Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance

NCT ID: NCT00748098

Last Updated: 2013-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-07-31

Brief Summary

The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.

Detailed Description

Double-blind, multi-center, placebo-controlled, 2-period crossover study which assessed the efficacy and safety of gabapentin enacarbil (GEn; GSK1838262; XP13512) extended release tablets in adults with Restless Legs Syndrome (RLS)-associated sleep disturbance. One hundred thirty-six (136) adult subjects with RLS-associated sleep disturbance and periodic limb movements (PLM) were randomized from 23 centers in the United States. Subjects who met all eligibility criteria were randomized to receive a treatment sequence of GEn:placebo or placebo:GEn. Investigational product was taken with food at approximately 5pm. Investigational product was dosed as 600mg/day x3 days followed by 1200mg/day x25 days for each 4-week treatment period. There was a 1-week taper at 600mg after each treatment period followed by a 1-week washout between treatments. Polysomnography (PSG) was used to objectively evaluate changes in sleep and PLMs.

Conditions

Restless Legs Syndrome; Restless Legs Syndrome (RLS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

GSK1838262:placebo

GSK1838262 extended release tablets for Treatment Period 1 followed by Placebo for Treatment Period 2

Group Type: OTHER

Placebo

Intervention Type: DRUG

Placebo

Placebo:GSK1838262

Placebo for Treatment Period 1 followed by GSK1838262 for Treatment Period 2

Group Type: OTHER

GSK1838262 Extended Release Tablets

Intervention Type: DRUG

GSK1838262 extended release tablets

Interventions

GSK1838262 Extended Release Tablets

GSK1838262 extended release tablets

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

XP13512; gabapentin enacarbil

Eligibility Criteria

Inclusion Criteria

• Provided written informed consent.
• Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
• Have history of RLS symptoms at least 15 nights/month.
• Minimum average of 15 Periodic Limb Movements during Sleep per hour (measured using actigraphy).

Exclusion Criteria

• Secondary RLS
• Primary sleep disorder
• Sleep apnea
• Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
• Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
• Use of any prohibited medication.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

XenoPort, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Jasper, Alabama, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Hallandale, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Macon, Georgia, United States

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Overland Park, Kansas, United States

GSK Investigational Site

Crestview Hills, Kentucky, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

Chevy Chase, Maryland, United States

GSK Investigational Site

Brighton, Massachusetts, United States

GSK Investigational Site

Kalamazoo, Michigan, United States

GSK Investigational Site

West Seneca, New York, United States

GSK Investigational Site

Greenville, North Carolina, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Dublin, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Columbia, South Carolina, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Walla Walla, Washington, United States

Countries

United States

References

Calloway M, Bharmal M, Hill-Zabala C, Allen R. Development and validation of a subjective post sleep diary (SPSD) to assess sleep status in subjects with restless legs syndrome. Sleep Med. 2011 Aug;12(7):704-10. doi: 10.1016/j.sleep.2010.09.020. Epub 2011 Jul 5.

Reference Type: BACKGROUND

PMID: 21733752 (View on PubMed)

Other Identifiers

RXP110908

Identifier Type: -

Identifier Source: org_study_id