Overview

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

Status:
Completed
Trial end date:
2017-03-14
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the long-term safety of TVP-1012 (1 mg/day) in Japanese participants with early Parkinson's disease.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Takeda
Criteria
Inclusion Criteria:

- The participant has completed the preceding study.

- The participant has shown no safety issues during the study treatment in the preceding
study, in the opinion of the investigator or subinvestigator.

Exclusion Criteria:

- The participant has undergone blood collection of >= 400 mL within 90 days prior to
the start of treatment in this study.

- The participant is required to take any of the excluded medications or treatments.

- The participant is required surgery or hospitalization for surgery during the study
period.