OBJECTIVE: This study examined the effects of @entity1153 on polysomnographic (PSG) measures of sleep and subjective complaints in @entity1 with @entity239 and disturbed sleep. METHODS: This was a single-site, double-blind, placebo-controlled, two-period crossover PSG study. Eligible subjects (aged 28-72 y) were randomized (1:1) to @entity1153 (100 mg/d) or placebo for crossover period 1, and vice versa for @entity5394 . Each crossover period comprised a dose-escalation and dose-maintenance phase, with a 2-w taper/washout between periods. In-laboratory PSGs were collected at baseline, and at the end of each treatment period. The primary endpoints were the difference in PSG-recorded @entity25 ( @entity25 ), number of awakenings after sleep onset (NAASO), and @entity25 ( @entity25 ) between 4 w of maintenance treatment with @entity1153 and placebo. Other PSG measures, subject-rated sleep, fatigue, physical functioning, and @entity158 were assessed. Post hoc analysis was performed in subjects showing at least 25% reduction in @entity158 from baseline in the Brief Pain Inventory Score (responders). RESULTS: Of 19 subjects randomized, 15 completed both periods. Subjects treated with @entity1153 showed no significant improvements in @entity25 and NAASO, but showed reduced @entity25 (p = 0.049). @entity1153 did not show significant improvement in other PSG parameters or subjective endpoints. Two thirds of completers met responder criteria and additionally showed a significant improvement in daily effect of @entity158 (p= 0.043) and subjective @entity25 (p = 0.040). CONCLUSION: The data suggest that @entity1153 is not sedating in most @entity1 with @entity239 and improvements in sleep are likely a result of @entity158 improvement. PROTOCOL TITLE: SAV-MD-17. CLINICALTRIALS.GOV IDENTIFIER: NCT01234675.

The Effects of XXXX on Sleep Disturbance in @entity239 : A Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity5394 :: ('8864', 'Gene') :: ['period 2'] @entity239 :: ('MESH:D005356', 'Disease') :: ['fibromyalgia'] @entity1153 :: ('MESH:C048107', 'Chemical') :: ['milnacipran', 'Milnacipran'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity25 :: ('MESH:D012893', 'Disease') :: ['sleep efficiency', 'WASO', 'wake after sleep onset', 'SE', 'sleep quality']
@entity1153 :: (MESH:C048107,Chemical) :: ['Milnacipran']
