extension study of the safety and efficacy of armodafinil in the treatment of patients with excessive sleepiness

Conditions: Excessive Daytime Sleepiness; Narcolepsy; Obstructive Sleep Apnea/Hypopnea Syndrome; Chronic Shift Work Sleep Disorder

Summary: a 12 month, open-label, flexible dosage extension study of the safety and efficacy of armodafinil (cep-10953) in the treatment of patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, or chronic shift work sleep disorder


Eligibility criteria:
inclusion criteria: patients are included in the study if all of the following criteria are met: * men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) at the beginning of the respective double-blind study, are eligible. * the patient has completed a cephalon-sponsored double-blind study (study c10953/3020/na/mn, c10953/3021/ap/mn, c10953/3022/cm/mn, or c10953/3025/ap/mn), and the investigator has recommended they be enrolled. * patients with osahs must continue to be regular users of ncpap therapy, which the investigator considers to remain effective. patients with chronic swsd must work 5 nights/month, with night shifts including at least 6 hours between 2200 and 0800 that are no longer than 12 hours in duration. * the patient is considered to be in good health. * women must be surgically sterile, 2 years postmenopausal, or if of childbearing potential, must use a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive \[oral, implanted, and depo-provera contraceptives must be used in conjunction with a barrier method\], or intrauterine device \[iud\]). * the patient must be willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol. exclusion criteria: patients are excluded from participating in this study if 1 or more of the following criteria are met: * have any clinically significant, uncontrolled medical conditions (treated or untreated). * have a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, osahs, or chronic swsd. * consume caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine. * use any prescription drugs disallowed by the protocol or clinically significant use of over-the-counter (otc) drugs within 7 days before visit 1. * have a history of alcohol, narcotic, or any other drug abuse as defined by the diagnostic and statistical manual of the american psychiatric association, 4th edition (dsm-iv) (american psychiatric association 1994). * have a positive urine drug screen (uds) (subjects enrolling in this open-label study within 7 days after completing the double-blind study may be enrolled without uds results). * have a clinically significant deviation from normal in the physical examination. * are pregnant or lactating. any woman becoming pregnant during the study will be withdrawn from the study. * have any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery). * have a known clinically significant drug sensitivity to stimulants.