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NCT00228566 · ClinicalTrials.gov registry record · Phase 3

Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

A Phase 3 study of Narcolepsy and Excessive Daytime Sleepiness, sponsored by Cephalon.

Completed
Registry status
Phase 3
Development phase
247
Enrollment target
20
Study locations

NCT00228566 is a Phase 3 study of Narcolepsy and Excessive Daytime Sleepiness that has completed, run by Cephalon. The registered enrollment target is 247 participants, below the 360-participant average among 12 other Narcolepsy trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT00228566, a Phase 3 study of Narcolepsy and Excessive Daytime Sleepiness, has completed, sponsored by Cephalon.

COMPLETED
Registry status
Phase 3
Development phase
247 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also be assessed.

Conditions Studied

Narcolepsy Excessive Daytime Sleepiness Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)

Interventions

  • DRUG Armodafinil

Study Locations (20)

California

  • Advanced Clinical Research Institute - Anaheim
  • West Coast Clinical Trials, Inc - Long Beach
  • Neuro-Therapeutics, Inc - Pasadena
  • Penninsula Research Associates - Rolling Hills Estates
  • Pacific Sleep Program - San Francisco
  • The Sleep Disorders Center of Santa Barbara - Santa Barbara

Arizona

  • Pulmonary Associates - Phoenix
  • HOPE Research Institute - Phoenix
  • PsyPharm Clinical Research - Phoenix
  • PsyPharm Clinical Research Inc. - Tucson

Georgia

  • Child Neurology Associates, PC - Atlanta
  • Neurotrials, Inc. - Atlanta
  • Sleepmed Inc. - Macon
  • Savannah Neuurology - Savannah

Alabama

  • Sleep Disorders Center of Alabama - Birmingham
  • Neurology Consultants of Tuscaloosa, P.C. - Tuscaloosa

Arkansas

  • Neurology and Clinical Study Center - Little Rock

Colorado

  • Colorado Sleep Disorder Center - Englewood

Florida

  • Clinical Research Group of St. Petersburg - St. Petersburg

Illinois

  • Evanston Northwestern Healthcare, Evanston Hospital - Evanston

Trial Details

FieldValue
Enrollment Target 247 participants
Start Date 2005-10
Est. Completion 2006-07
Phase Phase 3

Sponsor

Cephalon

64 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00228566

The ClinicalTrials.gov registry entry for NCT00228566 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 360-participant average among 12 other Narcolepsy trials with a reported enrollment target (31% lower). The listed sponsor is Cephalon, which has 64 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Narcolepsy appearing as the primary indexed condition, and to 1 intervention - of which Armodafinil is the first listed.

NCT00228566 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Arizona, Georgia.

Frequently Asked Questions

What is clinical trial NCT00228566 about?

NCT00228566 is a clinical study titled "Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome". The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Clinician ra...

What is the current status of trial NCT00228566?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 247 participants. The study started on 2005-10. Estimated completion is 2006-07.

What conditions does trial NCT00228566 study?

This clinical trial studies the following conditions: Narcolepsy, Excessive Daytime Sleepiness, Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS).

What interventions are being tested in trial NCT00228566?

The interventions under investigation include: Armodafinil (DRUG).

Who is sponsoring clinical trial NCT00228566?

This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00228566 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.