Clinical trial NCT00078377: Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy
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 Sleepiness Associated With Narcolepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Narcolepsy
Keywords: Narcolepsy
Excessive Sleepiness
Cataplexy
Sleep Attacks
Excessive Sleepiness associated with Narcolepsy
Cephalon
Cephalon, Inc
Nuvigil
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2004-02-26
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks
timeFrame: change from baseline at 12 weeks
measure: Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks
timeFrame: change from baseline at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: