drugset / Trial / NCT00640848

Almorexant in Primary Insomnia

NCT00640848 ↗

Phase 1 Completed 161 enrolled Midnight Pharma, LLC
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2006-05
Primary completion
2007-08
Completion
2007-09

Outcome

Met primary endpoint

paper SE improved significantly after almorexant 400 mg vs. placebo (mean treatment effect 14.4%; P < 0.001). PMID 22549286 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject almorexant Small molecule 50 mg —
Subject almorexant Small molecule 100 mg —
Subject almorexant Small molecule 200 mg —
Subject almorexant Small molecule 400 mg —
Subject almorexant Small molecule 1000 mg —

Indications