Conditions: Parkinson's Disease
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 222
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate long-term safety of TVP-1012 (1 mg/day) with levodopa in Japanese participants with Parkinson's disease.

Detailed description:
This is a multicenter, open-label, long-term, phase 3 study to evaluate the safety and efficacy of long-term administration of TVP-1012 at 1 mg with levodopa in Japanese participants with Parkinson's disease.

The study period consisted of a 2-week run-in period and a subsequent 52-week treatment period. Participants fulfilling the inclusion criteria and did not meet any of the exclusion criteria at the start of the run-in period (Week -2) and also at the end of the run-in period (Week 0) were enrolled in the study, and received 1 mg of TVP-1012 once daily for 52 weeks, in an unblinded manner, from the day after Week 0.

Arms:
arm 1: TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet for 52 weeks as treatment period after 2 weeks of run-in period.

Interventions: intervention 1: TVP-1012 1mg
Intervention descriptions: intervention 1: TVP-1012 1mg Tablets

Protocol document: