Phase I Trial of a New Medication for Parkinson's Disease
Title: A randomized, double-blind, placebo-controlled, 3-period crossover study to evaluate improvement in motor symptoms as assessed by the Unified Parkinson's Disease Rating Scale Motor Examination (UPDRS-ME) in male and female patients with moderate Parkinson's disease after single dose administration of L-001067743, Sinemet® 25/250 mg, or placebo
Investigator: This study is being conducted by Merck & Co., Inc.
Site Principal Investigator: Dr. Helen Bronte-Stewart at Stanford University, in conjunction with Dr. James Tetrud at the Parkinson's Institute, Sunnyvale, CA.
Disease/Condition under Investigation: Parkinson's disease
Purpose: To evaluate the single-dose efficacy and safety/tolerability of L-001067743 7mg in male and female patients with moderate Parkinson's disease as assessed by the UPDRS-ME.
Treatments: L-001067743 7mg, Sinemet® 25/250 mg, placebo
- male or female between 50-70 years of age
- have been clinically diagnosed with idiopathic Parkinson's disease
- have been on a stable dose of levodopa for at least 4 weeks prior to study
- does not smoke or use any other nicotine-containing products
- a diagnosis of secondary or atypical parkinsonism
- patient has known intolerance to or hypersensitivity to levodopa or carbidopa or to any ingredients in Sinemet®
- patient has dyskinesia or episodes of 'freezing'
- patient had surgery, donated blood or participated in another clinical study using investigational drugs within 4 weeks prior to screening