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

NCT00505843 | Completed Phase 1

• 3 other identifiers: 0657-006MK0657-0062007_524
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Safety and Tolerability

  45 Days

Study Arms (2)

1

OTHER

7mg MK0657 capsules + \>/=1.0 mg/kg/hr dose of levodopa.

Drug: MK0657; Drug: Comparator: levodopa; Drug: Comparator: carbidopa

2

OTHER

7mg MK0657 Pbo capsules + \>/=1.0 mg/kg/hr dose of levodopa.

Drug: Comparator: Placebo (unspecified); Drug: Comparator: levodopa; Drug: Comparator: carbidopa

Interventions

MK0657 DRUG

7mg MK0657 capsules

1

Comparator: Placebo (unspecified) DRUG

7mg MK0657 Pbo capsules

2

Comparator: levodopa DRUG

levodopa \>/=1.0 mg/kg/hr dose of levodopa. levodopa infusions will occur over a 2 hour period

1; 2

Comparator: carbidopa DRUG

carbidopa 25mg administered 3 times: at 1 hour before levodopa infusion and at 1 and 3 hours after the start of levodopa infusion.

1; 2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• 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.

  PMID: 19491335 RESULT

• 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.

  PMID: 29059133 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

4-methylbenzyl 3-fluoro-4-((pyrimidin-2-ylamino)methyl)piperidine-1-carboxylate

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2007
• First Posted: July 25, 2007
• Study Start: May 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: January 29, 2015

Record last verified: 2015-01