Status:
COMPLETED
Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy
Lead Sponsor:
Cephalon
Conditions:
Narcolepsy
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 narco...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT00078377
Start Date
March 1 2004
End Date
January 1 2005
Last Update
July 19 2013
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