A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Participants
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients With Wearing Off
3 other identifiers
interventional
404
1 country
57
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (0.5 mg or 1 mg/day) as an add-on to levodopa in Japanese participants with Parkinson's disease with wearing-off phenomenon.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2015
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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
January 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2016
CompletedResults Posted
Study results publicly available
February 28, 2019
CompletedMarch 2, 2022
February 1, 2022
1.6 years
January 9, 2015
September 15, 2017
February 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Mean Daily OFF-time During Treatment Period
Reported change from baseline during treatment period which was calculated as follows: Mean for a total of 21 days, consisting of three separate 7-day periods preceding the visits at Week 6, 14 and 26 of the treatment period - Mean for the 7 days preceding the visit at the end of the run-in period. Off-time refers to times when levodopa is not working well, causing worsening symptoms.
From Baseline to Week 26
Secondary Outcomes (10)
Change From Baseline to Week 26 (LOCF) in Mean Daily OFF-time
Baseline and Week 26 (LOCF)
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Total Score
Baseline and Week 26 (LOCF)
Change From Baseline in MDS-UPDRS Part III Total Score
Baseline and Week 26 (LOCF)
Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Score
Baseline and Week 26 (LOCF)
Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Each Domain Score
Baseline and Week 26 (LOCF)
- +5 more secondary outcomes
Study Arms (3)
TVP-1012 1mg
EXPERIMENTALTVP-1012 1 mg once daily orally, before or after breakfast, concomitantly with levodopa tablet for 26 weeks as treatment period after 2 weeks of run-in period.
TVP-1012 0.5mg
EXPERIMENTALTVP-1012 0.5 mg once daily orally, before or after breakfast, concomitantly with levodopa tablet for 26 weeks as treatment period after 2 weeks of run-in period.
Placebo
PLACEBO COMPARATOROne placebo tablet once daily orally, before or after breakfast, concomitantly with levodopa tablet for 26 weeks as treatment period after 2 weeks of run-in period.
Interventions
Eligibility Criteria
You may qualify if:
- In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- The participant has a diagnosis of Parkinson's disease according to the diagnostic criteria of the UK Parkinson's Disease Society Brain Bank.
- The participant has Modified Hoehn \& Yahr stage 2 to 4 (in the "Off" state) at the start of the run-in period.
- The participant has wearing off phenomenon and has been continuously receiving a levodopa combination drug for \>= 6 months prior to the start of the run-in period.
- The participant has been receiving a levodopa combination drug with a stable dose regimen (dosing frequency, at least 3 times a day) since the start of the run-in period.
- For participants receiving eantacapone concomitantly,the participant has been receiving entacapone with a stable dose regimen from the start of the run-in period.
- For participants receiving a dopamine agonist, anticholinergic drug, amantadine, droxidopa, istradefylline, or zonisamide concomitantly, the participant has been receiving those drugs with a stable dose regimen since 14 days prior to the start of the run-in period.
- The participant is an outpatient of either sex aged \>= 30 and \< 80 years at the time of consent.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent to 1 month after the last dose of the investigational drug.
- The participant has completed patient diary for at least 4 of the 7 days preceding the study visit at the end of the run-in period.
- The participant has mean daily off-time of \>= 2.5 hours at the end of the run-in period
You may not qualify if:
- The participant has received any investigational medication within 90 days prior to the start of the run-in period.
- The participant has received TVP-1012 in the past.
- The participant is a study site employee, an immediate family member, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
- Participant has donated 400 mL or more of his or her blood volume within 90 days prior to the start of the run-in period.
- The participant has unstable systemic disease.
- The participant has severe dyskinesia.
- The participant has Mini-Mental State Examination (MMSE) score of \<= 24 at the start of the run-in period.
- The participant has known or a history of schizophrenia, major or severe depression, or any other clinically significant psychiatric disease
- The participant has major depression or severe depression, or any other clinically significant psychiatric disease.
- The participant has a history of hypersensitivity or allergies to TVP-1012 (including any associated excipients) or selegiline.
- The participant has a history of clinically significant hypertension or other reactions associated with ingestion of tyramine-rich food (e.g., cheese, lever, herring, yeast, horsebean, banana, beer or wine).
- The participant has a history or concurrent of drug abuse or alcohol dependence.
- The participant has received neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, deep brain stimulation).
- The participant has received transcranial magnetic stimulation within 6 months prior to the start of the run-in period.
- The participant has received selegiline, pethidine, tramadol, reserpine or methyldopa within 90 days prior to the start of the run-in period.
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (57)
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Matsuyama, Ehime, Japan
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Touon, Ehime, Japan
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Kitakyushu, Fukuoka, Japan
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Onoshiro, Fukuoka, Japan
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Aizu-Wakamatsu, Fukushima, Japan
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Fujioka, Gunma, Japan
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Asahikawa, Hokkaido, Japan
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Iwamizawa, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Akashi, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Tsukuba, Ibaragi, Japan
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Morioka, Iwate, Japan
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Takamatsu, Kagawa-ken, Japan
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Fujisawa, Kanagawa, Japan
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Kawasaki, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Nankoku, Kochi, Japan
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Gōshi, Kumamoto, Japan
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Sendai, Miyagi, Japan
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Matsumoto, Nagano, Japan
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Higashisonogi-gun, Nagasaki, Japan
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Jōetsu, Niigata, Japan
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Yufu, Oita Prefecture, Japan
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Higashiosaka, Osaka, Japan
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Hirakata, Osaka, Japan
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Suita, Osaka, Japan
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Takatsuki, Osaka, Japan
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Toyonaka, Osaka, Japan
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Irima-gun, Saitama, Japan
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Fuji, Shizuoka, Japan
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Hamamatsu, Shizuoka, Japan
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Izunokuni, Shizuoka, Japan
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Shimono, Tochigi, Japan
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Yoshinogawa, Tokushima, Japan
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Bunkyo-ku, Tokyo, Japan
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Fuchū, Tokyo, Japan
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Kodaira, Tokyo, Japan
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Nerima-ku, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Setagaya-ku, Tokyo, Japan
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Shibuya-ku, Tokyo, Japan
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Akita, Japan
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Aomori, Japan
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Chiba, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Hiroshima, Japan
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Kyoto, Japan
Unknown Facility
Miyazaki, 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
Related Publications (1)
Hattori N, Takeda A, Hanya Y, Kitagawa T, Arai M, Furusawa Y, Mochizuki H, Nagai M, Takahashi R. Effects of rasagiline on Parkinson's Disease Questionnaire (PDQ-39) emotional well-being domain in patients with Parkinson's disease: A post-hoc analysis of clinical trials in Japan. PLoS One. 2022 Jan 25;17(1):e0262796. doi: 10.1371/journal.pone.0262796. eCollection 2022.
PMID: 35077474DERIVED
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 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2015
First Posted
January 14, 2015
Study Start
January 27, 2015
Primary Completion
September 17, 2016
Study Completion
September 17, 2016
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.