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Safety and Efficacy Study of CEP-10953 in the Treatment of Excessive Sleepiness Associated With Narcolepsy
This study has been completed.
First Received: February 24, 2004   Last Updated: January 12, 2006   History of Changes
Sponsored by: Cephalon
Information provided by: Cephalon
ClinicalTrials.gov Identifier: NCT00078377
  Purpose

The primary objective of this study is to determine whether treatment with 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 (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 postbasline visit)


Condition Intervention Phase
Narcolepsy
Drug: CEP-10953
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 Daytime Sleepiness Associated With Narcolepsy

Further study details as provided by Cephalon:

Estimated Enrollment: 300
Study Start Date: December 2003
Estimated Study Completion Date: January 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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 and hematology.
  • 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:

  • has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated)
  • has a probable diagnosis of a current sleep disorder other than narcolepsy
  • consume 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
  • 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

No publications provided

Study ID Numbers: C10953/3020/NA/MN
Study First Received: February 24, 2004
Last Updated: January 12, 2006
ClinicalTrials.gov Identifier: NCT00078377     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Cephalon:
Narcolepsy
Excessive Sleepiness
Cataplexy
Sleep Attacks
Excessive Sleepiness associated with Narcolepsy
Cephalon
Cephalon, Inc
Nuvigil

Study placed in the following topic categories:
Cataplexy
Mental Disorders
Narcolepsy
Gelineau's Syndrome
Dyssomnias
Sleep Disorders
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Mental Disorders
Narcolepsy
Nervous System Diseases
Sleep Disorders
Dyssomnias
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on July 02, 2009