Last updated: 11/03/2018 16:02:22

A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group Study to Compare the Efficacy, Tolerability, and Safety of 3 Doses of Gabapentin Enacarbil (GSK1838262) With Placebo in the Treatment of Subjects With Moderate-to-Severe Primary Restless Legs Syndrome (RLS)CONCORD

GSK study ID
114025
See study documents
Clinicaltrials.gov ID
NCT01668667
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, Fixed-Dose, Parallel-Group Study to Compare the Efficacy, Tolerability, and Safety of 3 Doses of Gabapentin Enacarbil (GSK1838262) With Placebo in the Treatment of Subjects With Moderate-to-Severe Primary Restless Legs Syndrome (RLS)
Trial description: Gabapentin enacarbil (GEn; GSK1838262; HORIZANT), at a dose of 600 mg/day, is currently approved in the United States for the treatment of adults with moderate-to-severe primary Restless Legs Syndrome (RLS). The aim of this study is to compare the efficacy, tolerability, and safety of GEn at lower doses (450 and 300 mg/day) as well as the already approved dose of 600 mg/day versus placebo for the treatment of subjects with moderate to severe primary RLS. This study is being conducted as a post-marketing commitment (PMC) as a condition of the approval of HORIZANT tablets (NDA 022399).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

• The change from Baseline to the end of treatment in the International Restless Legs Syndrome (IRLS) Rating Scale score

Timeframe: 12 weeks

• The proportion of subjects at the end of treatment who are responders with either “much improved” or “very much improved” on the investigator-rated Clinical Global Impression of Improvement (CGI-I)

Timeframe: 12 weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: gabapentin enacarbil GEn 600 mg
  • Drug: Placebo to match 600 mg, 450 mg, 300 mg
  • Drug: gabapentin enacarbil GEn 300 mg
  • Drug: gabapentin enacarbil GEn 450 mg
    • Enrollment:
    501
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Restless Legs Syndrome
    Product
    gabapentin enacarbil
    Collaborators
    Not applicable
    Study date(s)
    June 2012 to November 2013
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    None
    • Men or women 18 years of age or older
    • History of RLS symptoms for at least 15 nights/month
    • History of a sleep disorder that may affect the assessment of RLS
    • History of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Men or women 18 years of age or older
    • History of RLS symptoms for at least 15 nights/month
    • Documented RLS symptoms, using the 7-day RLS Symptom Record, for at least 4 of the 7 consecutive evenings/nights during the night -Total RLS severity score of 15 or greater on the International RLS (IRLS) Rating Scale at Visit 1 and at Visit 2
    • Discontinuation of dopamine agonists and/or gabapentin , or other treatments for RLS (e.g. opioids, benzodiazepines) at least 2 weeks prior to Baseline
    • If taking any prescription medication, therapy must have been stabilized for at least 3 months prior to Screening with no anticipated changes for the duration of the study
    • Female subjects are eligible if of non-childbearing potential or not lactating, has a negative pregnancy, and agrees to use a highly effective method for avoiding pregnancy
    • Body mass index of 34 or below
    • Estimated creatinine clearance of ≥60 mL/min
    • Provides written consent in accordance with all applicable regulatory requirements
    Exclusion criteria:
    • History of a sleep disorder that may affect the assessment of RLS -History of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment -Neurologic disease or movement disorder -Other medical conditions or drug therapy that could affect RLS efficacy assessments or may present a safety concern -Have clinically significant or unstable medical conditions -Have active suicidal plan/intent or has had active suicidal thoughts in the past 6 months; has a history of suicide attempt

    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
    2013-14-11

    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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