Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

Inclusion Criteria:

• The patient had a mild (Glasgow Coma Scale [GCS] score = 13-15) or moderate (GCS score = 9-12) closed TBI at the time of the injury, and the injury occurred 1 to 10 years prior to screening.
• The patient has a Glasgow Outcome Scale score of 5.
• The patient has an ESS score of at least 10.
• The patient has a mean sleep latency on the MSLT (average of 4 naps) of less than 8 minutes.
• The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating relating to their excessive sleepiness of 4 or more.
• The patient has a complaint of excessive sleepiness (at least 5 days/week on average) for at least 3 months, and the excessive sleepiness began within 12 months of the TBI identified according to the first inclusion criterion.
• The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness.
• The patient is in otherwise good health, as judged by the investigator, on the basis of a medical and psychiatric history, physical examination, ECG, serum chemistry, hematology, and urinalysis.
• The patient had no other head injuries that, based on medical record documentation or history from the patient and reliable informant (if available), were temporally related to the onset or to any worsening of excessive sleepiness.
• The patient had no other head injury fulfilling the criteria for TBI within ±1 year of the TBI identified according to the first inclusion criterion.
• The patient has a habitual bedtime between 2100 and 2400.

Exclusion Criteria:

• The patient has a history of 2 or more episodes of transient loss of consciousness without clear medical explanation, or has a history of known or suspected pseudoseizure (psychogenic seizure). Patients with a history of seizure or epilepsy may be eligible following discussion with the medical monitor.
• The patient requires, or is likely to require, treatment with anticonvulsant medication during the study; or has taken anticonvulsant medication within 6 months before the screening visit.
• The patient has had neurosurgery involving the brain or brainstem.
• The patient has any current Axis I disorder (including depression and posttraumatic stress disorder [PTSD]), as assessed by SCID. Patients with any Axis II disorder, that in the opinion of the investigator, would affect patient participation in the study or full compliance with study procedures.
• The patient has a history of, or currently meets The International Classification of Sleep Disorders, Edition 2 (ICSD-2) criteria for any other sleep disorder associated with excessive daytime sleepiness; or the patient has a history of idiopathic hypersomnia, insomnia (requiring treatment), or sleep disorder before the development of the TBI.
• The patient has a need for chronic pain medications.
• The subject has a history (within the past 5 years) of alcohol, narcotic, or any other drug abuse (with the exception of nicotine) as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM-IV-TR).
• The patient has used any investigational drug within 1 month before the screening visit.