Last updated: 11/07/2018 03:10:42

XP13512 Versus Placebo in Patients With Restless Legs Syndrome.

GSK study ID
110963
See study documents
Clinicaltrials.gov ID
NCT00298623
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

The proportion of subjects at the end of treatment who are “much improved” or “very much improved” on the Investigator-rated CGI of Improvement

Timeframe: 12-week treatment period

The change from baseline to the end of treatment in International Restless Legs Syndrome (IRLS) rating scale score.

Timeframe: 12-week treatment period

Secondary outcomes:

Onset of efficacy. Subjective measures of sleep.

Timeframe: 12-week treatment period

Interventions:
  • Drug: XP13512 (GSK1838262)
  • Other: placebo
    • Enrollment:
    222
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Daniel Canafax; Abhijeet Bhanegaonkar; Murtuza Bharmal; Michael Calloway. Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials. BMC Neurology. 2011;11(48):
    Kushida CA, Becker PM, Ellenbogen AL, Canafax DM, Barrett R. A randomized, double-blind, placebo-controlled trial of XP13512/GSK1838262 in restless legs syndrome. Neurology. 2009;72:439 - 446.
    R Bogan, A Ellenbogen, P Becker, C Kushida, E Ball, W Ondo, C Caivano, S Kavanagh. Gabapentin Enacarbil in Subjects with Moderate-to-Severe Primary Restless Legs Syndrome with and without Severe Sleep Disturbance: An Integrated Analysis of Subjective and Novel Sleep Endpoints from Two Studies. J Parkinsonism RLS. 2013;3:31-40.
    Samantha Warren, Sarah Kavanagh, Susan VanMeter, Ron Barrett. Comparison of Multiple Doses of Gabapentin Enacarbil versus Placebo in Subjects with Moderate-to-Severe Primary Restless Legs Syndrome: An Integrated Analysis of Three 12-Week Studies. CNS Drugs. 2012;26(9):773-780.
    Medical condition
    Restless Legs Syndrome
    Product
    gabapentin enacarbil
    Collaborators
    Not applicable
    Study date(s)
    March 2006 to February 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Patients with primary RLS, based on the International RLS Study Group Diagnostic Criteria.
    • History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started;
    • 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,
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients with primary RLS, based on the International RLS Study Group Diagnostic Criteria.
    • History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started;
    • Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights during the Baseline study period;
    • Total RLS severity score of 15 or greater on the International Restless Legs Syndrome Study Group Rating Scale (IRLS rating scale) at Visit 1 and at Visit 2;
    • Discontinuation of dopamine agonists and/or gabapentin at least 2 weeks prior to Baseline;
    • Discontinuation of other treatments for RLS (e.g., opioids, benzodiazepines) at least 2 weeks prior to Baseline;
    • If female of child-bearing potential, the subject must agree to use clinically accepted birth control through completion of the study;
    • Body Mass Index of 34 or below;
    • Estimated creatinine clearance of at least 60 mL/min;
    Exclusion criteria:
    • 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-22-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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