Back to resultsA Study of MK0657 in Parkinson's Disease Patients (0657-006)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK0657
Comparator: Placebo (unspecified)
Comparator: levodopa
Comparator: carbidopa
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
7mg MK0657 capsules + >/=1.0 mg/kg/hr dose of levodopa.
7mg MK0657 Pbo capsules + >/=1.0 mg/kg/hr dose of levodopa.
Outcomes
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
Secondary Outcome Measures
Safety and Tolerability
Full Information
NCT ID
NCT00505843
First Posted
July 24, 2007
Last Updated
January 28, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00505843
Brief Title
A Study of MK0657 in Parkinson's Disease Patients (0657-006)
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
7mg MK0657 capsules + >/=1.0 mg/kg/hr dose of levodopa.
Arm Title
2
Arm Type
Other
Arm Description
7mg MK0657 Pbo capsules + >/=1.0 mg/kg/hr dose of levodopa.
Intervention Type
Drug
Intervention Name(s)
MK0657
Intervention Description
7mg MK0657 capsules
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo (unspecified)
Intervention Description
7mg MK0657 Pbo capsules
Intervention Type
Drug
Intervention Name(s)
Comparator: levodopa
Intervention Description
levodopa >/=1.0 mg/kg/hr dose of levodopa. levodopa infusions will occur over a 2 hour period
Intervention Type
Drug
Intervention Name(s)
Comparator: carbidopa
Intervention Description
carbidopa 25mg administered 3 times: at 1 hour before levodopa infusion and at 1 and 3 hours after the start of levodopa infusion.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Safety and Tolerability
Time Frame
45 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19491335
Citation
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 result in clinically meaningful improvement in motor function in patients with moderate Parkinson's disease. J Clin Pharmacol. 2009 Jul;49(7):856-64. doi: 10.1177/0091270009336735. Epub 2009 Jun 2.
Results Reference
result
PubMed Identifier
29059133
Citation
Herring WJ, Assaid C, Budd K, Vargo R, Mazenko RS, Lines C, Ellenbogen A, Verhagen Metman L. A Phase Ib Randomized Controlled Study to Evaluate the Effectiveness of a Single-Dose of the NR2B Selective N-Methyl-D-Aspartate Antagonist MK-0657 on Levodopa-Induced Dyskinesias and Motor Symptoms in Patients With Parkinson Disease. Clin Neuropharmacol. 2017 Nov/Dec;40(6):255-260. doi: 10.1097/WNF.0000000000000241.
Results Reference
derived
Learn more about this trial
A Study of MK0657 in Parkinson's Disease Patients (0657-006)
We'll reach out to this number within 24 hrs