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A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Participants

Parkinson's Disease Clinical Trial

Official title:
A Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02337764
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date February 3, 2015
Completion date September 29, 2016
View Details
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