ID

31464

Descripción

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

Palabras clave

Versiones (2)
  1. 24/8/18 24/8/18 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

24 de agosto de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT01628965

Inglés

Eligibility Parkinson's Disease NCT01628965

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Study Subject Completed Clinical Trial Preceding

Tipo de datos

boolean

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

Exclusion Criteria

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

Patient withdrawn from Clinical Trial Preceding

Tipo de datos

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.
Descripción

Serious Adverse Event | Relationship Investigational New Drugs

Tipo de datos

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.
Descripción

Serious Adverse Event Persistent | Relationship Investigational New Drugs Excluded

Tipo de datos

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.
Descripción

Hallucinations Persistent | Delusions Persistent

Tipo de datos

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.
Descripción

Mental condition | Confusion | Excitement | Delirium | Abnormal behavior

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Epilepsy | Convulsions

Tipo de datos

boolean

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

ECG abnormality Serious

Tipo de datos

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.
Descripción

Prolonged QTc interval | Gender

Tipo de datos

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.
Descripción

Serum potassium measurement

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Blood urea nitrogen measurement | Creatinine measurement, serum

Tipo de datos

boolean

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

Pregnancy, Planned

Tipo de datos

boolean

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

Dementia

Tipo de datos

boolean

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

Informed Consent Unable

Tipo de datos

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.
Descripción

Study Subject Participation Status Inappropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Parkinson's Disease NCT01628965

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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