Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

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

NCT00228566 · View on ClinicalTrials.gov ↗

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.

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

17 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cephalon, which has 17 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00228566 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Arizona, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00228566?

The interventions under investigation include: Armodafinil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00228566?

This trial is sponsored by Cephalon, which has 17 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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