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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: TVP-1012 1mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TVP-1012 1mg Group<br>TVP-1012 (1 mg/day) once daily, either before or after breakfast. | Drug: TVP-1012 1mg<br>* TVP-1012 1mg Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 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). | Up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With TEAE Related to Clinical Laboratory Tests | 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). | Up to 52 weeks | 
| Number of Participants With Markedly Abnormal Vital Signs Values | 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). | Up to 52 weeks | 
| Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged) | 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). | Up to 52 weeks | 
| Number of Participants With TEAE Related to Body Weight (Weight Loss) | 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). | Up to 52 weeks | 
| Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score | 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). | Baseline to End of treatment (Week 52) |