Format

Send to

Choose Destination
Sleep Med. 2016 Mar;19:50-6. doi: 10.1016/j.sleep.2015.11.002. Epub 2015 Nov 14.

Efficacy of gabapentin enacarbil in adult patients with severe primary restless legs syndrome.

Author information

1
Baptist Health Neurology, 789 Eastern Bypass Suite 16, Richmond, KY 40475, USA. Electronic address: daniel.lee@bhsi.com.
2
Stanford University Medical Center, 300 Pasteur Drive, Stanford, CA 94305, USA.
3
Sleep Research Institute, Alberto Alcocer 19, 28036 Madrid, Spain.
4
UCLA Sleep Disorders Center, Department of Neurology, David Geffen School of Medicine at UCLA, 710 Westwood Boulevard, Los Angeles, CA 90095, USA.
5
Cleveland Sleep Research Center, 17900 Jefferson Park Road, Suite 102, Middleburg Heights, OH 44130, USA.
6
University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-8508, USA.
7
University of Texas Health Science Center at Houston, 6410 Fannin Street, Suite 1010, Houston, TX 77030, USA.
8
Summit Analytical, LLC, 2422 Stout Street, Denver, CO 80205, USA.
9
XenoPort, Inc., 3410 Central Expressway, Santa Clara, CA 95051, USA.

Abstract

AIM:

Assess efficacy and tolerability of gabapentin enacarbil (GEn) in adults with severe primary restless legs syndrome (RLS).

METHODS:

We pooled data from three 12-week, double-blind, placebo-controlled, randomized trials (NCT00298623, NCT00365352, NCT01332305) across GEn 600-mg, GEn 1200-mg, and placebo treatment groups for severe primary RLS (baseline International Restless Legs Scale (IRLS) total score ≥24). Co-primary end points at week 12 were mean change from baseline in IRLS total score and proportion of responders ("much"/very much" improved) on the investigator-rated Clinical Global Impression - Improvement (CGI-I) Scale. Outcomes for individual IRLS items (eg, sleep, mood, quality of life, pain, safety) were assessed.

RESULTS:

A total of 309 patients had severe primary RLS (placebo, n = 110; GEn 600 mg, n = 80; GEn 1200 mg, n = 119). GEn 600 mg and 1200 mg significantly improved least-squares mean IRLS total scores versus placebo at week 12 (placebo, -12.3; GEn 600 mg, -16.3; GEn 1200 mg, -18.0; treatment difference vs. placebo, both p <0.01). Significantly more patients with severe primary RLS treated with GEn 600 mg (64%) and 1200 mg (74%) were CGI-I responders at week 12 versus placebo (42%; p <0.01 for both GEn doses). Both GEn doses led to significant improvements in the other outcomes explored versus placebo at week 12. The most frequent treatment-emergent adverse events (TEAEs) were somnolence (GEn, 21-24%; placebo, 3%) and dizziness (GEn, 14-19%; placebo, 3%).

CONCLUSIONS:

GEn (600 mg or 1200 mg) once daily significantly improved RLS symptoms and consequences of these symptoms in severe primary RLS. The most frequent TEAEs were somnolence and dizziness.

KEYWORDS:

Clinical Global Impression − Improvement; Gabapentin enacarbil; International Restless Legs Scale; Mood; Restless legs syndrome; Sleep

PMID:
27198947
DOI:
10.1016/j.sleep.2015.11.002
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center