0 Ratings
ID

12098

Description

Randomized Safety Study of CVT-301 Compared to an Observational Control Group; ODM derived from: https://clinicaltrials.gov/show/NCT02352363

Link

https://clinicaltrials.gov/show/NCT02352363

Keywords

Versions (2)
  1. 9/22/15 9/22/15 - Julian Varghese
  2. 9/22/15 9/22/15 - Julian Varghese
Uploaded on

September 22, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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    Eligibility Idiopathic Parkinson's Disease NCT02352363

    English

    Eligibility Idiopathic Parkinson's Disease NCT02352363

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    has signed and dated an internal review board/independent ethics committee (irb/iec)-approved informed consent form before any protocol-specific screening procedures are performed.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hcg) test at screening. these patients must be willing to remain on their current form of contraception for the duration of the study.
    Description

    contraception; contraceptive; negative; screening; duration; protocol; current; serum; form; child; study; test; hcg

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [2]
    C1960468 (Female of child bearing age)
    SNOMED
    427504007
    UMLS CUI [3]
    C2208823 (serum human chorionic gonadotropin (hCG))
    patients who have idiopathic pd (i.e., not induced by drugs or other diseases) as defined by fulfilling steps 1 and 2 of the united kingdom (uk) brain bank criteria, diagnosed after the age of 30 years.
    Description

    united kingdom; diseases; other; brain; drugs; age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0747270 (PARKINSON IDIOPATHIC)
    patients who are classified as stage 1 to 3 (in the on state) on the modified hoehn and yahr scale for staging of pd severity.
    Description

    severity; staging; stage; state

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3639483 (MDS-UPDRS - Hoehn and Yahr Stage)
    patients who have experienced motor fluctuations for a minimum of 2 hours of average daily off time per waking day (excluding early morning off time) by self-report and confirmed by the pd diary (on 3 consecutive days) during the screening period.
    Description

    screening; confirmed; daily; motor; time; self; day; per

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1868976 (Motor fluctuations)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
    Description

    procedure(s); procedures; severity; study

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013384 (Dyskinetic syndrome)
    SNOMED
    9748009
    UMLS CUI [1,2]
    C0439793 (Severities)
    SNOMED
    272141005
    pregnant or lactating females or females wishing to become pregnant.
    Description

    pregnant or lactating females

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2828358 (Lactating (finding))
    UMLS CUI [2]
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    patients who have any known contraindication to the use of levodopa (ld), including a history of malignant melanoma or a history of narrow-angle glaucoma.
    Description

    malignant melanoma; glaucoma; levodopa

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023570 (levodopa)
    SNOMED
    15383004
    UMLS CUI [1,2]
    C0522473 (Contraindication)
    SNOMED
    103306004
    UMLS CUI [2]
    C0025202 (melanoma)
    SNOMED
    2092003
    UMLS CUI [3]
    C0017605 (Angle Closure Glaucoma)
    SNOMED
    392291006
    patients who have had previous surgery for pd (including but not limited to deep brain stimulation [dbs] or cell transplantation).
    Description

    transplantation; not limited; surgery; brain

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0038894 (Surgery specialty)
    UMLS CUI [1,2]
    C0030567 (Parkinson Disease)
    SNOMED
    49049000
    patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months (stable regimens [for at least 4 weeks prior to screening visit 1 (sv1)] of anti-depressant and certain low-dose atypical antipsychotic medications are permitted).
    Description

    anti-depressant; medications; treatment; screening; symptoms; suicide; stable; visit; dose; low

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0871189 (Psychotic symptom)
    SNOMED
    363895008
    UMLS CUI [2]
    C1821181 (Suicide ideation)
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    Similar models

    Eligibility Idiopathic Parkinson's Disease NCT02352363

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    has signed and dated an internal review board/independent ethics committee (irb/iec)-approved informed consent form before any protocol-specific screening procedures are performed.
    boolean
    C0021430 (UMLS CUI [1])
    contraception; contraceptive; negative; screening; duration; protocol; current; serum; form; child; study; test; hcg
    Item
    women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hcg) test at screening. these patients must be willing to remain on their current form of contraception for the duration of the study.
    boolean
    C0700589 (UMLS CUI [1])
    C1960468 (UMLS CUI [2])
    C2208823 (UMLS CUI [3])
    united kingdom; diseases; other; brain; drugs; age
    Item
    patients who have idiopathic pd (i.e., not induced by drugs or other diseases) as defined by fulfilling steps 1 and 2 of the united kingdom (uk) brain bank criteria, diagnosed after the age of 30 years.
    boolean
    C0747270 (UMLS CUI [1])
    severity; staging; stage; state
    Item
    patients who are classified as stage 1 to 3 (in the on state) on the modified hoehn and yahr scale for staging of pd severity.
    boolean
    C3639483 (UMLS CUI [1])
    screening; confirmed; daily; motor; time; self; day; per
    Item
    patients who have experienced motor fluctuations for a minimum of 2 hours of average daily off time per waking day (excluding early morning off time) by self-report and confirmed by the pd diary (on 3 consecutive days) during the screening period.
    boolean
    C1868976 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    procedure(s); procedures; severity; study
    Item
    patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
    boolean
    C0013384 (UMLS CUI [1,1])
    C0439793 (UMLS CUI [1,2])
    pregnant or lactating females
    Item
    pregnant or lactating females or females wishing to become pregnant.
    boolean
    C2828358 (UMLS CUI [1])
    C0549206 (UMLS CUI [2])
    malignant melanoma; glaucoma; levodopa
    Item
    patients who have any known contraindication to the use of levodopa (ld), including a history of malignant melanoma or a history of narrow-angle glaucoma.
    boolean
    C0023570 (UMLS CUI [1,1])
    C0522473 (UMLS CUI [1,2])
    C0025202 (UMLS CUI [2])
    C0017605 (UMLS CUI [3])
    transplantation; not limited; surgery; brain
    Item
    patients who have had previous surgery for pd (including but not limited to deep brain stimulation [dbs] or cell transplantation).
    boolean
    C0038894 (UMLS CUI [1,1])
    C0030567 (UMLS CUI [1,2])
    anti-depressant; medications; treatment; screening; symptoms; suicide; stable; visit; dose; low
    Item
    patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months (stable regimens [for at least 4 weeks prior to screening visit 1 (sv1)] of anti-depressant and certain low-dose atypical antipsychotic medications are permitted).
    boolean
    C0871189 (UMLS CUI [1])
    C1821181 (UMLS CUI [2])
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