Completed

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

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What is being tested

Armodafinil

+ Placebo

Drug
Who is being recruted

Sleepiness+5

+ Mental Disorders

+ Disorders of Excessive Somnolence

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorCephalon
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2004

Actual date on which the first participant was enrolled.

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)

Official TitleA 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 
NCT00078377
Principal SponsorCephalon
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

196 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SleepinessMental DisordersDisorders of Excessive SomnolenceNarcolepsyNervous System DiseasesSleep Wake DisordersSleep Disorders, IntrinsicDyssomnias

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Armodafinil 250 mg

Group II

Experimental
Armodafinil 150 mg

Group III

Placebo
Placebo

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
CompletedNo study centers