Conditions: Parkinson's Disease
Keywords: SPM 962 rotigotine Parkinson's disease
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 64
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: SPM 962 transdermal patch

Interventions: intervention 1: SPM 962
Intervention descriptions: intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day

Protocol document: