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| ID | Type | Description | Link |
|---|---|---|---|
| MK0657-006 | |||
| 2007_524 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | 7mg MK0657 capsules + >/=1.0 mg/kg/hr dose of levodopa. |
|
| 2 | Other | 7mg MK0657 Pbo capsules + >/=1.0 mg/kg/hr dose of levodopa. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0657 | Drug | 7mg MK0657 capsules |
| |
| Comparator: Placebo (unspecified) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | 45 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19491335 | Result | 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. | |
| 29059133 |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C576352 | 4-methylbenzyl 3-fluoro-4-((pyrimidin-2-ylamino)methyl)piperidine-1-carboxylate |
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| Drug |
7mg MK0657 Pbo capsules |
|
| Comparator: levodopa | Drug | levodopa >/=1.0 mg/kg/hr dose of levodopa. levodopa infusions will occur over a 2 hour period |
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| 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. |
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| Derived |
| 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |