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Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

NCT01243060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2014-10-06

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Almorexant

100mg

DRUG

Almorexant

200mg

DRUG

Zolpidem 10mg

10mg

DRUG

Placebo

One-time dose of Placebo

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Northern California Institute of Research and Education

    lead OTHER

Principal Investigators

  • Thomas Neylan, M.D. · Northern California Institute of Research and Education

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01243060 on ClinicalTrials.gov