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

Oct 18, 2014Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine

Armodafinil for treating excessive sleepiness after mild to moderate closed head injury: 12-week controlled trial with 12-month follow-up

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Abstract

Patients receiving 250 mg armodafinil showed a significant improvement in sleep latency from baseline to final visit, increasing by 7.2 minutes compared to 2.4 minutes for placebo.

Approximately 50% of patients taking 150 mg and 250 mg armodafinil reported much or very much improvement in their condition, compared to 38% on placebo.
No significant differences were observed in Epworth Sleepiness Scale and TBI-Work Instability Scale scores between armodafinil and placebo groups.
In an open-label extension, gradual improvements in sleepiness and work instability were noted up to 48 weeks post-baseline.
Armodafinil was generally well tolerated, with headache being the most common side effect reported.

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OBJECTIVE: To evaluate the efficacy and tolerability of armodafinil in patients with excessive sleepiness following mild or moderate closed traumatic brain injury (TBI).

DESIGN: Randomized, placebo-controlled, double-blind trial followed by open-label extension.

SETTING: 40 US centers.

PATIENTS: Adults with closed TBI (N = 117), Glasgow Coma Scale score >8 at time of injury; baseline Epworth Sleepiness Scale (ESS) ≥10; sleep latency <8 minutes on multiple sleep latency test (MSLT); and Clinical Global Impression-Severity of Illness (CGI-S) score ≥4 for excessive sleepiness.

INTERVENTION: Patients received armodafinil (50, 150, or 250 mg/day) or placebo for 12 weeks followed by an optional 12-month open-label extension.

MEASUREMENTS AND RESULTS: Outcomes included MSLT, ESS, Clinical Global Impression-Change (CGI-C), TBI-Work Instability Scale (TBI-WIS), CGI-S, and tolerability. The study was terminated early due to low enrollment. 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). CGI-C ratings were much/ very much improved in approximately 50% of patients receiving 150 and 250 mg armodafinil, compared to 38% on placebo. ESS and TBI-WIS scores were not significantly different between groups. In the open-label extension (N = 49), patients demonstrated gradual improvement in ESS, TBI-WIS, and CGI-S scores up to 48 weeks post-baseline. Armodafinil was generally well tolerated, with headache the most common adverse event in both double-blind and open-label portions.

CONCLUSIONS: Armodafinil 250 mg significantly improved sleep latency in patients with excessive sleepiness associated with mild or moderate TBI. Efficacy and tolerability of armodafinil were sustained throughout the open-label extension.

TRIAL REGISTRATION: NCT00893789, NCT00983437.

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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

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