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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: TVP-1012 1mg

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 Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Akita, Japan
  • Aomori, Japan
  • Fukuoka, Japan
  • Fukushima, Japan
  • Hiroshima, Japan
  • Kochi, Japan
  • Kyoto, Japan
  • Niigata, Japan
  • Okayama, Japan
  • Osaka, Japan
  • Tokushima, Japan
  • Toyama, Japan
  • Wakayama, Japan
  • Yamagata, Japan
  • Aichi
    • Nagoya, Aichi, Japan
  • Ehime
    • Matsuyama, Ehime, Japan
    • Toon, Ehime, Japan
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan
    • Onojo, Fukuoka, Japan
  • Hokkaido
    • Asahikawa, Hokkaido, Japan
    • Iwamizawa, Hokkaido, Japan
  • Hyogo
    • Akashi, Hyogo, Japan
    • Kobe, Hyogo, Japan
  • Ibaraki
    • Tsuchiura, Ibaraki, Japan
    • Tsukuba, Ibaraki, Japan
  • Iwate
    • Ichinoseki, Iwate, Japan
    • Morioka, Iwate, Japan
  • Kagawa
    • Takamatsu, Kagawa, Japan
  • Kanagawa
    • Fujisawa, Kanagawa, Japan
    • Sagamihara, Kanagawa, Japan
    • Yokohama, Kanagawa, Japan
  • Kumamoto
    • Goshi, Kumamoto, Japan
  • Miyagi
    • Sendai, Miyagi, Japan
  • Nagano
    • Matsumoto, Nagano, Japan
  • Nagasaki
    • Higashisonogi, Nagasaki, Japan
    • Nishisonogi, Nagasaki, Japan
  • Nara
    • Tenri, Nara, Japan
  • Niigata
    • Joetsu, Niigata, Japan
  • Osaka
    • Higashiosaka, Osaka, Japan
    • Suita, Osaka, Japan
    • Takatsuki, Osaka, Japan
    • Toyonaka, Osaka, Japan
  • Saitama
    • Irima, Saitama, Japan
  • Shizuoka
    • Fuji, Shizuoka, Japan
    • Hamamatsu, Shizuoka, Japan
    • Izunokuni, Shizuoka, Japan
  • Tochigi
    • Shimono, Tochigi, Japan
  • Tokushima
    • Yoshinogawa, Tokushima, Japan
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan
    • Fuchu, Tokyo, Japan
    • Kodaira, Tokyo, Japan
    • Meguro-ku, Tokyo, Japan
    • Nerima-ku, Tokyo, Japan
    • Ota-ku, Tokyo, Japan
    • Setagaya-ku, Tokyo, Japan
    • Shibuya-ku, Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Takeda

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2015
• Primary Completion (Actual): March 14, 2017
• Study Completion (Actual): March 14, 2017

Study Registration Dates

• First Submitted: January 9, 2015
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimate): January 14, 2015

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: TVP-1012/OCT-001; U1111-1165-1437 (Registry Identifier: WHO); JapicCTI-152761 (Registry Identifier: JapicCTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No