Conditions: Traumatic Brain Injury
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 49
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).

Detailed description:

Arms:
arm 1: Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.

Interventions: intervention 1: Armodafinil
Intervention descriptions: intervention 1: None

Protocol document: