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OpenTrials
Completed

NCT Number: NCT00505843

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0657

Drug

7mg MK0657 capsules

Comparator: Placebo (Unspecified)

Drug

7mg MK0657 Pbo capsules

Comparator: levodopa

Drug

levodopa >/=1.0 mg/kg/hr dose of levodopa. levodopa infusions will occur over a 2 hour period

Comparator: carbidopa

Drug

carbidopa 25mg administered 3 times: at 1 hour before levodopa infusion and at 1 and 3 hours after the start of levodopa infusion.

Primary outcomes

  1. 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

    Time frame: 45 Days

Secondary outcomes

  1. Safety and Tolerability

    Time frame: 45 Days

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 25, 2007
Registry last updated
Jan 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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