A Study of MK0657 in Parkinson's Disease Patients (0657-006)

Study Overview
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Brief Summary
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In this clinical trial, the safety of MK0657 when given with levodopa will be assessed in patients with Parkinson's Disease. This study will also measure the effectiveness of MK0657, when given in combination with levodopa, to improve motor symptoms and ameliorate dyskinesias (uncontrolled movements of a part of the body) as compared to placebo.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate Effectiveness of Single-Dose MK0657 in Combination With Levodopa on Motor Symptoms and Dyskinesias in Patients With Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: MK0657
* Drug: Comparator: Placebo (unspecified)
* Drug: Comparator: levodopa
* Drug: Comparator: carbidopa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson's Disease patients between the ages of 40 and 80 inclusive Patient is in general good health based on screening assessments Patient is willing to discontinue anti-parkinson's medications at least 8 hours prior to dosing Patient is levodopa responsive with levodopa-induced peak-dose dyskinesias Patient taking selective serotonin inhibitors (SSRIs), sleep medications and neuroleptics, have been on a stable dose for at least 30 days and has not experienced any CNS-related side effects Patient is not a heavy smoker or drinker Exclusion Criteria: Patient has atypical Parkinson's syndrome due to drugs, identified metabolic and/or neurologic disorders, encephalitis, or other degenerative syndrome Patient has known intolerance or hypersensitivity to levodopa or carbidopa Patient has been on anticholinergics or memantine within 30 days prior to dosing Patients have a history of the following: seizure disorder, stroke or head trauma, pronounced cognitive impairment, psychiatric disorder, cardiovascular disease, cancer, diabetes as defined by HbA1c of greater than 8% Patient has a systolic BP or less than 80 mm Hg or greater than 150 mm Hg

Ages Eligible for Study
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Minimum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>7mg MK0657 capsules + >/=1.0 mg/kg/hr dose of levodopa. | Drug: MK0657<br>* 7mg MK0657 capsules<br>Drug: Comparator: levodopa<br>* levodopa >/=1.0 mg/kg/hr dose of levodopa. levodopa infusions will occur over a 2 hour period<br>Drug: Comparator: carbidopa<br>* carbidopa 25mg administered 3 times: at 1 hour before levodopa infusion and at 1 and 3 hours after the start of levodopa infusion.<br>|
| Other: 2<br>7mg MK0657 Pbo capsules + >/=1.0 mg/kg/hr dose of levodopa. | Drug: Comparator: Placebo (unspecified)<br>* 7mg MK0657 Pbo capsules<br>Drug: Comparator: levodopa<br>* levodopa >/=1.0 mg/kg/hr dose of levodopa. levodopa infusions will occur over a 2 hour period<br>Drug: Comparator: carbidopa<br>* carbidopa 25mg administered 3 times: at 1 hour before levodopa infusion and at 1 and 3 hours after the start of levodopa infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy will be assessed for up to 8 hours by the Unified Parkinson's Disease Rating Scale-Motor Examination and a modified AIMS dyskinesia scale |  | 45 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability |  | 45 Days |