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

Takeda198 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

198

Conditions

Parkinson's Disease

Interventions

TVP-1012 1mgDRUG

TVP-1012 1mg Tablets

Eligibility

Sex: ALLMin age: 30 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (56)

Outcomes

Primary Outcomes

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).

Time frame: Up to 52 weeks

Secondary Outcomes

Number of Participants With TEAE Related to Clinical Laboratory Tests

Time frame: 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).

Time frame: Up to 52 weeks

Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)

Time frame: Up to 52 weeks

Number of Participants With TEAE Related to Body Weight (Weight Loss)

Data from ClinicalTrials.gov

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Nagoya, Aichi-ken, Japan

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Matsuyama, Ehime, Japan

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Tōon, Ehime, Japan

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Kitakyushu, Fukuoka, Japan

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Ōnojō, Fukuoka, Japan

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Asahikawa, Hokkaido, Japan

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Iwamizawa, Hokkaido, Japan

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Akashi, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Tsuchiura, Ibaraki, Japan

...and 46 more locations