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

Last updated: February 17, 2022
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

Parkinson's Disease

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT02337751
TVP-1012/OCT-001
JapicCTI-152761
U1111-1165-1437
  • Ages 30-79
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The participant has completed the preceding study.
  • The participant has shown no safety issues during the study treatment in the precedingstudy, in the opinion of the investigator or subinvestigator.

Exclusion

Exclusion Criteria:

  • The participant has undergone blood collection of >= 400 mL within 90 days prior tothe 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 studyperiod.

Study Design

Total Participants: 198
Study Start date:
July 10, 2015
Estimated Completion Date:
March 14, 2017

Study 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.

Connect with a study center

  • Nagoya, Aichi
    Japan

    Site Not Available

  • Matsuyama, Ehime
    Japan

    Site Not Available

  • Toon, Ehime
    Japan

    Site Not Available

  • empty

    Touon, Ehime
    Japan

    Site Not Available

  • Kitakyushu, Fukuoka
    Japan

    Site Not Available

  • Onojo, Fukuoka
    Japan

    Site Not Available

  • empty

    Onoshiro, Fukuoka
    Japan

    Site Not Available

  • Asahikawa, Hokkaido
    Japan

    Site Not Available

  • Iwamizawa, Hokkaido
    Japan

    Site Not Available

  • Akashi, Hyogo
    Japan

    Site Not Available

  • Kobe, Hyogo
    Japan

    Site Not Available

  • Tsuchiura, Ibaraki
    Japan

    Site Not Available

  • Tsukuba, Ibaraki
    Japan

    Site Not Available

  • Ichinoseki, Iwate
    Japan

    Site Not Available

  • empty

    Ichiseki, Iwate
    Japan

    Site Not Available

  • Morioka, Iwate
    Japan

    Site Not Available

  • Takamatsu, Kagawa
    Japan

    Site Not Available

  • Fujisawa, Kanagawa
    Japan

    Site Not Available

  • Sagamihara, Kanagawa
    Japan

    Site Not Available

  • Yokohama, Kanagawa
    Japan

    Site Not Available

  • Goshi, Kumamoto
    Japan

    Site Not Available

  • empty

    Goushi, Kumamoto
    Japan

    Site Not Available

  • Sendai, Miyagi
    Japan

    Site Not Available

  • Matsumoto, Nagano
    Japan

    Site Not Available

  • Higashisonogi, Nagasaki
    Japan

    Site Not Available

  • empty

    Higashisonogi-gun, Nagasaki
    Japan

    Site Not Available

  • Nishisonogi, Nagasaki
    Japan

    Site Not Available

  • empty

    Nishisonogi-gun, Nagasaki
    Japan

    Site Not Available

  • Tenri, Nara
    Japan

    Site Not Available

  • Joetsu, Niigata
    Japan

    Site Not Available

  • empty

    Jouetsu, Niigata
    Japan

    Site Not Available

  • Higashiosaka, Osaka
    Japan

    Site Not Available

  • Suita, Osaka
    Japan

    Site Not Available

  • Takatsuki, Osaka
    Japan

    Site Not Available

  • Toyonaka, Osaka
    Japan

    Site Not Available

  • Irima, Saitama
    Japan

    Site Not Available

  • empty

    Irima-gun, Saitama
    Japan

    Site Not Available

  • Fuji, Shizuoka
    Japan

    Site Not Available

  • Hamamatsu, Shizuoka
    Japan

    Site Not Available

  • Izunokuni, Shizuoka
    Japan

    Site Not Available

  • Shimono, Tochigi
    Japan

    Site Not Available

  • Yoshinogawa, Tokushima
    Japan

    Site Not Available

  • Bunkyo-ku, Tokyo
    Japan

    Site Not Available

  • Fuchu, Tokyo
    Japan

    Site Not Available

  • Kodaira, Tokyo
    Japan

    Site Not Available

  • Meguro-ku, Tokyo
    Japan

    Site Not Available

  • Nerima-ku, Tokyo
    Japan

    Site Not Available

  • Ota-ku, Tokyo
    Japan

    Site Not Available

  • Setagaya-ku, Tokyo
    Japan

    Site Not Available

  • Shibuya-ku, Tokyo
    Japan

    Site Not Available

  • Akita,
    Japan

    Site Not Available

  • Aomori,
    Japan

    Site Not Available

  • Fukuoka,
    Japan

    Site Not Available

  • Fukushima,
    Japan

    Site Not Available

  • Hiroshima,
    Japan

    Site Not Available

  • empty

    Hokkaido,
    Japan

    Site Not Available

  • empty

    Iwate,
    Japan

    Site Not Available

  • Kochi,
    Japan

    Site Not Available

  • Kyoto,
    Japan

    Site Not Available

  • Niigata,
    Japan

    Site Not Available

  • Okayama,
    Japan

    Site Not Available

  • Osaka,
    Japan

    Site Not Available

  • Tokushima,
    Japan

    Site Not Available

  • Toyama,
    Japan

    Site Not Available

  • Wakayama,
    Japan

    Site Not Available

  • Yamagata,
    Japan

    Site Not Available

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