NCT00608985

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

Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group Polysomnography Study to Assess the Efficacy and Safety of a 16-day Oral Administration of ACT-078573 in Adult Subjects With Chronic Primary Insomnia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 709 (actual)
• Sponsor: Midnight Pharma, LLC · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DRUG	almorexant	2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem
DRUG	almorexant	1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem
DRUG	Placebo	2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem
DRUG	zolpidem	2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-09-01
• Completion: 2009-11-01
• First posted: 2008-02-06
• Last updated: 2016-03-14
• Results posted: 2013-02-07

Locations

91 sites across 20 countries: Australia, Austria, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Poland, Slovakia, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom