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

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet in Subjects With Parkinson's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00279825

Enrollment

Registered

2006-01-20

Start date

2006-01-31

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

Idiopathic Parkinson's Disease

Brief 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.

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 tablet containing 50 mg carbidopa and 200 mg levodopa

DRUGIPX054 250 mg

IPX054 tablet containing 62.5 mg carbidopa and 250 mg levodopa

DRUGCD-LD IR

Active comparator containing 25 mg carbidopa and 100 mg levodopa

DRUGCD-LD CR

Active comparator containing 50 mg carbidopa and 200 mg levodopa

DRUGIPX054 200 mg Placebo

Placebo to match IPX054 200 mg

DRUGIPX054 250 mg Placebo

Placebo to match IPX054 250 mg

DRUGCD-LD IR Placebo

Placebo to match CD-LD IR

DRUGCD-LD CR Placebo

Placebo to match CD-LD CR

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. * 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.

Design outcomes

Primary

Measure	Time frame
Alternate tapping of keys	single dose

Secondary

Measure	Time frame
Dyskinesia rating scale	single dose
Timed walking	single dose
Tremor score	single dose

Countries

United States

Outcome results

None listed

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