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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: IPX054 200 mg
* Drug: CD-LD IR
* Drug: IPX054 Placebo
* Drug: CD-LD IR Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IPX054 - CD-LD IR<br>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. | Drug: IPX054 200 mg<br>* IPX054 containing 50 mg carbidopa and 200 mg levodopa<br>* Other names: CD-LD ER 200 mg;Drug: CD-LD IR<br>* CD-LD IR containing 25 mg carbidopa and 100 mg levodopa<br>Drug: IPX054 Placebo<br>* Placebo to match IPX054 200 mg<br>Drug: CD-LD IR Placebo<br>* Placebo to match CD-LD IR<br>|
| Other: CD-LD IR - IPX054<br>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. | Drug: IPX054 200 mg<br>* IPX054 containing 50 mg carbidopa and 200 mg levodopa<br>* Other names: CD-LD ER 200 mg;Drug: CD-LD IR<br>* CD-LD IR containing 25 mg carbidopa and 100 mg levodopa<br>Drug: IPX054 Placebo<br>* Placebo to match IPX054 200 mg<br>Drug: CD-LD IR Placebo<br>* Placebo to match CD-LD IR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ON time without disabling dyskinesias |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS analysis |  | 2 weeks | 
| Mean time to ON |  | 2 weeks | 
| Mean time to wearing OFF |  | 2 weeks |