Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
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 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|
- A comparison between dosing groups on performance on neurocognitive measures [ Time Frame: Within a 7-hour window post dose. ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Almorexant 100mg
Subjects will receive a one-time dose of Almorexant 100mg.
Other Name: Almorexant
Experimental: Almorexant 200mg
Subjects will receive a one-time dose of Almorexant 200mg.
Other Name: Almorexant
Active Comparator: Zolpidem
Subjects will receive a one-time dose of Zolpidem 10mg.
Drug: Zolpidem 10mg
Other Name: Ambien
Placebo Comparator: Placebo
Subjects will receive a one-time dose of Placebo.
One-time dose of Placebo
Other Name: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243060
|Contact: Terri Motraghi, MScfirstname.lastname@example.org|
|Contact: Jennifer Hlavin, M.A.||415-221-4810 ext email@example.com|
|United States, California|
|San Francisco Veterans Affairs Medical Center||Recruiting|
|San Francisco, California, United States, 94121|
|Principal Investigator: Thomas Neylan, M.D.|
|Principal Investigator:||Thomas Neylan, M.D.||Northern California Institute of Research and Education|