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

torstai 17. helmikuuta 2022 päivittänyt: Takeda

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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

244

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Japani
      • Akita, Japani
      • Aomori, Japani
      • Fukuoka, Japani
      • Fukushima, Japani
      • Hiroshima, Japani
      • Kochi, Japani
      • Kyoto, Japani
      • Niigata, Japani
      • Okayama, Japani
      • Osaka, Japani
      • Tokushima, Japani
      • Toyama, Japani
      • Wakayama, Japani
      • Yamagata, Japani
    • Aichi
      • Nagoya, Aichi, Japani
    • Ehime
      • Matsuyama, Ehime, Japani
      • Touon, Ehime, Japani
    • Fukuoka
      • Kitakyushu, Fukuoka, Japani
      • Onoshiro, Fukuoka, Japani
    • Hokkaido
      • Asahikawa, Hokkaido, Japani
      • Iwamizawa, Hokkaido, Japani
    • Hyogo
      • Akashi, Hyogo, Japani
      • Kobe, Hyogo, Japani
    • Ibaragi
      • Tsuchiura, Ibaragi, Japani
      • Tsukuba, Ibaragi, Japani
    • Iwate
      • Morioka, Iwate, Japani
    • Kagawa
      • Takamatsu, Kagawa, Japani
    • Kanagawa
      • Fujisawa, Kanagawa, Japani
      • Sagamihara, Kanagawa, Japani
      • Yokohama, Kanagawa, Japani
    • Kumamoto
      • Goushi, Kumamoto, Japani
    • Miyagi
      • Sendai, Miyagi, Japani
    • Nagano
      • Matsumoto, Nagano, Japani
    • Nagasaki
      • Higashisonogi-gun, Nagasaki, Japani
      • Nishisonogi-gun, Nagasaki, Japani
    • Nara
      • Tenri, Nara, Japani
    • Niigata
      • Jouetsu, Niigata, Japani
    • Osaka
      • Higashiosaka, Osaka, Japani
      • Suita, Osaka, Japani
      • Takatsuki, Osaka, Japani
      • Toyonaka, Osaka, Japani
    • Saitama
      • Irima-gun, Saitama, Japani
    • Shizuoka
      • Fuji, Shizuoka, Japani
      • Hamamatsu, Shizuoka, Japani
      • Izunokuni, Shizuoka, Japani
    • Tochigi
      • Shimono, Tochigi, Japani
    • Tokushima
      • Yoshinogawa, Tokushima, Japani
    • Tokyo
      • Bunkyo-ku, Tokyo, Japani
      • Fuchu, Tokyo, Japani
      • Kodaira, Tokyo, Japani
      • Meguro-ku, Tokyo, Japani
      • Nerima-ku, Tokyo, Japani
      • Ota-ku, Tokyo, Japani
      • Setagaya-ku, Tokyo, Japani
      • Shibuya-ku, Tokyo, Japani

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

30 vuotta - 80 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

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.
  • 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.

Exclusion Criteria:

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.
  • 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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: TVP-1012 1 mg
For 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.
Lääke: TVP-1012
TVP-1012 1mg Tablets
Placebo Comparator: Placebo
For 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.
Lääke: Plasebo
Placebo tabletit

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score
Aikaikkuna: From Baseline to Week 26 (LOCF)
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.
From Baseline to Week 26 (LOCF)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Niiden osallistujien määrä, jotka kokevat vähintään yhden hoidon aiheuttaman haittatapahtuman (TEAE) ja vakavan haittatapahtuman (SAE)
Aikaikkuna: Viikolle 26 asti
Viikolle 26 asti
Osallistujien määrä, joilla on selvästi epänormaalit elintoimintojen arvot
Aikaikkuna: Viikolle 26 asti
Viikolle 26 asti
Kliinisiin laboratoriotutkimuksiin liittyvien TEAE:n saaneiden osallistujien määrä
Aikaikkuna: Viikolle 26 asti
Viikolle 26 asti
Change From Baseline in MDS-UPDRS Part I Total Score
Aikaikkuna: Baseline and Week 26 (LOCF)
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.
Baseline and Week 26 (LOCF)
Change From Baseline in MDS-UPDRS Part II Total Score
Aikaikkuna: Baseline and Week 26 (LOCF)
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.
Baseline and Week 26 (LOCF)
Change From Baseline in MDS-UPDRS Part III Total Score
Aikaikkuna: Baseline and Week 26 (LOCF)
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.
Baseline and Week 26 (LOCF)
Number of Participants With TEAE Related to Body Weight
Aikaikkuna: Up to Week 26
Up to Week 26
Number of Participants With TEAE Related to Electrocardiograms (ECG)
Aikaikkuna: Up to Week 26
Up to Week 26

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Takeda

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Lauantai 7. helmikuuta 2015

Ensisijainen valmistuminen (Todellinen)

Torstai 15. syyskuuta 2016

Opintojen valmistuminen (Todellinen)

Torstai 15. syyskuuta 2016

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 9. tammikuuta 2015

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 9. tammikuuta 2015

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 14. tammikuuta 2015

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 2. maaliskuuta 2022

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 17. helmikuuta 2022

Viimeksi vahvistettu

Tiistai 1. helmikuuta 2022

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • TVP-1012/CCT-001
  • U1111-1165-1302 (Rekisterin tunniste: WHO)
  • JapicCTI-152760 (Rekisterin tunniste: JapicCTI)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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.

IPD-jaon käyttöoikeuskriteerit

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.

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • ICF
  • CSR

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

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