Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XenoPort, Inc.
• Treatments: Gabapentin; gamma-Aminobutyric Acid

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