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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: Completed Phase 3 study of Narcolepsy and Excessive Daytime Sleepiness, sponsored by Cephalon.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A subjective measure (PGI-C rating) of the patient's global health, ie, a patient's rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2005-10 |
| Est. Completion | 2006-07 |
| Phase | Phase 3 |
What the finished NCT00228566 record still lists
NCT00228566 is an interventional study that assigns participants to a tested intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap, below the 360-participant average among 12 other Narcolepsy trials with a reported enrollment target (31% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
Similar trials for Narcolepsy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00228566's enrollment target sits among peer trials
247 4th of 12 higher than 9 of 12 other Narcolepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Narcolepsy 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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