A Dose-ranging Study for SPM 962 in Parkinson's Disease Patients
Status:
Completed
Trial end date:
2006-05-01
Target enrollment:
Participant gender:
Summary
The primary objective of this trial is to establish the maximum maintenance dose of SPM 962
in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by
conducting safety evaluation of each patient following once-daily transdermal doses of SPM
962 within a range of 4.5 to 36.0 mg. (The administration period will consist of a standard
8-week dose-titration period, 4-week dose-maintenance period, and a dose de-escalation
period) Exploratory evaluation of each patient's maintenance dose will also be conducted with
attention to patient safety. The relationship of pharmacokinetics, safety, and efficacy will
also be examined.