0 Beoordelingen
ID

43686

Beschrijving

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

Trefwoorden

Versies (2)
  1. 20-11-16 20-11-16 -
  2. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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    Eligibility Parkinson Disease NCT00148512

    Engels

    Eligibility Parkinson Disease NCT00148512

    1 Formulieren  
    Criteria
    Beschrijving

    Criteria

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

    Gender | Parkinson Disease

    Datatype

    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.
    Beschrijving

    Age

    Datatype

    boolean

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

    UPDRS - Modified Hoehn and Yahr Staging

    Datatype

    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.
    Beschrijving

    Levodopa Dose times/day Stable

    Datatype

    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.
    Beschrijving

    Motor fluctuations Duration Daily

    Datatype

    boolean

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

    Exclusion Criteria Main

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Terug naar het begin van de pagina

    Similar models

    Eligibility Parkinson Disease NCT00148512

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    Terug naar het begin van de pagina 

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