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

Phase 3

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: TVP-1012 1mg

• Registration Number: NCT02337751
• Lead Sponsor: Takeda

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-14
• Study Start: 2015-07-10
• Primary Completion: 2017-03-14
• Study Completion: 2017-03-14
• Results First Submitted: 2018-02-25
• Results First Submitted QC: 2018-10-23
• Results First Posted: 2019-02-28
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TVP-1012 1mg Group	TVP-1012 1mg	TVP-1012 (1 mg/day) once daily, either before or after breakfast.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)	Up to 52 weeks	Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score	Baseline to End of treatment (Week 52)	MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II+III Total Score was 0-188, with the higher score reflecting the greater severity. Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).
Number of Participants With TEAE Related to Clinical Laboratory Tests	Up to 52 weeks	Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).
Number of Participants With Markedly Abnormal Vital Signs Values	Up to 52 weeks	Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Here "mmHg" is Millimeter of mercury. Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).
Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)	Up to 52 weeks	Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).
Number of Participants With TEAE Related to Body Weight (Weight Loss)	Up to 52 weeks	Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).