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
N/A
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 caregiver
  • A healthcare provider
  • A parent
  • A patient
  • 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

    Frequently Asked Questions

    Are clinical trials only for people with advanced cancer?

    While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

    Will I have to stop my current treatment to participate in a clinical trial?

    Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

    Should I be worried about getting a placebo?

    In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

    Do I need a referral from my doctor to take part in a study?

    Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

    Explore More

    1

    What are clinical trials?

    2

    Why are Clinical Trials Important?

    3

    Why Participate in a Clinical Trial?