my personal edition > restless legs syndrome > news


  E-Mail this DGDispatch to a colleague

DGDispatch

Gabapentin Enacarbil Improves Functioning, Quality of Life, and Mood in Patients With Primary Restless Legs Syndrome: Presented at MDS

By Jenny Powers

PARIS -- June 12, 2009 -- Gabapentin enacarbil was effective in improving symptoms in patients with primary restless legs syndrome (RLS), and also was well tolerated, according to investigators reporting here at the Movement Disorder Society's (MDS) 13th International Congress of Parkinson's Disease and Movement Disorders.

Lead investigator Sarah E. DeRosset MD, PhD, Glaxo Smith Kline, Research Triangle Park, North Carolina, and colleagues evaluated the effects of gabapentin enacarbil on RLS symptoms, mood, quality of life, and functioning in a 12-week, double-blind, placebo-controlled, multicentre study. They presented their findings here on June 9.

Two hundred twenty-two subjects who had moderate to severe primary RLS were enrolled in this study. The subjects were randomised to gabapentin enacarbil 1,200 mg (n = 114) or placebo (n = 108) once daily at 5:00 PM with food.

The study endpoints were mean change from baseline in International Restless Legs Scale (IRLS) total score and the proportion of responders (rated "very much" or "much" improved) on the investigator-rated Clinical Global Impression-Improvement scale. Mood, quality of life, and functioning were assessed using the Profile of Mood State (POMS) and a Mood Assessment Question (MAQ), the Johns Hopkins Restless Legs Syndrome Quality of Life (RLS-QOL) questionnaire, and item 2 (ability to function in the past week) of the Post-Sleep Questionnaire (PSQ).

Treatment with gabapentin enacarbil resulted in a significantly improved mean IRLS total score versus placebo at week 12 last observation carried forward compared with baseline (adjusted mean treatment difference [AMTD] for change from baseline: -4.0 [P = .0003]).

Treatment with gabapentin enacarbil also improved the POMS total mood disturbance score from baseline (AMTD: -6.9 [P = .014]); overall mood measured by MAQ (P = .0008); mean RLS-QOL overall life impact score (AMTD [standard error]: 7.8 [1.86]; [P < .0001]); and ability to function as measured by PSQ, item 2 (P = .0002) all versus placebo at week 12 last observation carried forward.

Subjects treated with gabapentin enacarbil reported sleepiness more frequently than did those who received placebo (27% vs 7%). Dizziness also was reported more often in the gabapentin enacarbil group than in the placebo group (19% vs 5%).

No clinically significant changes were detected in vital signs, electrocardiograms, or laboratory parameters.

The authors concluded that treatment with gabapentin enacarbil 1,200 mg once daily significantly improves RLS symptoms and is well tolerated.

Funding for this study was provided by GlaxoSmithKline.

[Presentation title: Once Daily Gabapentin Enacarbil Improves Quality of Life and Ability to Function for Patients With Primary Restless Legs Syndrome. Abstract TU-424]

E-Mail this DGDispatch to a colleague

To print, use this version