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Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Thomas C. Neylan, M.D., Northern California Institute of Research and Education
ClinicalTrials.gov Identifier:
NCT01243060
First received: November 17, 2010
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Healthy Volunteers
Drug: Almorexant
Drug: Zolpidem 10mg
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

Resource links provided by NLM:


Further study details as provided by Northern California Institute of Research and Education:

Primary Outcome Measures:
  • A comparison between dosing groups on performance on neurocognitive measures [ Time Frame: Within a 7-hour window post dose. ] [ Designated as safety issue: No ]

Enrollment: 203
Study Start Date: May 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Almorexant 100mg
Subjects will receive a one-time dose of Almorexant 100mg.
Drug: Almorexant
100mg
Other Name: Almorexant
Experimental: Almorexant 200mg
Subjects will receive a one-time dose of Almorexant 200mg.
Drug: Almorexant
200mg
Other Name: Almorexant
Active Comparator: Zolpidem
Subjects will receive a one-time dose of Zolpidem 10mg.
Drug: Zolpidem 10mg
10mg
Other Name: Ambien
Placebo Comparator: Placebo
Subjects will receive a one-time dose of Placebo.
Drug: Placebo
One-time dose of Placebo
Other Name: 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.

  Eligibility

Ages Eligible for Study:   19 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243060

Locations
United States, California
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
Northern California Institute of Research and Education
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Thomas Neylan, M.D. Northern California Institute of Research and Education
  More Information

No publications provided

Responsible Party: Thomas C. Neylan, M.D., Principal Investigator, Northern California Institute of Research and Education
ClinicalTrials.gov Identifier: NCT01243060     History of Changes
Other Study ID Numbers: NEY-1413
Study First Received: November 17, 2010
Last Updated: October 2, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board

Keywords provided by Northern California Institute of Research and Education:
Sleep Aid

Additional relevant MeSH terms:
Zolpidem
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Agonists
GABA-A Receptor Agonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014