Last updated on April 2013

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)


Brief description of study

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)

Detailed Study Description

Patient Inclusion Criteria:

  • Ages 18+
  • RLS diagnosis
  • 15 nights or more in past month with RLS symptoms
  • Must stop all RLS medications 2 weeks prior
  • No Horizant usage in past
  • 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

Patient 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

Clinical Study Identifier: TX136795

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