NCT00640848

Almorexant in Primary Insomnia

Multi-center, Multiple-stage, Double-blind, Randomized, Placebo-controlled, Two-way Crossover, Single-dose Study to Investigate the Effects of ACT-078573 on Sleep Measured by Polysomnography in Patients With Primary Insomnia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Midnight Pharma, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to determine the minimum effective dose of ACT-078573 on sleep efficiency and to assess the effects of different doses of ACT-078573 on other PSG parameters.

Conditions

• Insomnia
• Primary Insomnia

Interventions

Type	Name	Description
DRUG	almorexant	1 dose of 400 mg in two treatment sequences
DRUG	almorexant	1 dose of 200 mg in two treatment sequences
DRUG	almorexant	1 dose of 100 mg in two treatment sequences
DRUG	almorexant	1 dose of 50 mg mg in two treatment sequences
DRUG	almorexant	1 dose of 1000 mg in two treatment sequences

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-08-01
• Completion: 2007-09-01
• First posted: 2008-03-21
• Last updated: 2016-02-12

Locations

27 sites across 10 countries: Austria, Denmark, Finland, Germany, Israel, Netherlands, Spain, Sweden, Switzerland, United Kingdom