drugset / Trial / NCT01243060

Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

NCT01243060

RandomizedParallel-groupQuadruple-blind

Summary

In recent years, there has been increased focus on cognitive side effects of sleep-inducing medications that may contribute to unusual behavior during unexpected awakenings during the night. Concerns regarding these side effects have led to a class Food and Drug Administration (FDA) warning for all sleep-inducing medications. Almorexant is an experimental sleep-inducing medication in a new class of medications that is being extensively developed by multiple pharmaceutical companies. Medications in this class block wake/arousal centers in the brain that function with proteins called hypocretins. The goal of this study is to evaluate the impact on cognitive performance of almorexant vs. zolpidem (an approved sleep aid) or placebo.

Timeline

Start
2011-05
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Zolpidem Small molecule 10 mg
Subject almorexant Small molecule 100 mg
Subject almorexant Small molecule 200 mg

Indications

No indication recorded.