Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 19 - 39 |
| Updated: | 11/8/2014 |
| Start Date: | May 2011 |
| End Date: | September 2014 |
| Contact: | Terri Motraghi, MSc |
| Email: | rise.study@ncire.org |
| Phone: | 415-689-0921 |
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.
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.
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.
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.
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
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