CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Armodafinil +1 moredrug
Likely dose
Armodafinil 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00711516
NCT00711516Phase 4Completed
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Double-Blind, Placebo-Controlled, Functional Neuroimaging Study of Armodafinil (200 mg/Day) on Prefrontal Cortical Activation in Patients With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea

Cephalon·interventional·Posted Jul 9, 2008·Updated Jul 19, 2013

In Brief

A Phase 4 clinical trial evaluating Armodafinil and Placebo for Excessive Sleepiness. Completed, enrolled 40 participants across 9 sites.

Detailed Summary

The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have residual sleepiness despite receiving nCPAP therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExcessive Sleepiness
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 9, 2008
Enrollment StartSep 1, 2008
Primary CompletionSep 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.0 years ago

Interventions

Armodafinildrug

Armodafinil once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14.

Placebodrug

Matching Placebo dosed once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14.