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Parkinson's DiseasePhase 2/3NCT02337738

A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Participants

A Phase 2/3 study testing TVP-1012 1mg and TVP-1012 0.5mg in people with Parkinson's Disease, run by Takeda at 57 sites in Japan.

Completed

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

Official record
Search all trials

Trial 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. 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 and TVP-1012 0.5mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
404 participants
Where
57 sitesJapan
Study dates
27 Jan 2015to 17 Sep 2016
Phase
Phase 2/3
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

  • 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.
Show all 12Show fewer
  • 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

Who cannot join

  • 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.
Show all 37Show fewer
  • 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.
  • The participant has received single agent of levodopa, any psychoneurotic agent or antiemetic medication of dopamine antagonist within 14 days prior to the start of the run-in period. However, the participant has been receiving quetiapine or domperidone with a stable dose regimen for >= 14 days prior to the start of the run-in period may be included in the study.
  • The participant is required to take any of the prohibited concomitant medications or treatments.
  • If female, the participant is pregnant or lactating or intending to become pregnant during, or within 1 month after the last administration of study medication in this study; or intending to donate ova during such time period.
  • The participant has clinically significant neurologic, cardiovascular, pulmonary, hepatic (including mild cirrhosis), renal, metabolic, gastrointestinal, urological, endocrine, or hematological disease.
  • The participant has clinically significant or unstable brain or cardiovascular disease, such as:
  • clinically significant arrhythmia or cardiac valvulopathy,
  • heart failure of NYHA Class II or higher,
  • concurrent or a history of ischemic cardiac disease within 6 months prior to the start of the run-in period,
  • concurrent or a history of clinically significant cerebrovascular disease within 6 months prior to the stat of the run-in period,
  • severe hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher),
  • clinically significant orthostatic hypotension (including those with diastolic pressure decrease of 30 mmHg or more following postural change from supine/sitting position to standing position), or
  • a history of syncope due to hypotension within 2 years prior to the stat of the run-in period.
  • The participant is required surgery or hospitalization for surgery during the study period.
  • Participant has a history of cancer within 5 years prior to the start of the run-in period, except cervix carcinoma in situ which has completely cured.
  • The participant has acquired immunodeficiency syndrome (AIDS) [including human immunodeficiency virus (HIV) carrier], or hepatitis [including viral hepatitis carrier such as hepatitis B surface (HBs) antigen or hepatitis C antibody (HCV) positive]. However, the participant who has a negative result for HCV antigen or HCV-RNA can be included in the study.
  • The participant has laboratory data meeting any of the following at the start of the run-in period:
  • Creatinine >= 2 x upper limit of normal (ULN)
  • Total bilirubin >= 2 x ULN
  • ALT or AST >= 1.5 x ULN
  • ALP >= 3 x ULN
  • The participant has received any of the prohibited concomitant medications or treatments during the run-in period.
  • The participant who, in the opinion of the investigator or sub-investigator, is unsuitable for any other reason.

Trial locations and contacts

57 sites in 1 country.

