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

Takeda

Status and phase

Completed

Phase 3

Conditions

Parkinson's Disease

Treatments

Drug: TVP-1012 1mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02337751

TVP-1012/OCT-001

JapicCTI-152761 (Registry Identifier)

U1111-1165-1437 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

This is a multicenter, open-label, long-term, extension, phase 3 study to evaluate the safety and efficacy of long-term administration of TVP-1012 at 1 mg for another 26 weeks in participants with early Parkinson's disease who have completed the preceding TVP-1012/CCT-001 (NCT02337725) study.

Among participants of the TVP-1012/CCT-001 study, those consenting to participate in this study prior to complete the preceding study and fulfilling the eligibility criteria will be enrolled in this study. From the day after the Visit 8 of the preceding study, participants will receive 1 mg of TVP-1012 once daily for 26 weeks in an unblinded manner.

Enrollment

198 patients

Sex

All

Ages

30 to 79 years old

Volunteers

No Healthy Volunteers

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.