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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00253084

Enrollment

Registered

2005-11-15

Start date

2005-11-30

Completion date

2007-12-31

Last updated

2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

Interventions

DRUGIPX054 200 mg

IPX054 containing 50 mg carbidopa and 200 mg levodopa

DRUGCD-LD IR

CD-LD IR containing 25 mg carbidopa and 100 mg levodopa

DRUGIPX054 Placebo

Placebo to match IPX054 200 mg

DRUGCD-LD IR Placebo

Placebo to match CD-LD IR

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
ON time without disabling dyskinesias	2 weeks

Secondary

Measure	Time frame
UPDRS analysis	2 weeks
Mean time to ON	2 weeks
Mean time to wearing OFF	2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026