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NCT01243060 · ClinicalTrials.gov registry record · NA
Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
A NA study of Healthy Volunteers, sponsored by Northern California Institute of Research and Education.
- Completed
- Registry status
- NA
- Development phase
- 203
- Enrollment target
- 1
- Study location
NCT01243060: Completed NA study of Healthy Volunteers, sponsored by Northern California Institute of Research and Education.
NCT01243060 is a NA study of Healthy Volunteers that has completed, run by Northern California Institute of Research and Education. The registered enrollment target is 203 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01243060, a NA study of Healthy Volunteers, has completed, sponsored by Northern California Institute of Research and Education.
- COMPLETED
- Registry status
- NA
- Development phase
- 203 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Almorexant
- DRUG Zolpidem 10mg
Study Locations (1)
California
- San Francisco Veterans Affairs Medical Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-07 |
| Phase | NA |
What the finished NCT01243060 record still lists
NCT01243060 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01243060 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01243060 about?
NCT01243060 is a clinical study titled "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 ...
What is the current status of trial NCT01243060?
This trial is currently completed. It is a NA study. The enrollment target is 203 participants. The study started on 2011-05. Estimated completion is 2014-07.
What conditions does trial NCT01243060 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT01243060?
The interventions under investigation include: Placebo (DRUG), Almorexant (DRUG), Zolpidem 10mg (DRUG).
Who is sponsoring clinical trial NCT01243060?
This trial is sponsored by Northern California Institute of Research and Education, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01243060 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01243060's enrollment target sits among peer trials
203 45th of 283 higher than 237 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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