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Trial record 91 of 119 for:    zolpidem AND Hypnotics

Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

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ClinicalTrials.gov Identifier: NCT01243060
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : October 6, 2014
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

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Almorexant Drug: Zolpidem 10mg Drug: Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
Study Start Date : May 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Almorexant 100mg
Subjects will receive a one-time dose of Almorexant 100mg.
Drug: Almorexant
100mg

Experimental: Almorexant 200mg
Subjects will receive a one-time dose of Almorexant 200mg.
Drug: Almorexant
200mg

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




Primary Outcome Measures :
  1. A comparison between dosing groups on performance on neurocognitive measures [ Time Frame: Within a 7-hour window post dose. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 18, 2010    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: October 2014

Keywords provided by Thomas C. Neylan, M.D., Northern California Institute of Research and Education:
Sleep Aid

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