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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00505843
First received: July 24, 2007
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: MK0657
Drug: Comparator: Placebo (unspecified)
Drug: Comparator: levodopa
Drug: Comparator: carbidopa
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 45 Days ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
7mg MK0657 capsules + >/=1.0 mg/kg/hr dose of levodopa.
Drug: MK0657
7mg MK0657 capsules
Drug: Comparator: levodopa
levodopa >/=1.0 mg/kg/hr dose of levodopa. levodopa infusions will occur over a 2 hour period
Drug: 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.
2
7mg MK0657 Pbo capsules + >/=1.0 mg/kg/hr dose of levodopa.
Drug: Comparator: Placebo (unspecified)
7mg MK0657 Pbo capsules
Drug: Comparator: levodopa
levodopa >/=1.0 mg/kg/hr dose of levodopa. levodopa infusions will occur over a 2 hour period
Drug: 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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505843

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00505843     History of Changes
Other Study ID Numbers: 0657-006, MK0657-006, 2007_524
Study First Received: July 24, 2007
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014