Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated with Narcolepsy

The primary objective of this study is to determine whether treatment with 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 (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 postbasline visit)

Official Title

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CEP-10953 (150 and 250 mg/day) as Treatment for Adults with Excessive Daytime Sleepiness Associated with Narcolepsy

Conditions

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Study Start

Study start: December 2003; Expected completion: September 2004

Eligibility & Criteria

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 and hematology. 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:has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated) has a probable diagnosis of a current sleep disorder other than narcolepsy consume 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 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

Total Enrolment

300

Contact Details

Monash Medical Center, Melbourne, Victoria, 3168, Australia; Recruiting Karen Smith 61-3-95942133 karen_sleep@hotmail.com Michael Ho, MD, Principal Investigator