Parkinson's Disease
Conditions
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.
Interventions
DRUGMK0657
7mg MK0657 capsules
DRUGComparator: Placebo (unspecified)
7mg MK0657 Pbo capsules
DRUGComparator: levodopa
levodopa \>/=1.0 mg/kg/hr dose of levodopa. levodopa infusions will occur over a 2 hour period
DRUGComparator: carbidopa
carbidopa 25mg administered 3 times: at 1 hour before levodopa infusion and at 1 and 3 hours after the start of levodopa infusion.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability | 45 Days |
Outcome results
None listed