Conditions: Traumatic Brain Injury
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 117
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Armodafinil 50 mg/day arm 2: Armodafinil 150 mg/day arm 3: Armodafinil 250 mg/day arm 4: Placebo

Interventions: intervention 1: Armodafinil intervention 2: Armodafinil intervention 3: Armodafinil intervention 4: Placebo
Intervention descriptions: intervention 1: Armodafinil 50 mg/day intervention 2: Armodafinil 150 mg/day intervention 3: Armodafinil 250 mg/day intervention 4: Placebo

Protocol document: