NCT00333359

Brief Summary

The primary objective of this trial is to assess the long-term safety and efficacy of XP13512 (Gabapentin Enacarbil) taken once daily 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
581

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2006

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

June 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

June 23, 2011

Completed
Last Updated

July 22, 2013

Status Verified

May 1, 2011

Enrollment Period

2.5 years

First QC Date

June 1, 2006

Results QC Date

April 28, 2011

Last Update Submit

July 15, 2013

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC)

    The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the Week 52 value minus the baseline value. Change scores with higher value represents greater improvement in RLS symptoms.

    Baseline and Week 52

  • Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC

    The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being "very much improved" and a score of 7 being "very much worse" compared to the start of the study. Responders on the CGI-I are defined as those with a score of 1 or 2, corresponding to "very much improved" or "improved," respectively.

    Weeks 0, 1, 4, 12, 24, 36, and 52

Secondary Outcomes (10)

  • Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC

    Weeks 0, 1, 4, 12, 24, and 36

  • Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC

    Weeks 0, 1, and 52

  • Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC

    Weeks 0, 1, 4, 12, 24, 36, and 52

  • Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC

    Weeks 0, 1, and 52

  • Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data

    Week 52

  • +5 more secondary outcomes

Study Arms (1)

XP13512 (GEn)

EXPERIMENTAL

1200 mg XP13512, orally, once daily for 52 weeks

Drug: XP13512 (GEn)

Interventions

XP13512 (GEn)DRUG

1200 mg XP13512, orally, once daily for 52 weeks

Also known as: GSK1838262, Gabapentin Enacarbil
XP13512 (GEn)

Eligibility Criteria

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

You may qualify if:

  • Patients who have successfully completed one of the following studies: XP052 (110963 \[NCT00298623\]), XP053 (111460 \[NCT00365352\]), XP081 (111462 \[NCT01332305\]), and XP083 (111463 \[NCT01332318\]).

You may not qualify if:

  • Subjects who, in the opinion of the Investigator, would be non-compliant with the study visit schedule, procedures, or medication administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ellenbogen AL, Thein SG, Winslow DH, Becker PM, Tolson JM, Lassauzet ML, Chen D. A 52-week study of gabapentin enacarbil in restless legs syndrome. Clin Neuropharmacol. 2011 Jan-Feb;34(1):8-16. doi: 10.1097/WNF.0b013e3182087d48.

    PMID: 21242741BACKGROUND

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 5, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 22, 2013

Results First Posted

June 23, 2011

Record last verified: 2011-05