CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 247 enrolled
Drug / intervention
Armodafinildrug
Likely dose
Armodafinil 150-250 mg/dayAI-extracted
Key inclusion· 6
  • ✓Age 18-65 years, English-speaking
  • ✓Excessive sleepiness due to narcolepsy or OSAHS (diagnosed per ICSD criteria)
  • ✓For OSAHS: regular nCPAP user (≥4 hours/night on ≥70% of nights) with stable therapy for ≥4 weeks
  • ✓Dissatisfied with current sleepiness therapy (pharmacologic, nap, or bright light) due to efficacy and/or safety
Key exclusion· 10
  • ✕Uncontrolled clinically significant medical or psychiatric conditions
  • ✕Other primary sleep disorder besides narcolepsy or OSAHS
  • ✕Caffeine consumption >600 mg/day within 1 week of study start
  • ✕Medically unexplainable positive urine drug screen

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00228566
NCT00228566Phase 3Completed
CompareCT.gov

A Short-term (8 Week) Open-Label Study, Followed by a Long Term Evaluation, to Assess Patient-Reported Outcomes With Armodafinil Treatment (150 to 250 mg/Day) for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

Cephalon·interventional·Posted Sep 29, 2005·Updated Jul 19, 2013

In Brief

A Phase 3 clinical trial evaluating Armodafinil for Excessive Daytime Sleepiness and 2 related conditions. Completed, enrolled 247 participants across 43 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExcessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 29, 2005
Enrollment StartOct 1, 2005
Study CompletionJul 1, 2006
TodayJul 2, 2026
Posted 20.8 years ago

Interventions

Armodafinildrug