
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])
C0242414 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Sensation
integer
C0027853 (UMLS CUI [1,1])
C0036658 (UMLS CUI [1,2])
C0036658 (UMLS CUI [1,2])
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])
C0036658 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
CL Item
positive (1)
CL Item
negative (2)
CL Item
not applicable (3)
Date laboratory
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
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])
C0587081 (UMLS CUI [1,2])
Laboratory result normal
Item
Normal
boolean
C0587081 (UMLS CUI [1,1])
C0459422 (UMLS CUI [1,2])
C0459422 (UMLS CUI [1,2])
Laboratory finding significant
Item
Clinical significant
boolean
C0456984 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,2])
Laboratory finding not significant
Item
Clinically not significant
boolean
C0587081 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Laboratory test not done
Item
Not done
boolean
C0022885 (UMLS CUI [1,1])
C0445106 (UMLS CUI [1,2])
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)
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])
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])
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])
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])
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])
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)
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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)
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])
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])
C0205082 (UMLS CUI [1,2])
severe dysarthria
Item
Severe dysarthria
boolean
C0013362 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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])
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])
C0234376 (UMLS CUI [1,2])
Item Group
Features not supporting a diagnosis of MSA
C0393571 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
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])
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
Suspected diagnosis
integer
C0393571 (UMLS CUI [1,1])
C0332147 (UMLS CUI [1,2])
C0332147 (UMLS CUI [1,2])
CL Item
MSA-P (1)
CL Item
MSA-C (2)
CL Item
Other, please specify (3)
CL Item
Exclusion (4)
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0205082 (UMLS CUI [1,2])
Exclusion criteria
Item
All exclusion criteria do not apply.
boolean
C0680251 (UMLS CUI [1])
Investigator Signature Date
Item
Date of Investigator Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])