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

Parkinson's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00505843
• Other study ID #: 0657-006
• Secondary ID: MK0657-0062007_5
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2007
• Last updated: January 28, 2015
• Start date: May 2007
• Est. completion date: February 2008

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• MK0657
7mg MK0657 capsules
• Comparator: Placebo (unspecified)
7mg MK0657 Pbo capsules
• Comparator: levodopa
levodopa >/=1.0 mg/kg/hr dose of levodopa. levodopa infusions will occur over a 2 hour period
• Comparator: carbidopa
carbidopa 25mg administered 3 times: at 1 hour before levodopa infusion and at 1 and 3 hours after the start of levodopa infusion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Addy C, Assaid C, Hreniuk D, Stroh M, Xu Y, Herring WJ, Ellenbogen A, Jinnah HA, Kirby L, Leibowitz MT, Stewart RM, Tarsy D, Tetrud J, Stoch SA, Gottesdiener K, Wagner J. Single-dose administration of MK-0657, an NR2B-selective NMDA antagonist, does not r — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety and Tolerability		45 Days	Yes