This study will evaluate the effects of an experimental drug called ACP-103 on Parkinson's
disease symptoms and on dyskinesias (involuntary movements) that develop as a result of
long-term levodopa treatment. ACP-103 changes the spread of certain brain signals that are
affected in patients with Parkinson's disease.
Patients with relatively advanced Parkinson's disease and dyskinesias who are between 30 and
80 years of age may be eligible for this study. Candidates are screened with a complete
medical history and physical examination, neurological evaluation, blood and urine tests, and
electrocardiogram (ECG). A brain magnetic resonance imaging (MRI) scan, CT scan, and chest
x-ray may be done if medically indicated.
Patients enrolled in the study will, if possible, stop taking all antiparkinsonian
medications for one month (2 months for Selegiline) before the study begins and throughout
its duration. Exceptions are Sinemet (levodopa/carbidopa), Mirapex (pramipexole) and Requip
(ropinirole).
Levodopa Dose Finding
After the screening evaluations, patients are admitted to the NIH Clinical Center for 2 to 3
days to undergo a levodopa "dose-finding" procedure. For this test, patients stop taking
Sinemet and instead have levodopa infused through a vein. During the infusion, the drug dose
is increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side
effects occur, or 3) the maximum study dose is reached. Side effects are monitored closely
during the infusions, and parkinsonian symptoms are evaluated frequently during and after the
infusions. The infusions usually begin early in the morning and continue until evening. Once
the infusion is finished, patients resume taking their regular oral Sinemet dose. The
infusions are repeated once a week during 1-day inpatient evaluations.
Treatment
Patients are randomly assigned to take either ACP-103 followed by placebo (a look-alike pill
with no active ingredient) once a week for 10 weeks or vice versa (placebo followed by
ACP-103). Patients are admitted to the Clinical Center for each dose. During this admission
they have a brief medical examination, blood and urine tests, ECG, and review of symptoms or
changes in their condition. They also have an infusion of levodopa (see above) at the
previously determined optimal rate. Parkinsonism symptoms and dyskinesias are evaluated every
30 minutes for about 6 hours. At the end of the infusions and ratings, patients are
discharged home with their regular Parkinson's medications until the following visit.
Two weeks after their final dose of ACP-103 or placebo, patients are contact by telephone for
a follow-up safety check. At that time, the investigator may ask the patient to return to the
clinic for closer evaluation.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)