A Study of MK0657 in Parkinson's Disease Patients (0657-006)
NCT ID: NCT00505843
Last Updated: 2015-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2007-05-31
2008-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500
NCT01058291
A Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of NCR201 in the Treatment of Subjects With Parkinson's Disease
NCT06978920
A Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects with Early Parkinson's Disease
NCT06175767
A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease
NCT05036473
12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/Carbidopa
NCT00456586
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
7mg MK0657 capsules + \>/=1.0 mg/kg/hr dose of levodopa.
MK0657
7mg MK0657 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.
2
7mg MK0657 Pbo capsules + \>/=1.0 mg/kg/hr dose of levodopa.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MK0657-006
Identifier Type: -
Identifier Source: secondary_id
2007_524
Identifier Type: -
Identifier Source: secondary_id
0657-006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.