Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia

Phase 3 Completed 709 enrolled Midnight Pharma, LLC

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

Timeline

Start: 2008-03
Primary completion: 2009-09
Completion: 2009-11

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Almorexant 200mg; p <0.0001; Median Difference (Net) -26.8 (95% CI -34.3 to -19.5); Wilcoxon rank-sum NCT00608985 ↗

registry analysis (superiority or other test); Placebo vs Almorexant 200mg; p <0.0001; Median Difference (Net) -19.5 (95% CI -27.3 to -12.3); Wilcoxon rank-sum NCT00608985 ↗

registry analysis (superiority or other test); Placebo vs Almorexant 200mg; p = 0.0006; Median Difference (Net) -10.4 (95% CI -16.4 to -4.6); Wilcoxon rank-sum NCT00608985 ↗

Publications

Black J, Pillar G, Hedner J, Polo O, Berkani O, Mangialaio S, Hmissi A, Zammit G, Hajak G. Efficacy and safety of almorexant in adult chronic insomnia: a randomized placebo-controlled trial with an active reference. Sleep Med. 2017 Aug;36:86-94. doi: 10.1016/j.sleep.2017.05.009. Epub 2017 May 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Zolpidem	Small molecule	10 mg	—
Subject	almorexant	Small molecule	100 mg	Oral
Subject	almorexant	Small molecule	200 mg	Oral