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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00253084 |
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Date of registration:
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11/11/2005 |
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Primary sponsor: |
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Public title:
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Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease
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Scientific title:
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A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease |
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Date of first enrolment:
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November 2005 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00253084 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosed with idiopathic Parkinson's disease based on CAPIT (Core Assessment Program
for Intracerebral Transplantations) criteria.
- Currently being treated with immediate-release carbidopa-levodopa with a stable
dosing regimen over the past 4 weeks.
Exclusion Criteria:
- Diagnosed with atypical parkinsonism.
- Allergic or non-responsive to previous carbidopa-levodopa therapy.
- Active or history of narrow-angle or wide-angle glaucoma.
- History of seizure or epilepsy, or is currently taking an anti-convulsant for
treatment of seizure.
- Requires concomitant therapy with tricyclic antidepressants, MAO-B inhibitors, COMT
inhibitors or anticholinergics.
- Treatment with any neuroleptic agent, including atypical neuroleptics, within the
previous 6 months.
- Treatment with any dopaminergic blocking agent within the previous 6 months.
Age minimum:
30 Years
Age maximum:
N/A
Gender:
Both
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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: Carbidopa-Levodopa
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Drug: CD-LD ER
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Primary Outcome(s)
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"ON" time without disabling dyskinesias
[Time Frame: 2 weeks]
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Secondary Outcome(s)
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Mean time to "ON"
[Time Frame: 2 weeks]
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Mean time to "wearing OFF"
[Time Frame: 2 weeks]
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UPDRS analysis
[Time Frame: 2 weeks]
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Secondary ID(s)
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IPX054-B04-07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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