safety and efficacy study of armodafinil (cep-10953) in the treatment of excessive sleepiness associated with narcolepsy

Conditions: Narcolepsy

Summary: the primary objective of this study is to determine whether treatment with armodafinil (cep-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with narcolepsy by measuring mean sleep latency from the maintenance of wakefulness test (mwt) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500) and by the clinical global impressions of change (cgi-c) ratings (as related to general condition) at week 12 (or last postbaseline observation)


Eligibility criteria:
diagnosis and criteria for inclusion: patients are included in the study if all of the following criteria are met: * written informed consent is obtained * the patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive) * the patient has a complaint of excessive sleepiness * the patient has a current diagnosis of narcolepsy according to icsd criteria. * the patient is in good health as determined by a medical and psychiatric history, physical examination, electrocardiogram (ecg), and serum chemistry, hematology, and urinalysis. * women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, using 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 \[iud\]) and agree to continued use of this method for the duration of the study. * the patient has a mean sleep latency of 6 minutes or less as determined by the multiple sleep latency test (mslt) (performed at 0900, 1100, 1300, and 1500). * the patient has a cgi-s (clinical global impression of severity of illness) rating of 4 or more. * the patient does not have any medical or psychiatric disorders that could account for the excessive daytime sleepiness. * the patient is able to complete self rating scales and computer-based testing. * the patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol. criteria for exclusion: patients are excluded from participating in this study if 1 or more of the following criteria are met. the patient: * has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated) * has a probable diagnosis of a current sleep disorder other than narcolepsy * consumed caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day * used any prescription drugs disallowed by the protocol or clinically significant use of over the-counter (otc) drugs within 7 days before the second screening visit * has a history of alcohol, narcotic, or any other drug abuse as defined by the diagnostic and statistical manual of mental disorders of the american psychiatric association, 4th edition (dsm iv) * has a positive uds at the screening visit, without medical explanation * has a clinically significant deviation from normal in the physical examination * is a pregnant or lactating woman. (any woman becoming pregnant during the study will be withdrawn from the study.) * has used an investigational drug within 1 month before the screening visit * has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery) * has a known clinically significant drug sensitivity to stimulants or modafinil

Keywords: narcolepsy excessive sleepiness cataplexy sleep attacks excessive sleepiness associated with narcolepsy cephalon cephalon, inc nuvigil