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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00758368 |
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Date of registration:
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23/09/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of Continuous and Pulsatile Apomorphine in Parkinson's Disease
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Scientific title:
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Comparison of Continuous and Pulsatile Apomorphine Administration in Parkinson's Disease Complicated by Levodopa-induced Dyskinesia |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT00758368 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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John G. Nutt, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oregon Health and Science University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- idiopathic Parkinson's Disease
- clear response to levodopa (sinemet)
- "off" at least 20% of waking day
- dyskinesias present for at least two hours of waking day
- subject or caregiver able to master use of drug delivery system (injector pen or pump)
Exclusion Criteria:
- physical complications that would preclude safe participation
- standing systolic BP of <80
- lack of tolerance or response to apomorphine
- drug/alcohol abuse
Age minimum:
21 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Apomorphine
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Primary Outcome(s)
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Change in dyskinesia severity and duration during the levodopa infusion, measured with a clinical rating scale during two-hour levodopa infusion
[Time Frame: at baseline and after 6 months]
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Secondary Outcome(s)
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Improvement in "on" time, as measured by subject diaries
[Time Frame: at baseline and after 6 months]
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Improvement in motor performance, measured as change in tapping speed during levodopa infusion
[Time Frame: at baseline and after 6 months]
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Reduction in levodopa and adjunct drug use
[Time Frame: at baseline and after 6 months]
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Secondary ID(s)
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eIRB 2167
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R01NS021062-21
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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