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Parkinson's DiseasePhase 3NCT02337751

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

A Phase 3 study testing TVP-1012 1mg in people with Parkinson's Disease, run by Takeda at 56 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 79 years
Conditions the study is for
Parkinson's Disease
What is being tested?
TVP-1012 1mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
56 sitesJapan
Study dates
10 Jul 2015to 14 Mar 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

Japan56 sites

  • Study site

    Akashi, Hyōgo

  • Study site

    Akita

  • Study site

    Aomori

  • Study site

    Asahikawa, Hokkaido

  • Study site

    Bunkyo-ku, Tokyo

  • Study site

    Fuchū, Tokyo

  • Study site

    Fuji, Shizuoka

  • Study site

    Fujisawa, Kanagawa

  • Study site

    Fukuoka

  • Study site

    Fukushima

  • Study site

    Gōshi, Kumamoto

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Higashiosaka, Osaka

  • Study site

    Hiroshima

  • Study site

    Ichinoseki, Iwate

  • Study site

    Irima, Saitama

  • Study site

    Iwamizawa, Hokkaido

  • Study site

    Izunokuni, Shizuoka

  • Study site

    Jōetsu, Niigata

  • Study site

    Kitakyushu, Fukuoka

  • Study site

    Kobe, Hyōgo

  • Study site

    Kochi

  • Study site

    Kodaira, Tokyo

  • Study site

    Kyoto

  • Study site

    Matsumoto, Nagano

  • Study site

    Matsuyama, Ehime

  • Study site

    Meguro-ku, Tokyo

  • Study site

    Morioka, Iwate

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nerima-ku, Tokyo

  • Study site

    Niigata

  • Study site

    Nishisonogi, Nagasaki

  • Study site

    Okayama

  • Study site

    Ōnojō, Fukuoka

  • Study site

    Osaka

  • Study site

    Ōta-ku, Tokyo

  • Study site

    Sagamihara, Kanagawa

  • Study site

    Sendai, Miyagi

  • Study site

    Setagaya-ku, Tokyo

  • Study site

    Shibuya-ku, Tokyo

  • Study site

    Shimono, Tochigi

  • Study site

    Sonogishukugō, Nagasaki

  • Study site

    Suita, Osaka

  • Study site

    Takamatsu, Kagawa-ken

  • Study site

    Takatsuki, Osaka

  • Study site

    Tenri, Nara

  • Study site

    Tokushima

  • Study site

    Tōon, Ehime

  • Study site

    Toyama

  • Study site

    Toyonaka, Osaka

  • Study site

    Tsuchiura, Ibaraki

  • Study site

    Tsukuba, Ibaraki

  • Study site

    Wakayama

  • Study site

    Yamagata

  • Study site

    Yokohama, Kanagawa

  • Study site

    Yoshinogawa, Tokushima

Other trials in Japan

About this study

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

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.

Read the 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.

Being tested
TVP-1012 1mg
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TVP-1012 1mgDrug

    TVP-1012 1mg Tablets

Study groups in NCT02337751
Study groupRoleWhat they receive
TVP-1012 1mg GroupExperimentalTVP-1012 (1 mg/day) once daily, either before or after breakfast.
Receives: Drug: TVP-1012 1mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 52 weeks

Secondary outcomes (5)

  1. 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).

    Measured: Up to 52 weeks

  2. 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).

    Measured: Up to 52 weeks

  3. 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).

    Measured: Up to 52 weeks

  4. 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).

    Measured: Up to 52 weeks

  5. 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).

    Measured: Baseline to End of treatment (Week 52)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2015 (estimated)
  2. Study start10 Jul 2015
  3. Primary completion14 Mar 2017
  4. Study completion14 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02337751
Sponsor's protocol ID
TVP-1012/OCT-001
Other IDs
U1111-1165-1437, JapicCTI-152761
Status last verified
Feb 2022
First submitted
9 Jan 2015
Last updated
2 Mar 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 30689042

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TVP-1012 1mg in people with Parkinson's Disease, run by Takeda at 56 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02337751, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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