Effects of Gabapentin Enacarbil on Arousals, Heart Rate, Blood Pressure and PLMs in Restless Legs Syndrome
Status:
Unknown status
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
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.