The Effect of Gabapentin Enacarbil (GEn) on Mood Outcomes in Adult Patients With Moderate-to-Severe and Severe Primary Restless Legs Syndrome (RLS): Pooled Analyses from Three 12-Week Trials (P7.300)

OBJECTIVE: To determine the effect of GEn on mood in patients with moderate-to-severe and severe primary RLS. BACKGROUND: GEn (600 mg and 1200 mg once daily) significantly improved RLS symptoms vs placebo in adults with moderate-to-severe primary RLS in 3 trials (XP052, XP053, XP081). DESIGN/METHODS: Trial data were pooled. Mood was evaluated with Profile of Mood States (POMS) and International RLS (IRLS) Rating Scale 9 (daily affairs) and 10 (mood disturbance) changes from baseline to week 12. We evaluated the modified intent-to-treat population with moderate-to-severe (IRLS 蠅15) and severe (IRLS 蠅24) primary RLS. RESULTS: Patients were randomized to placebo (n=244), GEn 600 mg (n=161), and GEn 1200 mg (n=266). In the moderate-to-severe primary RLS population, least squares mean treatment differences were significant ( P P P P <.01. CONCLUSIONS: GEn 1200 mg significantly improved mood vs placebo in this pooled analysis of patients with moderate-to-severe and severe primary RLS. GEn 600 mg significantly improved vigor/activity only in the moderate-to-severe primary RLS group. Within each study, the most common treatment-emergent adverse events were somnolence and dizziness. Disclosure: Dr. Lee has nothing to disclose. Dr. Park has nothing to disclose. Dr. Kreitzman has received personal compensation for activities with Acadia Pharmaceuticals, UCB Pharma, Impax, Teva Neuroscience, Xenoport, US WorldMeds, and Lundbeck Research USA, Inc. as a consultant. Dr. Ellenbogen has received personal compensation for activities with XenoPort, Inc., Teva, Boehringer Ingelheim, Allergan, Inc., and Novartis. Dr. Jaros has received personal compensation for activities with XenoPort, Inc. as an employee. Dr. Kim has received personal compensation for activities with XenoPort, Inc. as an employee. Dr. Shang has received personal compensation for activities with XenoPort, Inc. as an employee.