ID

44407

Description

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

Keywords

Versions (2)
  1. 8/24/18 8/24/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT01628965

English

Eligibility Parkinson's Disease NCT01628965

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Study Subject Completed Clinical Trial Preceding

Data type

boolean

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

Exclusion Criteria

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

Patient withdrawn from Clinical Trial Preceding

Data type

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.
Description

Serious Adverse Event | Relationship Investigational New Drugs

Data type

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.
Description

Serious Adverse Event Persistent | Relationship Investigational New Drugs Excluded

Data type

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.
Description

Hallucinations Persistent | Delusions Persistent

Data type

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.
Description

Mental condition | Confusion | Excitement | Delirium | Abnormal behavior

Data type

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.
Description

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

Data type

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.
Description

Epilepsy | Convulsions

Data type

boolean

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

ECG abnormality Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0522055
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.
Description

Prolonged QTc interval | Gender

Data type

boolean

Alias
UMLS CUI [1]
C1560305
UMLS CUI [2]
C0079399
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Similar models

Eligibility Parkinson's Disease NCT01628965

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
C0522055 (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])
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