NCT00311363

Brief Summary

The primary objective of this trial is to assess the maintenance of efficacy of gabapentin enacarbil (GEn, XP13512) taken once daily in the long-term 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
327

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 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

Study Start

First participant enrolled

April 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

May 25, 2011

Completed
Last Updated

July 22, 2013

Status Verified

May 1, 2011

Enrollment Period

1.6 years

First QC Date

April 3, 2006

Results QC Date

April 28, 2011

Last Update Submit

July 15, 2013

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period

    Relapse was defined as worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week double-blind (DB) treatment period (the period from Randomization on Visit 14 \[Week 24\] through the end of treatment). Worsening of symptoms was defined as an increase in the total International RLS (IRLS) Scale score by at least 6 or more points relative to the participant's score at Randomization, achieving an IRLS score of at least 15, and an assessment of "much worse" or "very much worse" on the investigator-rated Clinical Global Impression of Change (CGI-C).

    DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)

Secondary Outcomes (32)

  • Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period

    DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)

  • Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period (Excluding First Two Weeks of DB Phase)

    DB Treatment Period; Days 184 to 252 (Weeks 26 to 36)

  • Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF)

    Randomization (Week 24) and Week 36 (or end of DB treatment)

  • Percentage of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated Clinical Global Impression of Change (CGI-C) Scale as a Dichotomous Variable at Week 36 (DB Treatment Phase) Using LOCF

    Randomization (Week 24) and Week 36 (or end of DB treatment)

  • Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF

    Randomization (Week 24) and Week 36 (or end of DB treatment)

  • +27 more secondary outcomes

Study Arms (2)

GEn (XP13512) 1200 mg

EXPERIMENTAL

GEn (XP13512) 1200 mg

Drug: GEn (XP13512)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

GEn (XP13512)DRUG

1200 mg GEn (XP13512) orally, once daily for 24 weeks followed by either 1200 mg GEn (XP13512) or placebo, orally, once daily for an additional 12 weeks

Also known as: Gabapentin Enacabil, XP13512
GEn (XP13512) 1200 mg
PlaceboDRUG

Placebo, orally, once daily for 12 weeks following single blind 24-week phase

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 Group 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 (1)

  • Bogan RK, Bornemann MA, Kushida CA, Tran PV, Barrett RW; XP060 Study Group. Long-term maintenance treatment of restless legs syndrome with gabapentin enacarbil: a randomized controlled study. Mayo Clin Proc. 2010 Jun;85(6):512-21. doi: 10.4065/mcp.2009.0700.

    PMID: 20511481BACKGROUND

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

April 3, 2006

First Posted

April 5, 2006

Study Start

April 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

July 22, 2013

Results First Posted

May 25, 2011

Record last verified: 2011-05