Last updated: 11/07/2018 03:30:37

XP13512 Extension Study in Patients With Restless Legs Syndrome.

GSK study ID
111490
See study documents
Clinicaltrials.gov ID
NCT00333359
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: An Open-Label, 52-Week Extension Study Assessing XP13512 Safety and Efficacy in Patients With Restless Legs Syndrome.
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

International Restless Legs Syndrome (IRLS) rating scale score.

Timeframe: 52 weeks

Incidence of adverse events

Timeframe: 52 weeks

Investigator-rated Clinical Global Impression (CGI) of Improvement.

Timeframe: 52 weeks

Secondary outcomes:

Work Productivity and Activity Impairment Questionnaire: Specific Health Problem.

Timeframe: 52 weeks

RLS Quality of Life Scale.

Timeframe: 52 weeks

Interventions:
  • Drug: XP13512 (GEn)
    • Enrollment:
    581
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Ellenbogen A, Thein S, Winslow D, Becker P, Tolson J, Lassauzet M-L, Chen D. A 52-week study of gabapentin enacarbil in Restless Legs Syndrome. Clin Neuropharmacol. 2011;34(1):8-16.
    Medical condition
    Restless Legs Syndrome
    Product
    gabapentin enacarbil
    Collaborators
    Not applicable
    Study date(s)
    June 2006 to December 2008
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Inclusion Criteria:
    • Patients who have successfully completed one of the following studies: XP052 (110963 [NCT00298623]), XP053 (111460 [NCT00365352]), XP081 (111462 [NCT01332305]), and XP083 (111463 [NCT01332318]).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Patients who have successfully completed one of the following studies: XP052 (110963 [NCT00298623]), XP053 (111460 [NCT00365352]), XP081 (111462 [NCT01332305]), and XP083 (111463 [NCT01332318]).

    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
    2008-02-12

    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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