NCT00748098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 18, 2011

Completed
Last Updated

July 22, 2013

Status Verified

January 1, 2013

Enrollment Period

9 months

First QC Date

September 5, 2008

Results QC Date

April 21, 2011

Last Update Submit

July 15, 2013

Conditions

Restless Legs SyndromeRestless Legs Syndrome (RLS)

Keywords

PSGRestless Legs Syndromegabapentin enacarbilXP13512GSK1838262sleep disturbanceRLSpolysomnography

Outcome Measures

Primary Outcomes (1)

  • Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward (LOCF)

    PSG is a comprehensive recording of the bio-physiological changes that occur during sleep. It is also known as a "sleep study" that monitors participants as they sleep or try to sleep. WTDS, defined as the total amount of time spent awake after falling asleep until the last awakening, was measured by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

    Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Secondary Outcomes (27)

  • Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF

    Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

  • Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF

    Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

  • Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF

    Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

  • Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF

    Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

  • Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N1 Sleep Stage at Week 4/10 Using LOCF

    Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

  • +22 more secondary outcomes

Study Arms (2)

GSK1838262:placebo

OTHER

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

Drug: Placebo

Placebo:GSK1838262

OTHER

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

Drug: GSK1838262 Extended Release Tablets

Interventions

GSK1838262 Extended Release TabletsDRUG

GSK1838262 extended release tablets

Also known as: XP13512, gabapentin enacarbil
Placebo:GSK1838262
PlaceboDRUG

Placebo

GSK1838262:placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

GSK Investigational Site

Jasper, Alabama, 35501, United States

Location

GSK Investigational Site

San Diego, California, 92103, United States

Location

GSK Investigational Site

San Diego, California, 92121, United States

Location

GSK Investigational Site

Hallandale, Florida, 33009, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30342, United States

Location

GSK Investigational Site

Macon, Georgia, 31201, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66214, United States

Location

GSK Investigational Site

Overland Park, Kansas, 66211, United States

Location

GSK Investigational Site

Crestview Hills, Kentucky, 41017, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40509, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21224, United States

Location

GSK Investigational Site

Chevy Chase, Maryland, 20815, United States

Location

GSK Investigational Site

Brighton, Massachusetts, 02135, United States

Location

GSK Investigational Site

Kalamazoo, Michigan, 49048, United States

Location

GSK Investigational Site

West Seneca, New York, 14224, United States

Location

GSK Investigational Site

Greenville, North Carolina, 27835, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27612, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45245, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44130, United States

Location

GSK Investigational Site

Dublin, Ohio, 43017, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

GSK Investigational Site

Columbia, South Carolina, 29201, United States

Location

GSK Investigational Site

Austin, Texas, 78756, United States

Location

GSK Investigational Site

Walla Walla, Washington, 99362, United States

Location

Related Publications (1)

  • 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.

    PMID: 21733752BACKGROUND

MeSH Terms

Conditions

Restless Legs SyndromeParasomnias

Interventions

1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Results Point of Contact

Title
XenoPort Call Center
Organization
XenoPort, Inc.
877-936-6778

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 8, 2008

Study Start

October 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

July 22, 2013

Results First Posted

May 18, 2011

Record last verified: 2013-01

Locations

US(24)