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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253084
• Other study ID #: IPX054-B04-07
• Status: Completed
• Phase: Phase 2
• Start date: November 2005
• Est. completion date: December 2007

Study information

• Verified date: January 2017
• Source: Impax Laboratories, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• IPX054 200 mg
IPX054 containing 50 mg carbidopa and 200 mg levodopa
• CD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
• IPX054 Placebo
Placebo to match IPX054 200 mg
• CD-LD IR Placebo
Placebo to match CD-LD IR

Locations

Country	Name	City	State
United States	Site 2	Charleston	South Carolina
United States	Site 1	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Impax Laboratories, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"ON" time without disabling dyskinesias		2 weeks
Secondary	UPDRS analysis		2 weeks
Secondary	Mean time to "ON"		2 weeks
Secondary	Mean time to "wearing OFF"		2 weeks