Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

October 2, 2014 updated by: Thomas C. Neylan, M.D., Northern California Institute of Research and Education
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

203

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

To participate in the study, participants must:

  • Be between the ages of 19 and 39
  • Be in good physical health
  • Be a good sleeper with consistent bedtimes and wake times
  • Not have problems falling or staying asleep
  • Be a non-smoker
  • Meet our other study criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Almorexant 100mg
Subjects will receive a one-time dose of Almorexant 100mg.
Drug: Almorexant
100mg
Drug: Almorexant
200mg
Experimental: Almorexant 200mg
Subjects will receive a one-time dose of Almorexant 200mg.
Drug: Almorexant
100mg
Drug: Almorexant
200mg
Active Comparator: Zolpidem
Subjects will receive a one-time dose of Zolpidem 10mg.
Drug: Zolpidem 10mg
10mg
Other Names:
  • Ambien
Placebo Comparator: Placebo
Subjects will receive a one-time dose of Placebo.
Drug: Placebo
One-time dose of Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A comparison between dosing groups on performance on neurocognitive measures
Time Frame: Within a 7-hour window post dose.
Within a 7-hour window post dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern California Institute of Research and Education

Collaborators

U.S. Army Medical Research and Development Command

Investigators

  • Principal Investigator: Thomas Neylan, M.D., Northern California Institute of Research and Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

November 17, 2010

First Submitted That Met QC Criteria

November 17, 2010

First Posted (Estimate)

November 18, 2010

Study Record Updates

Last Update Posted (Estimate)

October 6, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEY-1413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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