Study summary

The objective of this study was to assess the efficacy of once-daily oral administration of gabapentin enacarbil versus placebo, based on the change in International Restless Legs Syndrome Rating Scale (IRLS) score in participants with moderate-to-severe idiopathic restless legs syndrome. This study also assessed the safety of Gabapentin enacarbil.

Additional Study Details

Phase
4
Product
  • Placebo
  • Gabapentin enacarbil
  • Type
    Interventional
    Masking
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Enrollment number
    375
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): Japanese
    Plain Language Summary
    Available Language(s): Japanese
    Protocol
    Available Language(s): English
    Statistical Analysis Plan (SAP)
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for A study of Oral Dosing of Gabapentin enacarbil in Japanese Restless Legs Syndrome Patients? Contact us by filling out your information to the right and we’ll respond to you.

    • A patient
    • A caregiver
    • A parent
    • A healthcare provider
    • A patient advocate
    • Algeria
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
    • Iceland
    • India
    • Indonesia
    • Ireland
    • Israel
    • Italy
    • Japan
    • Jordan
    • Kazakhstan
    • Latvia
    • Lebanon
    • Lithuania
    • Macedonia
    • Malaysia
    • Mexico
    • Montenegro
    • Morocco
    • Netherlands
    • New Zealand
    • Norway
    • Panama
    • Peru
    • Philippines
    • Poland
    • Portugal
    • Puerto Rico
    • Republic of Korea
    • Republic of Moldova
    • Romania
    • Russian Federation
    • Saudi Arabia
    • Serbia
    • Singapore
    • Slovakia
    • Slovenia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
    • Turkey
    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

    By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

      Locations

      Contact Us
      Contact Us
      Completed
      Site JP00031
      Chiba, Chiba, Japan
      Completed
      Site JP00025
      Nagoya, Aichi, Japan
      Completed
      Site JP00014
      Shinjuku, Tokyo, Japan
      Completed
      Site JP00043
      Tokorozawa, Saitama, Japan
      Completed
      Site JP00003
      Sapporo, Hokkaido, Japan
      Withdrawn
      Site JP00051
      Fukuoka, Fukuoka, Japan
      Completed
      Site JP00016
      Shinagawa, Tokyo, Japan
      Completed
      Site JP00035
      Kyoto, Kyoto, Japan
      Completed
      Site JP00020
      Kyoto, Kyoto, Japan
      Withdrawn
      Site JP00042
      Kyoto, Kyoto, Japan
      Completed
      Site JP00018
      Chuo, Tokyo, Japan
      Completed
      Site JP00010
      Osaka, Osaka, Japan
      Withdrawn
      Site JP00033
      Hirakata, Osaka, Japan
      Completed
      Site JP00026
      Osaka, Osaka, Japan
      Completed
      Site JP00029
      Nagoya, Aichi, Japan
      Completed
      Site JP00006
      Kitakyushu, Fukuoka, Japan
      Completed
      Site JP00039
      Osaka, Osaka, Japan
      Completed
      Site JP00037
      Osaka, Osaka, Japan
      Completed
      Site JP00002
      Sapporo, Hokkaido, Japan
      Completed
      Site JP00038
      Kawasaki, Kanagawa, Japan
      Completed
      Site JP00004
      Sapporo, Hokkaido, Japan
      Completed
      Site JP00019
      Ota, Tokyo, Japan
      Completed
      Site JP00023
      Sapporo, Hokkaido, Japan
      Terminated
      Site JP00049
      Yokohama, Kanagawa, Japan
      Completed
      Site JP00040
      Nagoya, Aichi, Japan
      Completed
      Site JP00028
      Chofu, Tokyo, Japan
      Completed
      Site JP00048
      Meguro, Tokyo, Japan
      Completed
      Site JP00012
      Arakawa, Tokyo, Japan
      Completed
      Site JP00024
      Chuo, Tokyo, Japan
      Completed
      Site JP00001
      Chofu, Tokyo, Japan
      Completed
      Site JP00046
      Nakano, Tokyo, Japan
      Completed
      Site JP00041
      Kawanishi, Hyogo, Japan
      Completed
      Site JP00011
      Shibuya, Tokyo, Japan
      Completed
      Site JP00009
      Yokosuka, Kanagawa, Japan
      Completed
      Site JP00030
      Saitama, Saitama, Japan
      Completed
      Site JP00032
      Sakai, Osaka, Japan
      Withdrawn
      Site JP00045
      Otaru, Hokkaido, Japan
      Completed
      Site JP00015
      Shinagawa, Tokyo, Japan
      Completed
      Site JP00022
      Kitakyushu, Fukuoka, Japan
      Completed
      Site JP00005
      Kobe, Hyogo, Japan
      Completed
      Site JP00013
      Shinagawa, Tokyo, Japan
      Completed
      Site JP00017
      Yokohama, Kanagawa, Japan
      Completed
      Site JP00008
      Shinjuku, Tokyo, Japan
      Completed
      Site JP00021
      Shinjuku, Tokyo, Japan
      Completed
      Site JP00047
      Osaka, Osaka, Japan
      Completed
      Site JP00034
      Musashino, Tokyo, Japan
      Completed
      Site JP00050
      Yokohama, Kanagawa, Japan
      Completed
      Site JP00044
      Saitama, Saitama, Japan
      Completed
      Site JP00036
      Fukuoka, Fukuoka, Japan
      Completed
      Site JP00007
      Yokohama, Kanagawa, Japan

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