Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Zolpidem 10mg; Drug: Placebo; Drug: Almorexant

• Registration Number: NCT01243060
• Lead Sponsor: Northern California Institute of Research and Education

Brief 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.

Detailed Description

Up to 216 healthy volunteers will be enrolled to participate in the 10 day study. After screening procedures have been completed (at SFVAMC), Days 1 - 7 will take place in subjects' homes, where their sleep/wake activity will be monitored. Days 8 - 10 will take place at Moffitt Hospital. On Day 10, subjects will take one dose of either almorexant 100mg, almorexant 200mg, zolpidem 10mg, or placebo. Cognitive tests will be administered to subjects throughout Day 10. Subjects will return for follow-up safety labs within 5 - 12 days of dosing with study medication. Based on animal studies, it is anticipated that subjects who take almorexant will be less cognitively impaired than those who take zolpidem.

Study Timeline

• Study First Submitted: 2010-11-17
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Study Start: 2011-05
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-02
• Last Update Posted: 2014-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zolpidem	Zolpidem 10mg	Subjects will receive a one-time dose of Zolpidem 10mg.
Placebo	Placebo	Subjects will receive a one-time dose of Placebo.
Almorexant 200mg	Almorexant	Subjects will receive a one-time dose of Almorexant 200mg.
Almorexant 100mg	Almorexant	Subjects will receive a one-time dose of Almorexant 100mg.

Primary Outcome Measures

Name	Time	Method
A comparison between dosing groups on performance on neurocognitive measures	Within a 7-hour window post dose.

Trial Locations

Locations (1)

San Francisco Veterans Affairs Medical Center; 🇺🇸 San Francisco, California, United States