Study of LY300164 for the Treatment of Parkinson's Disease
Status:
Completed
Trial end date:
2000-08-01
Target enrollment:
Participant gender:
Summary
This study will test the effectiveness of an experimental drug called LY300164 on improving
Parkinson's disease symptoms, such as movement impairments and tremor, as well as involuntary
movements produced by long-term treatment with levodopa.
Patients with relatively advanced (Stage II to IV) Parkinson's disease between 30 and 75
years of age may be eligible for this 8-week study. Participants will have a complete medical
history and physical examination, including blood tests and an electrocardiogram, and
possibly brain magnetic resonance imaging (MRI), CT scan, and chest X-ray.
Patients will stop taking all anti-parkinsonism medications except levodopa (Sinemet) and the
experimental drug during the study. For the first 1 to 3 days, patients will be in the
hospital for a levodopa "dose-finding" procedure. For this study, levodopa is infused through
a vein for up to 8 hours, with symptoms monitored frequently to determine the doses that will
produce two results: 1) the dose that is less than what is needed to relieve symptoms, and 2)
the dose that relieves symptoms, but may produce dyskinesias.
When these dose rates are determined, patients will begin treatment in one of two groups. One
will take LY300164 3 times a day, along with levodopa, for 3 weeks. The second group will
take placebo tablets (a look-alike tablet with no active ingredient) and levodopa on the same
schedule as the LY300164 group. A brief medical examination and routine blood and urine tests
will be done weekly. The drug dose will be increased every 3 to 4 days until significant side
effects occur or the maximal dose is reached. Patients will be closely monitored for 4 hours
after every increase. At the end of the 3 weeks, or when the maximal dose is reached,
patients will be readmitted to the hospital for 2 to 3 days for a second levodopa
dose-finding study, while continuing on LY300164 or placebo. After this test, patients will
resume taking levodopa and the experimental drug or placebo as before for another 2 weeks.
At the end of the 2-weeks, the entire procedure will be repeated in both groups, but the
treatments will be switched-that is, the patients who were taking LY300164 will now take
placebo, and the patients who took placebo will now take the drug. At the end of the second 3
weeks, the levodopa infusion procedure will be repeated once more.
Throughout the study, parkinsonism symptoms and dyskinesias will be evaluated and blood
samples will be drawn periodically to measure drug levels.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)