ID

43686

Description

A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Study of NS 2330 (Tesofensine) (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations; ODM derived from: https://clinicaltrials.gov/show/NCT00148512

Link

https://clinicaltrials.gov/show/NCT00148512

Keywords

Versions (2)
  1. 11/20/16 11/20/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00148512

English

Eligibility Parkinson Disease NCT00148512

1 forms  
Criteria
Description

Criteria

male or female patient with idiopathic parkinson disease (pd) diagnosed for at least 2 years.
Description

Gender | Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0030567
patient aged 40 years or over at time of diagnosis of pd and not older than 80 years at screening visit.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
modified hoehn and yahr stage of ii to iii at "on" time.
Description

UPDRS - Modified Hoehn and Yahr Staging

Data type

boolean

Alias
UMLS CUI [1]
C3639878
treatment with levodopa at an optimised dose, 4 to 8 times per day, this dose being stable for at least 4 weeks prior to screening visit.
Description

Levodopa Dose times/day Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439511
UMLS CUI [1,4]
C0205360
motor fluctuations, with 2.0 to 6.0 cumulative hours of "off" time every day during waking hours, documented from patient's diary completed for 2 consecutive days before baseline visit.
Description

Motor fluctuations Duration Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C1868976
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0332173
main exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
neuropsychiatric exclusions: non-idiopathic pd, dementia (mini mental state exam <26), history of psychosis, history or current axis i or axis ii mental disorder according to dsm-iv, etc
Description

Exclusion Neurologic Psychiatric | Parkinson Disease | Dementia | Mini-mental state examination | Psychotic Disorders | Axis I diagnosis | Axis II diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0205494
UMLS CUI [1,3]
C0205487
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0497327
UMLS CUI [4]
C0451306
UMLS CUI [5]
C0033975
UMLS CUI [6]
C0270287
UMLS CUI [7]
C0270288
other medical exclusions, like ecg abnormalities, hypotension and/or symptomatic orthostatic hypotension, some abnormal laboratory parameters (e.g. severe renal impairment), etc
Description

Exclusion Medical | ECG abnormality | Hypotension | Hypotension orthostatic symptomatic | Laboratory test result abnormal | Renal Insufficiency Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0205476
UMLS CUI [2]
C0522055
UMLS CUI [3]
C0020649
UMLS CUI [4]
C0740482
UMLS CUI [5]
C0438215
UMLS CUI [6,1]
C1565489
UMLS CUI [6,2]
C0205082
pharmacological exclusions, e.g. selegiline within 8 weeks prior to screening visit, regular use of anti-depressant drugs, any medication with central dopaminergic antagonist activity, etc
Description

Exclusion pharmacological | Selegiline | Antidepressive Agents Use Regular | Dopamine Antagonists | Pharmaceutical Preparations Dopamine Antagonists Containing

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0205464
UMLS CUI [2]
C0036579
UMLS CUI [3,1]
C0003289
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C0205272
UMLS CUI [4]
C0242702
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0242702
UMLS CUI [5,3]
C0332256
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Similar models

Eligibility Parkinson Disease NCT00148512

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Gender | Parkinson Disease
Item
male or female patient with idiopathic parkinson disease (pd) diagnosed for at least 2 years.
boolean
C0079399 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
Age
Item
patient aged 40 years or over at time of diagnosis of pd and not older than 80 years at screening visit.
boolean
C0001779 (UMLS CUI [1])
UPDRS - Modified Hoehn and Yahr Staging
Item
modified hoehn and yahr stage of ii to iii at "on" time.
boolean
C3639878 (UMLS CUI [1])
Levodopa Dose times/day Stable
Item
treatment with levodopa at an optimised dose, 4 to 8 times per day, this dose being stable for at least 4 weeks prior to screening visit.
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439511 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Motor fluctuations Duration Daily
Item
motor fluctuations, with 2.0 to 6.0 cumulative hours of "off" time every day during waking hours, documented from patient's diary completed for 2 consecutive days before baseline visit.
boolean
C1868976 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Exclusion Neurologic Psychiatric | Parkinson Disease | Dementia | Mini-mental state examination | Psychotic Disorders | Axis I diagnosis | Axis II diagnosis
Item
neuropsychiatric exclusions: non-idiopathic pd, dementia (mini mental state exam <26), history of psychosis, history or current axis i or axis ii mental disorder according to dsm-iv, etc
boolean
C2828389 (UMLS CUI [1,1])
C0205494 (UMLS CUI [1,2])
C0205487 (UMLS CUI [1,3])
C0030567 (UMLS CUI [2])
C0497327 (UMLS CUI [3])
C0451306 (UMLS CUI [4])
C0033975 (UMLS CUI [5])
C0270287 (UMLS CUI [6])
C0270288 (UMLS CUI [7])
Exclusion Medical | ECG abnormality | Hypotension | Hypotension orthostatic symptomatic | Laboratory test result abnormal | Renal Insufficiency Severe
Item
other medical exclusions, like ecg abnormalities, hypotension and/or symptomatic orthostatic hypotension, some abnormal laboratory parameters (e.g. severe renal impairment), etc
boolean
C2828389 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0522055 (UMLS CUI [2])
C0020649 (UMLS CUI [3])
C0740482 (UMLS CUI [4])
C0438215 (UMLS CUI [5])
C1565489 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
Exclusion pharmacological | Selegiline | Antidepressive Agents Use Regular | Dopamine Antagonists | Pharmaceutical Preparations Dopamine Antagonists Containing
Item
pharmacological exclusions, e.g. selegiline within 8 weeks prior to screening visit, regular use of anti-depressant drugs, any medication with central dopaminergic antagonist activity, etc
boolean
C2828389 (UMLS CUI [1,1])
C0205464 (UMLS CUI [1,2])
C0036579 (UMLS CUI [2])
C0003289 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0205272 (UMLS CUI [3,3])
C0242702 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0242702 (UMLS CUI [5,2])
C0332256 (UMLS CUI [5,3])
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