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

Phase 2

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: IPX054 200 mg; Drug: CD-LD IR; Drug: IPX054 Placebo; Drug: CD-LD IR Placebo

• Registration Number: NCT00253084
• Lead Sponsor: Impax Laboratories, LLC

Brief Summary

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

Detailed Description

IPX054 contains two different drugs called levodopa and carbidopa in one tablet.

* levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.

* carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-11
• Study First Submitted QC: 2005-11-11
• Study First Posted: 2005-11-15
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2017-01
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IPX054 - CD-LD IR	IPX054 200 mg	Subjects received IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks and then received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks.
IPX054 - CD-LD IR	CD-LD IR	Subjects received IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks and then received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks.
IPX054 - CD-LD IR	IPX054 Placebo	Subjects received IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks and then received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks.
IPX054 - CD-LD IR	CD-LD IR Placebo	Subjects received IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks and then received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks.
CD-LD IR - IPX054	IPX054 200 mg	Subjects received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks and then IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks.
CD-LD IR - IPX054	CD-LD IR	Subjects received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks and then IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks.
CD-LD IR - IPX054	IPX054 Placebo	Subjects received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks and then IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks.
CD-LD IR - IPX054	CD-LD IR Placebo	Subjects received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks and then IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks.

Primary Outcome Measures

Name	Time	Method
"ON" time without disabling dyskinesias	2 weeks

Secondary Outcome Measures

Name	Time	Method
UPDRS analysis	2 weeks
Mean time to "ON"	2 weeks
Mean time to "wearing OFF"	2 weeks

Trial Locations

Locations (2)

Site 1; 🇺🇸 Chicago, Illinois, United States

Site 2; 🇺🇸 Charleston, South Carolina, United States