AzTrials
AzTrials

Parkinson's DiseasePhase 3NCT02337764

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

A Phase 3 study testing TVP-1012 1mg in people with Parkinson's Disease, run by Takeda at 24 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 long-term safety of TVP-1012 (1 mg/day) with levodopa in Japanese participants with 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
222 participants
Where
24 sitesJapan
Study dates
3 Feb 2015to 29 Sep 2016
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

  • 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 received a levodopa combination drug for >= 1 month at the start of the run-in period and has either of the following.
  • Wearing off phenomenon
  • Decreased response to levodopa combination drugs
Show all 9Show fewer
  • The participant has been receiving a levodopa combination drug a stable dose regimen since 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.

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 Modified Hoehn \& Yahr stage 5 (or stage 5 at eather on-time or off-time for the participant with wearing off phenomenon) at the start of the run-in period.
  • The participant has severe dyskinesia.
Show all 37Show fewer
  • The participant has unstable systemic disease.
  • The participant has a Mini-Mental State Examinations (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 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 agonist 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 with 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

24 sites in 1 country.

24 sites in 1 country

Japan24 sites

  • Study site

    Chuo-ku, Tokyo

  • Study site

    Fukuoka, Fukouka

  • Study site

    Fukuoka

  • Study site

    Himeji, Hyōgo

  • Study site

    Ichinoseki, Iwate

  • Study site

    Kawasaki, Kanagawa

  • Study site

    Kobe, Hyōgo

  • Study site

    Kochi

  • Study site

    Kōriyama, Fukushima

  • Study site

    Kyoto

  • Study site

    Matsuyama, Ehime

  • Study site

    Meguro-ku, Tokyo

  • Study site

    Miyazaki

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Osaka

  • Study site

    Sagamihara, Kanagawa

  • Study site

    Sanda, Hyōgo

  • Study site

    Sapporo, Hokkaido

  • Study site

    Shimajiri-gun, Okinawa

  • Study site

    Shinjuku-ku, Tokyo

  • Study site

    Tenri, Nara

  • Study site

    Tsuchiura, Ibaragi

  • Study site

    Yamagata

  • Study site

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients

The purpose of this study is to evaluate long-term safety of TVP-1012 (1 mg/day) with levodopa in Japanese participants with Parkinson's disease.

Read the detailed description

This is a multicenter, open-label, long-term, phase 3 study to evaluate the safety and efficacy of long-term administration of TVP-1012 at 1 mg with levodopa in Japanese participants with Parkinson's disease.

The study period consisted of a 2-week run-in period and a subsequent 52-week treatment period. Participants fulfilling the inclusion criteria and did not meet any of the exclusion criteria at the start of the run-in period (Week -2) and also at the end of the run-in period (Week 0) were enrolled in the study, and received 1 mg of TVP-1012 once daily for 52 weeks, in an unblinded manner, from the day after Week 0.

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 NCT02337764
Study groupRoleWhat they receive
TVP-1012 1mgExperimentalTVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet for 52 weeks as treatment period after 2 weeks of run-in period.
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 Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: Up to Week 52

Secondary outcomes (7)

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

    Measured: Up to Week 52

  2. Number of Participants With Markedly Abnormal Vital Signs Values

    Measured: Up to Week 52

  3. Number of Participants With TEAE Related to Electrocardiograms (ECG)

    Measured: Up to Week 52

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

    Measured: Up to Week 52

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

    Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retained the four-scale structure with a reorganization of the various subscales; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (33 scores based on 18 items), and (Part IV) motor complications (6 items). Each items had 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II Total Score was 0-52, with higher scores reflecting greater severity.

    Measured: Baseline and Week 52 (LOCF)

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

    Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retained the four-scale structure with a reorganization of the various subscales; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (33 scores based on 18 items), and (Part IV) motor complications (6 items). Each items had 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity.

    Measured: Baseline and Week 52 (LOCF)

  7. Change From Baseline to Week 52 (LOCF) in Mean Daily OFF-time

    Off-time refers to times when levodopa is not working well, causing worsening symptoms.

    Measured: Baseline and Week 52 (LOCF)

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 start3 Feb 2015
  3. Primary completion29 Sep 2016
  4. Study completion29 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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02337764
Sponsor's protocol ID
TVP-1012/OCT-002
Other IDs
U1111-1165-1500, JapicCTI-152762
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.

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 24 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 9 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 24 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 19 Apr 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 Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to Week 52). 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 NCT02337764.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in