ID

31464

Beschreibung

A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01628965

Link

https://clinicaltrials.gov/show/NCT01628965

Stichworte

Versionen (2)
  1. 24.08.18 24.08.18 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

24. August 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT01628965

Englisch

Eligibility Parkinson's Disease NCT01628965

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject completed the preceding trial 243-07-001 (nct00537485)
Beschreibung

Study Subject Completed Clinical Trial Preceding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0332152
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject discontinued from the preceding trial 243-07-001.
Beschreibung

Patient withdrawn from Clinical Trial Preceding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0332152
subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-07-001.
Beschreibung

Serious Adverse Event | Relationship Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0013230
subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-07-001.
Beschreibung

Serious Adverse Event Persistent | Relationship Investigational New Drugs Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0205322
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0332196
subject had persistent hallucination or delusion during trial 243-07-001.
Beschreibung

Hallucinations Persistent | Delusions Persistent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018524
UMLS CUI [1,2]
C0205322
UMLS CUI [2,1]
C0011253
UMLS CUI [2,2]
C0205322
subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
Beschreibung

Mental condition | Confusion | Excitement | Delirium | Abnormal behavior

Datentyp

boolean

Alias
UMLS CUI [1]
C3840291
UMLS CUI [2]
C0009676
UMLS CUI [3]
C0233571
UMLS CUI [4]
C0011206
UMLS CUI [5]
C0233514
subject has orthostatic hypotension or a systolic blood pressure (sbp) <= 100 mmhg and has a decrease of sbp from spine to standing position >= 30 mmhg at baseline.
Beschreibung

Hypotension, Orthostatic | Systolic Pressure | Decreased systolic arterial pressure Supine Position Standing position

Datentyp

boolean

Alias
UMLS CUI [1]
C0020651
UMLS CUI [2]
C0871470
UMLS CUI [3,1]
C0277885
UMLS CUI [3,2]
C0038846
UMLS CUI [3,3]
C0231472
subject has a history of epilepsy, convulsion etc. during trial 243-07-001.
Beschreibung

Epilepsy | Convulsions

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C4048158
subject develops serious ecg abnormality at the baseline.
Beschreibung

ECG abnormality Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C0205404
subject has qtc-interval >= 500 msec at the baseline or subject has an increase of qtc-interval >= 60 msec from the baseline in the trial 243-07-001 and has a qtc-interval > 470 msec in female or > 450 msec in male at the baseline.
Beschreibung

Prolonged QTc interval | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C1560305
UMLS CUI [2]
C0079399
subject has a serum potassium level < 3.5 meq/l at the end of the taper period in trial 243-07-001.
Beschreibung

Serum potassium measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0302353
subject has a total bilirubin >= 3.0 mg/dl or ast(got) or alt(gpt) greater than 2.5 times of the upper limit of the reference range (or >= 100 iu/l) at the end of the period in trial 243-07-001.
Beschreibung

Serum total bilirubin measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
subject has bun >= 30 mg/dl or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-07-001.
Beschreibung

Blood urea nitrogen measurement | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0005845
UMLS CUI [2]
C0201976
subject who plans pregnancy during the trial.
Beschreibung

Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032992
subject has dementia.
Beschreibung

Dementia

Datentyp

boolean

Alias
UMLS CUI [1]
C0497327
subject is unable to give consent.
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.
Beschreibung

Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Ähnliche Modelle

Eligibility Parkinson's Disease NCT01628965

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Completed Clinical Trial Preceding
Item
subject completed the preceding trial 243-07-001 (nct00537485)
boolean
C0681850 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Patient withdrawn from Clinical Trial Preceding
Item
subject discontinued from the preceding trial 243-07-001.
boolean
C0422727 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Serious Adverse Event | Relationship Investigational New Drugs
Item
subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-07-001.
boolean
C1519255 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Serious Adverse Event Persistent | Relationship Investigational New Drugs Excluded
Item
subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-07-001.
boolean
C1519255 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Hallucinations Persistent | Delusions Persistent
Item
subject had persistent hallucination or delusion during trial 243-07-001.
boolean
C0018524 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0011253 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
Mental condition | Confusion | Excitement | Delirium | Abnormal behavior
Item
subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
boolean
C3840291 (UMLS CUI [1])
C0009676 (UMLS CUI [2])
C0233571 (UMLS CUI [3])
C0011206 (UMLS CUI [4])
C0233514 (UMLS CUI [5])
Hypotension, Orthostatic | Systolic Pressure | Decreased systolic arterial pressure Supine Position Standing position
Item
subject has orthostatic hypotension or a systolic blood pressure (sbp) <= 100 mmhg and has a decrease of sbp from spine to standing position >= 30 mmhg at baseline.
boolean
C0020651 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0277885 (UMLS CUI [3,1])
C0038846 (UMLS CUI [3,2])
C0231472 (UMLS CUI [3,3])
Epilepsy | Convulsions
Item
subject has a history of epilepsy, convulsion etc. during trial 243-07-001.
boolean
C0014544 (UMLS CUI [1])
C4048158 (UMLS CUI [2])
ECG abnormality Serious
Item
subject develops serious ecg abnormality at the baseline.
boolean
C1832603 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Prolonged QTc interval | Gender
Item
subject has qtc-interval >= 500 msec at the baseline or subject has an increase of qtc-interval >= 60 msec from the baseline in the trial 243-07-001 and has a qtc-interval > 470 msec in female or > 450 msec in male at the baseline.
boolean
C1560305 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Serum potassium measurement
Item
subject has a serum potassium level < 3.5 meq/l at the end of the taper period in trial 243-07-001.
boolean
C0302353 (UMLS CUI [1])
Serum total bilirubin measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
subject has a total bilirubin >= 3.0 mg/dl or ast(got) or alt(gpt) greater than 2.5 times of the upper limit of the reference range (or >= 100 iu/l) at the end of the period in trial 243-07-001.
boolean
C1278039 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Blood urea nitrogen measurement | Creatinine measurement, serum
Item
subject has bun >= 30 mg/dl or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-07-001.
boolean
C0005845 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Pregnancy, Planned
Item
subject who plans pregnancy during the trial.
boolean
C0032992 (UMLS CUI [1])
Dementia
Item
subject has dementia.
boolean
C0497327 (UMLS CUI [1])
Informed Consent Unable
Item
subject is unable to give consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status Inappropriate
Item
subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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