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Parkinson's DiseasePhase 3NCT02337725

A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients

A Phase 3 study testing TVP-1012 in people with Parkinson's Disease, run by Takeda at 55 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 (1 mg/day) administered to Japanese patients with early Parkinson's disease. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
TVP-1012
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
244 participants
Where
55 sitesJapan
Study dates
7 Feb 2015to 15 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Run-in period
  • 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 with at least two of the following signs: resting tremor, akinesia/bradykinesia, and muscle rigidity.
  • The participant has a Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III total score of >=14 at the start of the run-in period.
  • The participant has Modified Hoehn \& Yahr stage 1 to 3 at the start of the run-in period.
Show all 11Show fewer
  • The participant has the Parkinson's disease diagnosed within 5 years prior to the start of the run-in period.
  • The participant is an outpatient of either sex aged >= 30 and < 80 years.
  • 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.
  • Treatment period
  • The participant has a MDS-UPDRS Part II + Part III total score of >= 14 at baseline.

Who cannot join

  • Run-in period
  • 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 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.
Show all 42Show 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 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 amantadine or anticholinergic medication for >= 180 days.
  • The participant has received selegiline, a levodopa-containing product or dopamine agonist for >= 90 days.
  • 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 a levodopa-containing product, dopamine agonist, amantadine or anticholinergic drug within 30 days prior to the start of the run-in period.
  • The participant has received 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 has previously received a catechol-O-methyltransferase (COMT) inhibitor, droxidopa, zonisamide or istradefylline.
  • 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 this study, or within 1 month after the last dose of the investigational drug; 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,
  • cardiac arrest 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 start of the run-in period,
  • sever 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 systolic pressure decrease of 30 mmHg or more following postural change from supine/sitting position to standing position),
  • a history of syncope due to hypotension within 2 years prior to the start 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 who, in the opinion of the investigator or sub-investigator, is unsuitable for any other reason.
  • Treatment period
  • The participant whose diagonosis of Parkinson's disease is ruled out by dopamine transporter scintigraphy performed during the run-in period if conducted.
  • 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.

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

Japan55 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

    Higashisonogi-gun, Nagasaki

  • Study site

    Hiroshima

  • Study site

    Irima-gun, Saitama

  • Study site

    Iwamizawa, Hokkaido

  • Study site

    Izunokuni, Shizuoka

  • Study site

    Jouetsu, 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-gun, Nagasaki

  • Study site

    Okayama

  • Study site

    Onoshiro, 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

    Suita, Osaka

  • Study site

    Takamatsu, Kagawa-ken

  • Study site

    Takatsuki, Osaka

  • Study site

    Tenri, Nara

  • Study site

    Tokushima

  • Study site

    Touon, Ehime

  • Study site

    Toyama

  • Study site

    Toyonaka, Osaka

  • Study site

    Tsuchiura, Ibaragi

  • Study site

    Tsukuba, Ibaragi

  • 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, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety 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 efficacy and safety of TVP-1012 (1 mg/day) administered to Japanese patients with early Parkinson's disease.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to evaluate the efficacy and safety of TVP-1012 in Japanese participants with early Parkinson's disease.

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

Being tested
TVP-1012, 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-1012Drug

    TVP-1012 1mg Tablets

  • PlaceboDrug

    Placebo tablets

Study groups in NCT02337725
Study groupRoleWhat they receive
TVP-1012 1 mgExperimentalFor 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.
Receives: Drug: TVP-1012
PlaceboPlacebo comparatorFor 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
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 Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score

    Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (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+III Total Score was 0-188, with higher scores reflecting greater severity.

    Measured: From Baseline to Week 26 (LOCF)

Secondary outcomes (8)

  1. Change From Baseline in MDS-UPDRS Part I Total Score

    For MDS-UPDRS Part I (non-motor experiences of daily living) scores, the scale range for Part I Total Score was 0-52, with higher scores reflecting greater severity.

    Measured: Baseline and Week 26 (LOCF)

  2. Change From Baseline in MDS-UPDRS Part II Total Score

    For MDS-UPDRS Part II (motor experiences of daily living) 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

    For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity.

    Measured: Baseline and Week 26 (LOCF)

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

    Measured: Up to Week 26

  5. Number of Participants With Markedly Abnormal Vital Signs Values

    Measured: Up to Week 26

  6. Number of Participants With TEAE Related to Body Weight

    Measured: Up to Week 26

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

    Measured: Up to Week 26

  8. 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 start7 Feb 2015
  3. Primary completion15 Sep 2016
  4. Study completion15 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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02337725
Sponsor's protocol ID
TVP-1012/CCT-001
Other IDs
U1111-1165-1302, JapicCTI-152760
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. Rasagiline monotherapy in early Parkinson's disease: A phase 3, randomized study in Japan. Parkinsonism Relat Disord. 2019 Mar;60:146-152. doi: 10.1016/j.parkreldis.2018.08.024. Epub 2018 Sep 1.

    PubMed 30205936

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TVP-1012 in people with Parkinson's Disease, run by Takeda at 55 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 11 inclusion and 42 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 55 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 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 31 Dec 2018). 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 Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score (time frame: From Baseline to Week 26 (LOCF)). 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 NCT02337725, 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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