Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease

Condition(s) targeted: Parkinson's Disease

Intervention: IPX054 (Drug); Carbidopa-Levodopa (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: IMPAX Laboratories, Inc.

The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release carbidopa-levodopa in subjects with Parkinson's disease.

Official title: A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease

Study design: Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study

Primary outcome: "ON" time without disabling dyskinesias

Secondary outcome:

UPDRS analysis

Mean time to "ON"

Mean time to "wearing OFF"

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Rush University Medical Center, Chicago, Illinois 60612, United States; Recruiting
Lucia Blasucci, Phone: 312-563-2900, Email: lucia_m_blasucci@rush.edu
Christopher Goetz, MD, Principal Investigator

Starting date: November 2005
Last updated: November 11, 2005