NCT00365352

Brief Summary

The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
325

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

August 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

May 11, 2011

Completed
Last Updated

July 22, 2013

Status Verified

May 1, 2011

Enrollment Period

1.3 years

First QC Date

August 15, 2006

Results QC Date

April 21, 2011

Last Update Submit

July 15, 2013

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF)

    The International Restless Legs Syndrome (IRLS) Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.

    Baseline and Week 12

  • Number of Participants With a Score of "Much Improved" or "Very Much Improved" on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF

    The investigator -rated Clinical Global Impression of Improvement (CGI-I) scale is an assessment designed to allow investigators to rate the change of a participant's disease severity over time based on a seven-point scale, with a score of 1 being "very much improved," a score of 2 being "much improved," a score of 3 being "minimally improved," a score of 4 being "no change," a score of 5 being "minimally improved,"a score of 6 being "much worse," and a score of 7 being "very much worse." Participants with a response of "much improved" or "very much improved" were classified as responders.

    Week 12

Secondary Outcomes (25)

  • Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF

    Baseline (Day 1) and End of Treatment (Week 12)

  • Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF

    Week 12

  • Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF

    End of Week 1

  • The Time to Onset of the First Response to Treatment on the IRLS Rating Scale Total Score and the Investigator-rated CGI-I

    Baseline (Day 1) to End of Treatment (Week 12)

  • Mean Change in the IRLS Rating Scale Total Score From Baseline at Week 12 by RLS Treatment History Using LOCF

    Baseline (Day 1) and Week 12

  • +20 more secondary outcomes

Study Arms (3)

XP13512 600MG

EXPERIMENTAL

XP13512 600MG ONCE DAILY

Drug: XP13512 600MG

XP13512 1200MG

EXPERIMENTAL

XP13512 1200MG ONCE DAILY

Drug: XP13512 1200MG

Placebo

PLACEBO COMPARATOR

PLACEBO ONCE DAILY

Drug: PLACEBO

Interventions

XP13512 600MGDRUG

XP13512 600MG ONCE DAILY

Also known as: GSK1838262, Gabapentin Enacarbil
XP13512 600MG
XP13512 1200MGDRUG

XP13512 1200MG ONCE DAILY

Also known as: GSK1838262, Gabapentin Enacarbil
XP13512 1200MG
PLACEBODRUG

PLACEBO ONCE DAILY

Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients with primary RLS, based on the International RLS Study Diagnostic Criteria.

You may not qualify if:

  • A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
  • Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias, and dystonias);
  • Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
  • Pregnant or lactating women;
  • Women of childbearing potential who are not practicing an acceptable method of birth control.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Ahmed M, Hays R, Steven Poceta J, Jaros MJ, Kim R, Shang G. Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials. Clin Ther. 2016 Jul;38(7):1726-1737.e1. doi: 10.1016/j.clinthera.2016.05.008. Epub 2016 Jun 7.

    PMID: 27288210DERIVED

  • Avidan AY, Lee D, Park M, Jaros MJ, Shang G, Kim R. The Effect of Gabapentin Enacarbil on Quality of Life and Mood Outcomes in a Pooled Population of Adult Patients with Moderate-to-Severe Primary Restless Legs Syndrome. CNS Drugs. 2016 Apr;30(4):305-16. doi: 10.1007/s40263-016-0329-4.

    PMID: 27067343DERIVED

  • Ondo WG, Hermanowicz N, Borreguero DG, Jaros MJ, Kim R, Shang G. Effect of prior exposure to dopamine agonists on treatment with gabapentin enacarbil in adults with moderate-to-severe primary restless legs syndrome: pooled analyses from 3 randomized trials. J Clin Mov Disord. 2015 Mar 30;2:9. doi: 10.1186/s40734-015-0018-3. eCollection 2015.

    PMID: 26788345DERIVED

  • Lee DO, Ziman RB, Perkins AT, Poceta JS, Walters AS, Barrett RW; XP053 Study Group. A randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with restless legs syndrome. J Clin Sleep Med. 2011 Jun 15;7(3):282-92. doi: 10.5664/JCSM.1074.

    PMID: 21677899DERIVED

  • Canafax DM, Bhanegaonkar A, Bharmal M, Calloway M. Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials. BMC Neurol. 2011 Apr 28;11:48. doi: 10.1186/1471-2377-11-48.

    PMID: 21527006DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

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

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental 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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2006

First Posted

August 17, 2006

Study Start

August 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

July 22, 2013

Results First Posted

May 11, 2011

Record last verified: 2011-05