Last updated: 11/07/2018 18:14:20

Polysomnography study of GSK1838262 (XP13512) extended release tablets versus placebo in Restless Legs Syndrome (RLS) and associated sleep disturbance

GSK study ID
RXP110908
See study documents
Clinicaltrials.gov ID
NCT00748098
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: Study RXP110908, a polysomnography study of GSK1838262 (XP13512) extended release tablets versus placebo in the treatment of Restless Legs Syndrome (RLS) and associated sleep disturbance
Trial description: The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Change from baseline to end of each treatment period in Wake Time During Sleep (WTDS) measured by polysomnography

Timeframe: 4 weeks

Secondary outcomes:

Change from baseline to end of each treatment period in Periodic Limb Movements associated with Arousal per hour (PLMAI) measured by polysomnography

Timeframe: 4 weeks

Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.

Timeframe: 4 weeks

Interventions:
  • Drug: Placebo
  • Drug: GSK1838262 Extended Release Tablets
    • Enrollment:
    136
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    J. Winkelman, R. Bogan, M. Schmidt, J. Hudson, S. DeRossett, C. Hill-Zabala. A randomized, placebo-controlled polysomnography study of gabapentin enacarbil in subjects with RLS. [Mov Disord]. 2011;26(11):2065-2072.
    M Calloway; M Bharmal; C Hill-Zabala; R Allen. Development and Validation of a Subjective Post Sleep Diary to Assess Sleep Status in Subjects with Restless Legs Syndrome . [Sleep Med]. 2011;DOI 10.1016(/j.sleep.):2010.09.020.
    Medical condition
    Restless Legs Syndrome
    Product
    gabapentin enacarbil
    Collaborators
    Not applicable
    Study date(s)
    October 2008 to July 2009
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Inclusion criteria:
    • Provided written informed consent.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Provided written informed consent.
    • Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
    • Have history of RLS symptoms at least 15 nights/month.
    • Minimum average of 15 Periodic Limb Movements during Sleep per hour (measured using actigraphy). Exclusion criteria:
    • Secondary RLS
    • Primary sleep disorder
    • Sleep apnea
    • Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
    • Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
    • Use of any prohibited medication.

    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
    2009-22-07

    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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