Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IMPAX Laboratories, Inc.; Impax Laboratories, LLC
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa

Criteria

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.