This study will evaluate the effects of an experimental drug called KW-6002 on Parkinson's
disease symptoms and on dyskinesias (involuntary movements) that develop as a result of
long-term treatment with levodopa. This drug blocks the action of the neurotransmitter
adenosine, thought to be involved in producing Parkinson's symptoms.
Patients with relatively advanced (Stage II to IV) Parkinson's disease between 30 and 80
years of age may be eligible for this 7-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 enrolled in the study will, if possible, stop taking all antiparkinsonian
medications except levodopa (Sinemet) for one month before the study begins and throughout
its duration. For the first 1 to 3 days, patients will be admitted to the NIH Clinical center
to undergo a levodopa "dose-finding" procedure. For this study, patients will stop taking
Sinemet and instead will have levodopa infused through a vein for up to 8 hours/day. During
the infusions, the drug dose will be increased slowly until either 1) parkinsonian symptoms
improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached.
Symptoms will be monitored frequently to find two infusion rates: 1) one that is less than
what is needed to relieve symptoms, and 2) one that relieves symptoms but may produce
dyskinesias. This procedure will be repeated at the end of weeks 2, 4 and 6 of the study.
When the patient's optimal dose is determined treatment will begin. Patients will take
tablets or capsules containing KW-6002 or placebo (a look-alike pill with no active
ingredient) once a day for 2 weeks, in addition to their regular Sinemet. All participants
will receive placebo at least 2 weeks during the study; some patients will receive only
placebo throughout the entire 7 weeks. At the end of weeks 1, 3 and 5, patients will be
evaluated with a brief physical examination, routine blood and urine tests, and assessment of
any adverse effects.
Throughout the study, parkinsonian 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)