Comparison of IPX054, Immediate-Release Carbidopa-Levodopa, and Controlled-Release Carbidopa-Levodopa in Subjects With Parkinson's Disease
The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic Parkinson's disease...
Brief Summary
Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to Carbidopa-Levodopa Immediate-Release 200 (2x100) mg Tablets and Carbidopa-Levodopa Controlled-Release 200 mg Tablet in Subjects With Parkinson's Disease”
The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic Parkinson's disease.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: December 2007
Intervention(s) in this Clinical Trial
- Drug: IPX054
- IPX054 200 mg
- Drug: Carbidopa-levodopa immediate-release tablets
- IPX054 250 mg
- Drug: CD-LD IR
- 200 mg
- Drug: CD-LD ER
- 200 mg
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- IPX054 200 mg
- Experimental: 2
- IPX054 250 mg
- Active Comparator: 3
- CD-LD IR
- Active Comparator: 4
- CD-LD ER
Outcome Measures for this Clinical Trial
Primary Measures
- Alternate tapping of keys
- Time Frame: single dose
Safety Issue?: No
- Time Frame: single dose
Secondary Measures
- Timed walking
- Time Frame: single dose
Safety Issue?: No
- Time Frame: single dose
- Tremor score
- Time Frame: single dose
Safety Issue?: No
- Time Frame: single dose
- Dyskinesia rating scale
- Time Frame: single dose
Safety Issue?: No
- Time Frame: single dose
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Diagnosed with idiopathic Parkinson's disease.
- Currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
- Must experience "wearing OFF" between doses of medication.
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 seizures.
- Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.
- Treatment with any dopaminergic blocking agent within the previous 3 months.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: IMPAX Laboratories, Inc. Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00279825
Study ID Number: IPX054-B05-01
ClinicalTrials.gov Identifier: NCT00279825
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00279825
