Conditions: Parkinson's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 420
Healthy volunteers: no

Brief summary:
* To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in order to confirm clinical value of SPM 962.
* To demonstrate the superiority of SPM 962 to placebo in terms of efficacy.
* To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.

Detailed description:

Arms:
arm 1: SPM 962 transdermal patch arm 2: Ropinirole tablet arm 3: SPM962 placebo patch and Ropinirole placebo tab

Interventions: intervention 1: SPM 962 intervention 2: Ropinirole intervention 3: Placebo
Intervention descriptions: intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day intervention 2: Ropinirole oral administration TID up to 15.0 mg/day intervention 3: SPM962-placebo patch and Ropinirole-placebo tab

Protocol document: