Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy

• ClinicalTrials.gov Identifier: NCT00078377
• Recruitment Status: Completed
• First Posted: February 26, 2004
• Results First Posted: January 21, 2010
• Last Update Posted: July 19, 2013
• Sponsor: Cephalon
• Information provided by: Teva Branded Pharmaceutical Products R&D, Inc.

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Narcolepsy	Drug: Armodafinil; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 196 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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 Start Date: March 2004
• Actual Primary Completion Date: January 2005
• Actual Study Completion Date: January 2005

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Armodafinil 250 mg	Drug: Armodafinil; Armodafinil 250 mg once daily in the morning
Experimental: 2; Armodafinil 150 mg	Drug: Armodafinil; Armodafinil 150 mg once daily in the morning
Placebo Comparator: 3; Placebo	Drug: Placebo; Matching placebo tablets once daily

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks [ Time Frame: change from baseline at 12 weeks ]
   The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).
2. Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks [ Time Frame: change from baseline at 12 weeks ]
   Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• ClinicalTrials.gov Identifier: NCT00078377
• Other Study ID Numbers: C10953/3020/NA/MN
• First Posted: February 26, 2004
• Results First Posted: January 21, 2010
• Last Update Posted: July 19, 2013
• Last Verified: July 2013

Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.:

Narcolepsy; Excessive Sleepiness; Cataplexy; Sleep Attacks; Excessive Sleepiness associated with Narcolepsy; Cephalon; Cephalon, Inc; Nuvigil

Additional relevant MeSH terms:

Narcolepsy; Sleepiness; Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Modafinil; Central Nervous System Stimulants; Physiological Effects of Drugs; Wakefulness-Promoting Agents; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 Enzyme Inducers; Molecular Mechanisms of Pharmacological Action