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Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE November 17, 2010
First Posted Date  ICMJE November 18, 2010
Last Update Posted Date October 6, 2014
Study Start Date  ICMJE May 2011
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2010)
A comparison between dosing groups on performance on neurocognitive measures [ Time Frame: Within a 7-hour window post dose. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01243060 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
Official Title  ICMJE Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Almorexant
    100mg
  • Drug: Almorexant
    200mg
  • Drug: Zolpidem 10mg
    10mg
    Other Name: Ambien
  • Drug: Placebo
    One-time dose of Placebo
Study Arms  ICMJE
  • Experimental: Almorexant 100mg
    Subjects will receive a one-time dose of Almorexant 100mg.
    Intervention: Drug: Almorexant
  • Experimental: Almorexant 200mg
    Subjects will receive a one-time dose of Almorexant 200mg.
    Intervention: Drug: Almorexant
  • Active Comparator: Zolpidem
    Subjects will receive a one-time dose of Zolpidem 10mg.
    Intervention: Drug: Zolpidem 10mg
  • Placebo Comparator: Placebo
    Subjects will receive a one-time dose of Placebo.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2014)
203
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2010)
216
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01243060
Other Study ID Numbers  ICMJE NEY-1413
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas C. Neylan, M.D., Northern California Institute of Research and Education
Study Sponsor  ICMJE Northern California Institute of Research and Education
Collaborators  ICMJE U.S. Army Medical Research and Materiel Command
Investigators  ICMJE
Principal Investigator: Thomas Neylan, M.D. Northern California Institute of Research and Education
PRS Account Northern California Institute of Research and Education
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP