A Study of MK0657 in Parkinson's Disease Patients - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00505843

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Carbidopa

U.S. FDA Resources

Further study details as provided by Merck:

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:	July 2007
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

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_524, MK0657-006
Study First Received:	July 24, 2007
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00505843 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Levodopa
Ganglion Cysts
Basal Ganglia Diseases
Carbidopa
Central Nervous System Diseases
Brain Diseases

Neurodegenerative Diseases
Dyskinesias
Dopamine
Parkinson Disease
Movement Disorders
Dopamine Agents
Parkinsonian Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Levodopa
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Carbidopa
Central Nervous System Diseases
Antiparkinson Agents

Enzyme Inhibitors
Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009