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 - ?Estudio de 12 semanas, aleatorizado, doble-ciego controlado con placebo, de grupos paralelos con dosis fijas para evaluar la eficacia y la seguridad de Armodafinil (50, 150 y 250 mg/día) en el tratamiento de pacientes con somnolencia excesiva asociada a un trauma cráneo-cerebral no penetrante leve o moderado - C10953/3067/ES/MN

INTERVENTION: Product Name: Armodafinil Product Code: CEP‐10953 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Armodafinil CAS Number: 112111‐43‐0 Current Sponsor code: CEP‐10953 Other descriptive name: R‐modafinil Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Patients with excessive Sleepiness associated with mild or moderate closed Traumatic Brain Injury (TBI) ; MedDRA version: 12.0 Level: LLT Classification code 10060690 Term: Traumatic brain injury ; MedDRA version: 12.0 Level: LLT Classification code 10015595 Term: Excessive daytime sleepiness PRIMARY OUTCOME: Main Objective: 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). Primary end point(s): The primary efficacy measures and endpoints for this study are the MSLT and CGI‐C assessed at week 12 (or last postbaseline observation). Secondary Objective: ? to evaluate health‐related quality of life in patients assessed by the TBI‐WIS at w 4, 8, 12 (or last postbaseline observation); ? to evaluate the effect of armodafinil treatment on excessive sleepiness:; mean sleep latency from the MSLT assessed at w 4, 8, 12 (average of 4 naps at 0900, 1100, 1300, and 1500), CGI‐C at w 2, 4, 8, 12, ESS scores at w 12 (or last postbaseline observation); ? to evaluate the overall safety and tolerability of armodafinil during 12 weeks of double‐blind treatment:; AEs, clinical laboratory tests at w 4, 8, 12 (or last postbaseline observation), vital signs at w 2, 4, 8, 12 (or last postbaseline observation), physical examinations, incll skin examinations and body weight, at w 12 (or last postbaseline observation), ECG at w 12 (or last postbaseline observation), concomitant medication ; ? to evaluate the effect of armodafinil treatment on nighttime sleep as assessed by NPSG at w 2, 4, 12 (or last postbaseline observation) INCLUSION CRITERIA: ‐ mild (Glasgow Coma Scale [GCS] score 13‐15) or moderate (GCS 9‐12) closed TBI at the time of injury, and injury occurred 1 to 10 years prior to screening. TBI is defined as traumatically induced physiologic disruption of brain function as manifested by 1 of the following: any period of LOC, any loss of memory for events immediately before or after the accident, any alteration of mental state, focal neurological deficits (may or may not be transient) ‐ the patient has a Glasgow Outcome Scale score of 5 at the screening visit ‐ the patient has an ESS score of at least 10 at screening ‐ the patient has a mean sleep latency on the MSLT (average of 4 naps) of less than 8 minutes at baseline ‐ the patient has a Clinical Global Impression of Severity of Illness (CGI‐S) rating relating to their excessive sleepiness of 4 or more at the screening and baseline visits ‐ the patient has a complaint of excessive sleepiness (at least 5 days/week on average)