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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Narcolepsy

Intervention: Armodafinil (Drug); Armodafinil (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Cephalon

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)

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks

Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: March 2004
Last updated: July 12, 2013

Page last updated: August 23, 2015

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