Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome

Summary

This is a phase IV single-blind, placebo run-in fixed dose single-group study to assess objective and subjective effects of GEn on sleep EEG, BP, and anterior tibialis EMG responsivity in patients with RLS. The study will include 8 visits over a period of up to 8 weeks for eligible subjects including a 1 to 3-week Screening/Washout Period, a 1-week placebo run-in period, and a 4-week Treatment Period.The first placebo dose will be administered within 1 to 3 weeks after Screening/Washout. The total duration of the study from the first subject enrolled to the last subject completed will be approximately 1 year.

Timeline

Start

2015-06

Primary completion

2016-06

Completion

2016-07

Publications

• Results Winkelman JW, Shahar E, Sharief I, Gottlieb DJ. Association of restless legs syndrome and cardiovascular disease in the Sleep Heart Health Study. Neurology. 2008 Jan 1;70(1):35-42. doi: 10.1212/01.wnl.0000287072.93277.c9.
• Results Alessandria M, Provini F. Periodic Limb Movements during Sleep: A New Sleep-Related Cardiovascular Risk Factor? Front Neurol. 2013 Aug 12;4:116. doi: 10.3389/fneur.2013.00116. eCollection 2013.
• Results Walters AS, Rye DB. Review of the relationship of restless legs syndrome and periodic limb movements in sleep to hypertension, heart disease, and stroke. Sleep. 2009 May;32(5):589-97. doi: 10.1093/sleep/32.5.589.
• Results Sforza E, Jouny C, Ibanez V. Time course of arousal response during periodic leg movements in patients with periodic leg movements and restless legs syndrome. Clin Neurophysiol. 2003 Jun;114(6):1116-24. doi: 10.1016/s1388-2457(03)00077-4.
• Results Earley CJ, Silber MH. Restless legs syndrome: understanding its consequences and the need for better treatment. Sleep Med. 2010 Oct;11(9):807-15. doi: 10.1016/j.sleep.2010.07.007.

Drugs

Indications