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

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 pseudo seizure (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 an unstable or uncontrolled medical (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition (treated or untreated) or was not a suitable candidate for treatment with armodafinil, as judged by the investigator.
• •The patient has had neurosurgery involving the brain or brainstem.
• •The patient has a history of schizophrenia, bipolar disorder, psychotic depression, or other psychotic episode.
• •The patient has any current Axis I disorder (including depression and posttraumatic stress disorder \[PTSD\]), as assessed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (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 85% or less sleep efficiency (sleep duration ÷ time in bed x 100%) as determined from Nocturnal Polysomnography (NPSG).
• •The patient has any disorder that may have interfered with drug absorption, distribution, metabolism, or excretion.
• •The patient has used any medications including over-the-counter (OTC) medicines disallowed by the protocol within 7 days or 5 half-lives (medication or its active metabolites), whichever is longer.
• •The patient has a need for chronic pain medications.
• •In the judgment of the investigator, the patient has a clinically significant deviation from normal in the physical examination.
• •In the judgment of the investigator, the patient has any clinically significant ECG finding.
• •The patient has a diagnosis of any type of dementia.
• •The patient has a history of suicidal ideation (considered by the investigator to be of clinical significance), or is suicidal.
• •The patient has a known hypersensitivity to armodafinil, racemic modafinil, or any component of the study drug tablets. Armodafinil tablets contained the following inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.
• •The patient has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions.
• •The patient has a clinical laboratory test value(s) outside the range(s) specified in the protocol (or any other clinically significant laboratory abnormality), and the medical monitor had not provided written approval for study participation.
• •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) or the patient had current evidence of substance use, without medical explanation, confirmed by results of a urine drug screen (UDS).
• •The patient has taken armodafinil, modafinil, or other stimulant medication for excessive sleepiness within 1 month of the screening visit.
• •The patient is a pregnant or lactating woman.
• •The patient is known to have tested positive for human immunodeficiency virus (HIV).
• •The patient consumes an average of more than 600 mg of caffeine per day, including coffee, tea and/or other caffeine-containing beverages or food.
• •The patient has used any investigational drug within 1 month before the screening visit.
• •The patient is receiving workmen's compensation or was in active litigation with regard to TBI.
• •The patient has a Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) score of more than 4.
• •The patient has any clinically significant unstable or uncontrolled medical, surgical, or psychiatric conditions (treated or untreated) or may not be a suitable candidate for treatment with armodafinil, as judged by the investigator or medical monitor.
• •The patient has current evidence of active psychosis, including stimulant-induced psychosis or mania.
• •The patient has current evidence of non-medical substance use confirmed by results of a UDS.
• •The patient has used any medications including OTC medicines disallowed by the protocol (except armodafinil use in study 3067) within 7 days or 5 half-lives of the drug and its active metabolites, whichever is longer.
• •The patient has a clinically significant deviation from normal in the physical examination as judged by the investigator.
• •The patient has a clinically significant laboratory abnormality, as judged by the investigator, without prior written approval by the medical monitor.
• •The patient has hypersensitivity to armodafinil or modafinil, or any of the excipients of either.
• •The patient is a pregnant or lactating woman.
• •The patient is unlikely to comply with the study protocol, or is unsuitable for any other reason, as judged by the investigator.
• •The patient consumes an average of more than 600 mg of caffeine per day (approximately equivalent to 5 or more cups of coffee), including coffee, tea, and/or other caffeine-containing beverages or food.