A 12-week, randomized, double-blind, placebo-controlled, parallel-group. fixed-dosage study to evaluate the efficacy and safety of armodafinil (50, 150, and 250 mg/day) as treatment for patients with ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-014545-83

A 12-week, randomized, double-blind, placebo-controlled, parallel-group. fixed-dosage study to evaluate the efficacy and safety of armodafinil (50, 150, and 250 mg/day) as treatment for patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury

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Extrait

The primary objective of the sudy 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) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20-minute version; average of 4 naps at 0900, 1100, 1300, abd 1500) and proportion of responders (patients who are much or very much improved) according to the Clinical Global Impression of Change (CGI-C) ratings relating to excessive sleepiness at week 12 (or last postbaseline observation).


Critère d'inclusion

  • Patients with excessive Sleepiness associated with mild or moderate closed Traumatic Brain Injury (TBI)