Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

Summary

The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).

Timeline

Start

2009-04-30

Primary completion

2011-01-31

Completion

2011-01-31

Outcome

Mixed primary results

Stopped (Business): “Study has been stopped by sponsor decision.”

paper Patients receiving 250 mg armodafinil showed significant improvement in sleep latency from baseline to final visit versus placebo (+7.2 minutes vs. +2.4 minutes; p = 0.0010). PMID 25325609 ↗

registry analysis (unspecified test); Placebo vs Armodafinil 250 mg/Day; p = 0.0010; ANCOVA; NCT00893789 ↗

registry analysis (unspecified test); Placebo vs Armodafinil 250 mg/Day; p = 0.4401; Pearson's chi-squared NCT00893789 ↗

Publications

• Menn SJ, Yang R, Lankford A. Armodafinil for the treatment of excessive sleepiness associated with mild or moderate closed traumatic brain injury: a 12-week, randomized, double-blind study followed by a 12-month open-label extension. J Clin Sleep Med. 2014 Nov 15;10(11):1181-91. doi: 10.5664/jcsm.4196.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Armodafinil	Small molecule	50 mg	—
Subject	Armodafinil	Small molecule	150 mg	—
Subject	Armodafinil	Small molecule	250 mg	—

Indications