Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

Healthy Volunteers Clinical Trial

Official title:

Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243060
• Other study ID #: NEY-1413
• Status: Completed
• Phase: N/A
• First received: November 17, 2010
• Last updated: October 2, 2014
• Start date: May 2011
• Est. completion date: July 2014

Study information

• Verified date: October 2014
• Source: Northern California Institute of Research and Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 39 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Almorexant
100mg
• Almorexant
200mg
• Zolpidem 10mg
10mg
• Placebo
One-time dose of Placebo

Locations

Country	Name	City	State
United States	San Francisco Veterans Affairs Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Northern California Institute of Research and Education	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A comparison between dosing groups on performance on neurocognitive measures		Within a 7-hour window post dose.	No