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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 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.

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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

FieldValue
Enrollment Target 203 participants
Start Date 2011-05
Est. Completion 2014-07
Phase NA

What the Registry Record Tells You About NCT01243060

The ClinicalTrials.gov registry entry for NCT01243060 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 203 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (58% lower). The listed sponsor is Northern California Institute of Research and Education, which has 6 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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