ID

43019

Beskrivning

Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00642928

Länk

https://clinicaltrials.gov/show/NCT00642928

Nyckelord

Versioner (2)
  1. 2018-03-21 2018-03-21 -
  2. 2021-09-17 2021-09-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Excessive Daytime Sleepiness NCT00642928

Engelsk

Eligibility Excessive Daytime Sleepiness NCT00642928

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
idiopathic parkinson disease
Beskrivning

Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
hoehn and yahr < 5
Beskrivning

Hoehn and Yahr Scale score

Datatyp

boolean

Alias
UMLS CUI [1]
C4274823
stable treatment of parkinson disease for at least 4 weeks
Beskrivning

Therapeutic procedure Stable Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0030567
excessive daytime sleepiness : epworth scale superior or equal to 13
Beskrivning

Excessive daytime somnolence Epworth Sleepiness Scale Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4551761
UMLS CUI [1,2]
C3541276
none psychostimulant treatment intake for 2 weeks
Beskrivning

Psychostimulant Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0304403
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
other degenerative parkinsonian syndrome
Beskrivning

Parkinsonian syndrome degenerative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242422
UMLS CUI [1,2]
C0011164
other condition than pd that is the primary cause of excessive daytime sleepiness
Beskrivning

Condition Etiology Excessive daytime somnolence | Exception Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C4551761
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030567
severe depression or suicidal risk
Beskrivning

Severe depression | At risk for suicide

Datatyp

boolean

Alias
UMLS CUI [1]
C0588008
UMLS CUI [2]
C0563664
pregnant or breast-feeding women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients having an occupation that requires night shift
Beskrivning

Night shift worker

Datatyp

boolean

Alias
UMLS CUI [1]
C0555008
history of drugs, alcohol, narcotic or other substance abuse or dependence
Beskrivning

Substance Use Disorders | Substance Dependence | Narcotic Abuse | Narcotic Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
UMLS CUI [3]
C0524661
UMLS CUI [4]
C1527402
refusal from the patient to stop any current therapy for excessive daytime sleepiness or predictable risks for the patient to stop the therapy
Beskrivning

Excessive daytime somnolence | Therapeutic procedure Discontinue Refused | Therapeutic procedure Discontinue At risk Patient

Datatyp

boolean

Alias
UMLS CUI [1]
C4551761
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1705116
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C1444641
UMLS CUI [3,4]
C0030705
any significant abnormality in the physical examination or clinical laboratory results e.g. liver or kidney function deficiency
Beskrivning

Physical Examination Abnormal Finding | Laboratory test result abnormal | Liver Dysfunction | Renal Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C2826636
UMLS CUI [2]
C0438215
UMLS CUI [3]
C0086565
UMLS CUI [4]
C1565489
any significant serious abnormality of the ecg e.g. myocardial infarction,
Beskrivning

Electrocardiogram abnormal | Electrocardiogram: myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C0428953
electrocardiogram corrected qt interval higher than 450 ms
Beskrivning

Electrocardiogram QT corrected interval

Datatyp

boolean

Alias
UMLS CUI [1]
C0855331
other active clinically significant illness which could interfere with the study conduct or contra-indicate the study treatments or put patients at risk
Beskrivning

Illness Interferes with Study Execution | Illness Medical contraindication Investigational Therapy | Illness At risk Patient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0681872
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C1301624
UMLS CUI [2,3]
C0949266
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0030705
dementia with mms inferior or equal to 24
Beskrivning

Dementia | Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0451306
patients taking associated treatments which are not allowed during the study course and which cannot be stopped before the inclusion visit
Beskrivning

Therapeutic procedure Associated Illicit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0332266
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Similar models

Eligibility Excessive Daytime Sleepiness NCT00642928

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
idiopathic parkinson disease
boolean
C0030567 (UMLS CUI [1])
Hoehn and Yahr Scale score
Item
hoehn and yahr < 5
boolean
C4274823 (UMLS CUI [1])
Therapeutic procedure Stable Parkinson Disease
Item
stable treatment of parkinson disease for at least 4 weeks
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Excessive daytime somnolence Epworth Sleepiness Scale Questionnaire
Item
excessive daytime sleepiness : epworth scale superior or equal to 13
boolean
C4551761 (UMLS CUI [1,1])
C3541276 (UMLS CUI [1,2])
Psychostimulant Absent
Item
none psychostimulant treatment intake for 2 weeks
boolean
C0304403 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Parkinsonian syndrome degenerative
Item
other degenerative parkinsonian syndrome
boolean
C0242422 (UMLS CUI [1,1])
C0011164 (UMLS CUI [1,2])
Condition Etiology Excessive daytime somnolence | Exception Parkinson Disease
Item
other condition than pd that is the primary cause of excessive daytime sleepiness
boolean
C0348080 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C4551761 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0030567 (UMLS CUI [2,2])
Severe depression | At risk for suicide
Item
severe depression or suicidal risk
boolean
C0588008 (UMLS CUI [1])
C0563664 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Night shift worker
Item
patients having an occupation that requires night shift
boolean
C0555008 (UMLS CUI [1])
Substance Use Disorders | Substance Dependence | Narcotic Abuse | Narcotic Dependence
Item
history of drugs, alcohol, narcotic or other substance abuse or dependence
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C0524661 (UMLS CUI [3])
C1527402 (UMLS CUI [4])
Excessive daytime somnolence | Therapeutic procedure Discontinue Refused | Therapeutic procedure Discontinue At risk Patient
Item
refusal from the patient to stop any current therapy for excessive daytime sleepiness or predictable risks for the patient to stop the therapy
boolean
C4551761 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1705116 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0030705 (UMLS CUI [3,4])
Physical Examination Abnormal Finding | Laboratory test result abnormal | Liver Dysfunction | Renal Insufficiency
Item
any significant abnormality in the physical examination or clinical laboratory results e.g. liver or kidney function deficiency
boolean
C2826636 (UMLS CUI [1])
C0438215 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C1565489 (UMLS CUI [4])
Electrocardiogram abnormal | Electrocardiogram: myocardial infarction
Item
any significant serious abnormality of the ecg e.g. myocardial infarction,
boolean
C0522055 (UMLS CUI [1])
C0428953 (UMLS CUI [2])
Electrocardiogram QT corrected interval
Item
electrocardiogram corrected qt interval higher than 450 ms
boolean
C0855331 (UMLS CUI [1])
Illness Interferes with Study Execution | Illness Medical contraindication Investigational Therapy | Illness At risk Patient
Item
other active clinically significant illness which could interfere with the study conduct or contra-indicate the study treatments or put patients at risk
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0681872 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C0949266 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0030705 (UMLS CUI [3,3])
Dementia | Mini-mental state examination
Item
dementia with mms inferior or equal to 24
boolean
C0497327 (UMLS CUI [1])
C0451306 (UMLS CUI [2])
Therapeutic procedure Associated Illicit
Item
patients taking associated treatments which are not allowed during the study course and which cannot be stopped before the inclusion visit
boolean
C0087111 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0332266 (UMLS CUI [1,3])
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