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

Completed · Phase 4 · Has a placebo group

Conditions studied: Restless Legs Syndrome

In brief

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).

Key facts

Study ID

NCT01668667

Run by

XenoPort, Inc.

People needed

501

Starts

2012-06-01

Expected to finish

2013-11-01

Last updated by the study team

2021-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Santa Monica, California, United States
• GSK Investigational Site — Colorado Springs, Colorado, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — DeLand, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Woodstock, Georgia, United States
• GSK Investigational Site — Lenexa, Kansas, United States
• GSK Investigational Site — Topeka, Kansas, United States
• GSK Investigational Site — Crestview Hills, Kentucky, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Metairie, Louisiana, United States
• GSK Investigational Site — Chevy Chase, Maryland, United States
• GSK Investigational Site — Bingham Farms, Michigan, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Albuquerque, New Mexico, United States
• GSK Investigational Site — Hickory, North Carolina, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Winston-Salem, North Carolina, United States
• GSK Investigational Site — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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