• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » RLS Drug Shows Promise in Pivotal Trial

RLS Drug Shows Promise in Pivotal Trial

March 11, 2008
CenterWatch Staff

XenoPort and GlaxoSmithKline reported positive top-line results from a phase III trial of XP13512, a gabapentin pro-drug with enhanced absorption, for the treatment of moderate to severe restless legs syndrome. This 12-week, double-blind, placebo-controlled study, dubbed XP053, enrolled 325 subjects. The endpoints were met with statistical significance in both dose groups when compared to placebo.

The subjects received placebo or 600 mg or1, 200 mg of XP13512, given once per day. The primary endpoints were the change from baseline for the International Restless Legs Syndrome (IRLS) rating scale score at end of treatment and the percentage of subjects showing significant improvement on the Investigator Clinical Global Impression of Improvement (CGI-I) scale at end of treatment.

In the 600 mg dose group, the unadjusted mean reduction in the IRLS scale score was -13.8 (p less than 0.0001). 

At the end of treatment, 73% of subjects treated with 600 mg of XP13512 were reported as “much improved” or “very much improved” on the CGI-I scale (p less than 0.0001 compared with placebo). In the 1,200 mg dose group, the unadjusted mean reduction in the IRLS scale score was -13.0 versus -9.8 for placebo (p=0.0015).

At the end of treatment, 78% of subjects treated with 1,200 mg XP13512 were reported as “much improved” or “very much improved” on the CGI-I scale compared with 45% treated with placebo (p less than 0.0001). Treatment was generally well tolerated, with adverse events mild to moderate.

An New Drug Application (NDA) filing is planned for the third quarter of this year.

In February 2007, GlaxoSmithKline and XenoPort entered into an exclusive development and commercialization collaboration for the drug.

Upcoming Events

  • 15Apr

    Five Telltale Signs You’re Ready for an Electronic TMF System

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

  • 06May

    The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

Featured Products

  • Regenerative Medicine – Steps to Accelerate Development : PDF

    Regenerative Medicine: Steps to Accelerate Development

  • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

    Clinical Trial Agreements: A Guide to Key Words and Phrases

Featured Stories

  • Clinical-Trial-Brainstorming

    FDA, Industry Tackle Problem of Including Older Adults in Trials

  • ClinicalTrialNetwork-360x240.png

    National Community-Based Research Network Would Improve Reach of Trials

  • Bottleneck-360x240.png

    Sites Face Trials Bottleneck After Pandemic, But Also Opportunities

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Genetic Research and IBC Oversight Requirements

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing