Effects of Monoamine Reuptake Inhibitor NS2330 in Parkinson's Disease
Status:
Completed
Trial end date:
2003-07-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the effects of an experimental drug called NS2330 on Parkinson's
disease symptoms and on dyskinesias (involuntary movements) that develop as a result of
long-term treatment with levodopa. This drug prevents the neurotransmitter dopamine from
entering nerve cells.
Patients between 18 and 75 years old who have moderately advanced Parkinson's disease and
motor problems resulting from levodopa therapy may be eligible for this 5-week study.
Candidates will have a complete medical history and physical examination with a detailed
neurological evaluation. If needed, some patients will undergo a magnetic resonance imaging
(MRI) or computerized tomography (CT) scan of the brain and a chest X-ray. All patients will
have blood and urine tests and an electrocardiogram (EKG) and will take a written test for
evaluation of depression.
Patients enrolled in the study will, if possible, stop taking all antiparkinson medications
except levodopa (Sinemet) for one month before the study begins and through its duration. For
the first 1 to 3 days, patients will undergo a levodopa "dose-finding" procedure. For this
study, patients will stop taking their usual oral levodopa medicine and instead will have
levodopa infused through a vein for up to 12 hours. During the infusions, the drug dose will
be increased slowly until either 1) parkinsonism symptoms improve, 2) dyskinesias appear, 3)
unacceptable side effects occur, or 4) the maximum study dose is reached.
When the patient's optimal dose is determined, treatment will begin. Patients will take three
pills containing NS2330 or placebo (a look-alike pill with no active ingredient) 3 days a
week for up to 5 weeks, in addition to their regular levodopa medication. All participants
will receive placebo at some point in the study; some patients will receive only placebo
throughout the entire 5 weeks.
On treatment days, patients will have a brief medical examination before receiving the drug
and will then be monitored for side effects for about 6 to 8 hours after taking the drug. At
the beginning of weeks 2 and 5, the levodopa infusions will be repeated at the previously
determined optimum rate. Throughout the study, parkinsonism symptoms, dyskinesias and
depression will be evaluated. Blood and urine samples will be collected each week for
standard safety tests, and blood will also be drawn periodically to measure NS2330 levels.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)