A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants
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
3 other identifiers
interventional
198
1 country
56
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2015
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2015
CompletedFirst Posted
Study publicly available on registry
January 14, 2015
CompletedStudy Start
First participant enrolled
July 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2017
CompletedResults Posted
Study results publicly available
February 28, 2019
CompletedMarch 2, 2022
February 1, 2022
1.7 years
January 9, 2015
February 25, 2018
February 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Number of Participants With TEAE Related to Clinical Laboratory Tests
Up to 52 weeks
Number of Participants With Markedly Abnormal Vital Signs Values
Up to 52 weeks
Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)
Up to 52 weeks
Number of Participants With TEAE Related to Body Weight (Weight Loss)
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
Baseline to End of treatment (Week 52)
Study Arms (1)
TVP-1012 1mg Group
EXPERIMENTALTVP-1012 (1 mg/day) once daily, either before or after breakfast.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (56)
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Matsuyama, Ehime, Japan
Unknown Facility
Tōon, Ehime, Japan
Unknown Facility
Kitakyushu, Fukuoka, Japan
Unknown Facility
Ōnojō, Fukuoka, Japan
Unknown Facility
Asahikawa, Hokkaido, Japan
Unknown Facility
Iwamizawa, Hokkaido, Japan
Unknown Facility
Akashi, Hyōgo, Japan
Unknown Facility
Kobe, Hyōgo, Japan
Unknown Facility
Tsuchiura, Ibaraki, Japan
Unknown Facility
Tsukuba, Ibaraki, Japan
Unknown Facility
Ichinoseki, Iwate, Japan
Unknown Facility
Morioka, Iwate, Japan
Unknown Facility
Takamatsu, Kagawa-ken, Japan
Unknown Facility
Fujisawa, Kanagawa, Japan
Unknown Facility
Sagamihara, Kanagawa, Japan
Unknown Facility
Yokohama, Kanagawa, Japan
Unknown Facility
Gōshi, Kumamoto, Japan
Unknown Facility
Sendai, Miyagi, Japan
Unknown Facility
Matsumoto, Nagano, Japan
Unknown Facility
Nishisonogi, Nagasaki, Japan
Unknown Facility
Sonogishukugō, Nagasaki, Japan
Unknown Facility
Tenri, Nara, Japan
Unknown Facility
Jōetsu, Niigata, Japan
Unknown Facility
Higashiosaka, Osaka, Japan
Unknown Facility
Suita, Osaka, Japan
Unknown Facility
Takatsuki, Osaka, Japan
Unknown Facility
Toyonaka, Osaka, Japan
Unknown Facility
Irima, Saitama, Japan
Unknown Facility
Fuji, Shizuoka, Japan
Unknown Facility
Hamamatsu, Shizuoka, Japan
Unknown Facility
Izunokuni, Shizuoka, Japan
Unknown Facility
Shimono, Tochigi, Japan
Unknown Facility
Yoshinogawa, Tokushima, Japan
Unknown Facility
Bunkyo-ku, Tokyo, Japan
Unknown Facility
Fuchū, Tokyo, Japan
Unknown Facility
Kodaira, Tokyo, Japan
Unknown Facility
Meguro-ku, Tokyo, Japan
Unknown Facility
Nerima-ku, Tokyo, Japan
Unknown Facility
Ōta-ku, Tokyo, Japan
Unknown Facility
Setagaya-ku, Tokyo, Japan
Unknown Facility
Shibuya-ku, Tokyo, Japan
Unknown Facility
Akita, Japan
Unknown Facility
Aomori, Japan
Unknown Facility
Fukuoka, Japan
Unknown Facility
Fukushima, Japan
Unknown Facility
Hiroshima, Japan
Unknown Facility
Kochi, Japan
Unknown Facility
Kyoto, Japan
Unknown Facility
Niigata, Japan
Unknown Facility
Okayama, Japan
Unknown Facility
Osaka, Japan
Unknown Facility
Tokushima, Japan
Unknown Facility
Toyama, Japan
Unknown Facility
Wakayama, Japan
Unknown Facility
Yamagata, Japan
Related Publications (1)
Hattori N, Takeda A, Takeda S, Nishimura A, Kitagawa T, Mochizuki H, Nagai M, Takahashi R. Long-term, open-label, phase 3 study of rasagiline in Japanese patients with early Parkinson's disease. J Neural Transm (Vienna). 2019 Mar;126(3):299-308. doi: 10.1007/s00702-018-1964-3. Epub 2019 Jan 28.
PMID: 30689042DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2015
First Posted
January 14, 2015
Study Start
July 10, 2015
Primary Completion
March 14, 2017
Study Completion
March 14, 2017
Last Updated
March 2, 2022
Results First Posted
February 28, 2019
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.