Conditions: Parkinson's Disease
Keywords: SPM 962 rotigotine Parkinson's disease concomitant use of L-dopa
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 174
Healthy volunteers: no

Brief summary:
The primary objective of this study is to investigate efficacy and safety of SPM 962 in advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also to be investigated with distribution of the maintenance dose and accumulated response rate of efficacy.

Detailed description:

Arms:
arm 1: SPM 962 transdermal patch arm 2: Placebo transdermal patch

Interventions: intervention 1: SPM 962 intervention 2: Placebo
Intervention descriptions: intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day intervention 2: Placebo transdermal patch

Protocol document: