Parcopa Versus Carbidopa-levodopa in a Single Dose Cross-over Comparison Study

Study Overview
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Brief Summary
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To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.

Detailed Description
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This is a study to compare orally dissolving levodopa (Parcopa) to the conventional immediate release oral levodopa. This is a single-dose, double-blind, placebo controlled crossover trial in participants with Parkinson disease.

Official Title
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Comparison of Orally Dissolving Carbidopa/Levodopa (Parcopa) to Conventional Oral Carbidopa/Levodopa: A Single-Dose, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover Trial

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Parcopa
* Drug: carbidopa-levodopa (Sinemet)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between the age of 31 and 80 -Diagnosis of idiopathic Parkinson's disease for at least three years duration Patients requiring levodopa for their PD Good subjective response to levodopa Fluctuating symptoms defined by wearing off phenomenon, any dyskinesia, and/or dose failures A UPDRS -off- motor score of at least 25 Subjects willing to give informed consent Subjects who are able and willing to comply with study procedures If female of child-bearing potential, will use one of the approved birth control measures: Hormonal contraceptives Spermicidal and barrier Intrauterine device Partner sterility Exclusion Criteria: Subjects with evidence of significant dementia Subjects with significant oral lesions History of unstable cardiac disease including angina or congestive heart failure within 3 months prior to study entry History of clinically significant renal disease including renal insufficiency of sufficient degree to require adjunctive treatment or dietary restrictions History of clinically significant hepatic disease, including previously documented cirrhosis or hepatic insufficiency or jaundice within 3 months prior to study entry. Subjects with poor response to levodopa Women who are pregnant, breast-feeding, or planning to become pregnant during this study are excluded from participation due to unknown effects of the study drug on the fetus.

Ages Eligible for Study
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Minimum Age: 31 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomization Group b<br>Parcopa at equivalent dosage to subjects current stable dose | Drug: Parcopa<br>* at subjects current stable dose of comparator<br>|
| Active Comparator: Randomization Group a<br>Carbidopa-levodopa (Sinemet)at subjects current stable dose | Drug: carbidopa-levodopa (Sinemet)<br>* at subjects current stable dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Time in Minutes From When a Patient Was in a Clinical Off State, Took Their Medication and Went Into a Clinical on State | Time to on state (benefit with regard to mobility, stiffness and slowness) with parcopa versus carbidopa/levodopa immediate release compound. This measurement is compared between Parcopa and carbidopa/levodopa wit the first morning dose of each intervention. Study duration was 2 days. | first dose of day for each arm | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, time to on, delayed on