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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TVP-1012 1mg
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TVP-1012 1mg Group

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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).
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).

Full Information

First Posted
January 9, 2015
Last Updated
February 17, 2022
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT02337751
Brief Title
A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 10, 2015 (Actual)
Primary Completion Date
March 14, 2017 (Actual)
Study Completion Date
March 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TVP-1012 1mg Group
Arm Type
Experimental
Arm Description
TVP-1012 (1 mg/day) once daily, either before or after breakfast.
Intervention Type
Drug
Intervention Name(s)
TVP-1012 1mg
Intervention Description
TVP-1012 1mg Tablets
Primary Outcome Measure Information:
Title
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Description
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 Outcome Measure Information:
Title
Number of Participants With TEAE Related to Clinical Laboratory Tests
Description
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
Title
Number of Participants With Markedly Abnormal Vital Signs Values
Description
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
Title
Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)
Description
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
Title
Number of Participants With TEAE Related to Body Weight (Weight Loss)
Description
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
Title
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score
Description
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).
Time Frame
Baseline to End of treatment (Week 52)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Nagoya
State/Province
Aichi
Country
Japan
City
Matsuyama
State/Province
Ehime
Country
Japan
City
Toon
State/Province
Ehime
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
City
Onojo
State/Province
Fukuoka
Country
Japan
City
Asahikawa
State/Province
Hokkaido
Country
Japan
City
Iwamizawa
State/Province
Hokkaido
Country
Japan
City
Akashi
State/Province
Hyogo
Country
Japan
City
Kobe
State/Province
Hyogo
Country
Japan
City
Tsuchiura
State/Province
Ibaraki
Country
Japan
City
Tsukuba
State/Province
Ibaraki
Country
Japan
City
Ichinoseki
State/Province
Iwate
Country
Japan
City
Morioka
State/Province
Iwate
Country
Japan
City
Takamatsu
State/Province
Kagawa
Country
Japan
City
Fujisawa
State/Province
Kanagawa
Country
Japan
City
Sagamihara
State/Province
Kanagawa
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Goshi
State/Province
Kumamoto
Country
Japan
City
Sendai
State/Province
Miyagi
Country
Japan
City
Matsumoto
State/Province
Nagano
Country
Japan
City
Higashisonogi
State/Province
Nagasaki
Country
Japan
City
Nishisonogi
State/Province
Nagasaki
Country
Japan
City
Tenri
State/Province
Nara
Country
Japan
City
Joetsu
State/Province
Niigata
Country
Japan
City
Higashiosaka
State/Province
Osaka
Country
Japan
City
Suita
State/Province
Osaka
Country
Japan
City
Takatsuki
State/Province
Osaka
Country
Japan
City
Toyonaka
State/Province
Osaka
Country
Japan
City
Irima
State/Province
Saitama
Country
Japan
City
Fuji
State/Province
Shizuoka
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
City
Izunokuni
State/Province
Shizuoka
Country
Japan
City
Shimono
State/Province
Tochigi
Country
Japan
City
Yoshinogawa
State/Province
Tokushima
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
City
Fuchu
State/Province
Tokyo
Country
Japan
City
Kodaira
State/Province
Tokyo
Country
Japan
City
Meguro-ku
State/Province
Tokyo
Country
Japan
City
Nerima-ku
State/Province
Tokyo
Country
Japan
City
Ota-ku
State/Province
Tokyo
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
City
Shibuya-ku
State/Province
Tokyo
Country
Japan
City
Akita
Country
Japan
City
Aomori
Country
Japan
City
Fukuoka
Country
Japan
City
Fukushima
Country
Japan
City
Hiroshima
Country
Japan
City
Kochi
Country
Japan
City
Kyoto
Country
Japan
City
Niigata
Country
Japan
City
Okayama
Country
Japan
City
Osaka
Country
Japan
City
Tokushima
Country
Japan
City
Toyama
Country
Japan
City
Wakayama
Country
Japan
City
Yamagata
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/takeda/
Citations:
PubMed Identifier
30689042
Citation
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.
Results Reference
derived

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

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