57 sites in 1 country

Japan57 sites

  • Study site

    Aizu-Wakamatsu, Fukushima

  • Study site

    Akashi, Hyōgo

  • Study site

    Akita

  • Study site

    Aomori

  • Study site

    Asahikawa, Hokkaido

  • Study site

    Bunkyo-ku, Tokyo

  • Study site

    Chiba

  • Study site

    Fuchū, Tokyo

  • Study site

    Fuji, Shizuoka

  • Study site

    Fujioka, Gunma

  • Study site

    Fujisawa, Kanagawa

  • Study site

    Fukuoka

  • Study site

    Fukushima

  • Study site

    Gōshi, Kumamoto

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Higashiosaka, Osaka

  • Study site

    Higashisonogi-gun, Nagasaki

  • Study site

    Hirakata, Osaka

  • Study site

    Hiroshima

  • Study site

    Irima-gun, Saitama

  • Study site

    Iwamizawa, Hokkaido

  • Study site

    Izunokuni, Shizuoka

  • Study site

    Jōetsu, Niigata

  • Study site

    Kawasaki, Kanagawa

  • Study site

    Kitakyushu, Fukuoka

  • Study site

    Kobe, Hyōgo

  • Study site

    Kodaira, Tokyo

  • Study site

    Kyoto

  • Study site

    Matsumoto, Nagano

  • Study site

    Matsuyama, Ehime

  • Study site

    Miyazaki

  • Study site

    Morioka, Iwate

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nankoku, Kochi

  • Study site

    Nerima-ku, Tokyo

  • Study site

    Niigata

  • Study site

    Okayama

  • Study site

    Onoshiro, Fukuoka

  • Study site

    Osaka

  • Study site

    Ōta-ku, Tokyo

  • Study site

    Sagamihara, Kanagawa

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sendai, Miyagi

  • Study site

    Setagaya-ku, Tokyo

  • Study site

    Shibuya-ku, Tokyo

  • Study site

    Shimono, Tochigi

  • Study site

    Suita, Osaka

  • Study site

    Takamatsu, Kagawa-ken

  • Study site

    Takatsuki, Osaka

  • Study site

    Tokushima

  • Study site

    Touon, Ehime

  • Study site

    Toyama

  • Study site

    Toyonaka, Osaka

  • Study site

    Tsukuba, Ibaragi

  • Study site

    Wakayama

  • Study site

    Yoshinogawa, Tokushima

  • Study site

    Yufu, Oita Prefecture

Other trials in Japan

About this study

Official title: 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

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.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, phase 2/3 study to evaluate the efficacy and safety of TVP-1012 as an add-on to levodopa in Japanese participants with Parkinson's disease with wearing-off phenomenon.

The study period consisted of a 28-week trial period. The participants who fulfilled the inclusion criteria and did not meeting any of the exclusion criteria were enrolled, and randomized in a 1:1:1 ratio to the 0.5 mg of TVP-1012, the 1 mg of TVP-1012, or the placebo group. In each treatment group, participants received 0.5 mg of TVP-1012, 1 mg of TVP-1012, or placebo once daily in a double-blinded manner.

Being tested
TVP-1012 1mg, TVP-1012 0.5mg, Placebo
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

  • TVP-1012 0.5mgDrug

    TVP-1012 0.5mg Tablets

  • PlaceboDrug

    Placebo Tablets

Study groups in NCT02337738
Study groupRoleWhat they receive
TVP-1012 1mgExperimentalTVP-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.
Receives: Drug: TVP-1012 1mg
TVP-1012 0.5mgExperimentalTVP-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.
Receives: Drug: TVP-1012 0.5mg
PlaceboPlacebo 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.
Receives: Drug: Placebo

What is being measured

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

  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.

    Measured: From Baseline to Week 26

Secondary outcomes (10)

  1. Change From Baseline to Week 26 (LOCF) in Mean Daily OFF-time

    Measured: Baseline and Week 26 (LOCF)

  2. Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Total Score

    MDS-UPDRS retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. Each items had 0-4 ratings, where 0 (normal) to 4 (severe) and score for each was summed to calculate the total scores. The scale range for Part II Total Score was 0-52, with higher scores reflecting greater severity.

    Measured: Baseline and Week 26 (LOCF)

  3. Change From Baseline in MDS-UPDRS Part III Total Score

    MDS-UPDRS retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. Each items had 0-4 ratings, where 0 (normal) to 4 (severe) and score for each was summed to calculate the total scores. The scale range for Part III Total Score was 0-136, with higher scores reflecting greater severity.

    Measured: Baseline and Week 26 (LOCF)

  4. Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Score

    PDQ-39 is a self-administered questionnaire. PDQ-39 comprises of 39 questions, relating to eight key areas (Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognitions, Communication, and Bodily Discomfort) of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms.

    Measured: Baseline and Week 26 (LOCF)

  5. Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Each Domain Score

    PDQ-39 is a self-administered questionnaire. PDQ-39 comprises of 39 questions, relating to eight key areas (Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognitions, Communication, and Bodily Discomfort) of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms.

    Measured: Baseline and Week 26 (LOCF)

  6. Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: Up to Week 26

  7. Number of Participants With Markedly Abnormal Vital Signs Values

    Measured: Up to Week 26

  8. Number of Participants With TEAE Related to Body Weight (Weight Decreased)

    Measured: Up to Week 26

  9. Number of Participants With TEAE Related to Electrocardiograms (ECG) (Sinus Bradycardia)

    Measured: Up to Week 26

  10. Number of Participants With TEAE Related to Clinical Laboratory Tests

    Measured: Up to Week 26

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 start27 Jan 2015
  3. Primary completion17 Sep 2016
  4. Study completion17 Sep 2016

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02337738
Sponsor's protocol ID
TVP-1012/CCT-002
Other IDs
U1111-1165-1364, JapicCTI-152759
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, 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.

    PubMed 35077474

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TVP-1012 1mg and TVP-1012 0.5mg in people with Parkinson's Disease, run by Takeda at 57 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 12 inclusion and 37 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 57 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change From Baseline in Mean Daily OFF-time During Treatment Period (time frame: From Baseline to Week 26). 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 NCT02337738, 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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