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Extension Study of the Safety and Efficacy of CEP-10953 in the Treatment of Patients With Excessive Sleepiness
This study has been completed.
Sponsored by: Cephalon
Information provided by: Cephalon
ClinicalTrials.gov Identifier: NCT00228553
  Purpose

A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of CEP-10953 in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder


Condition Intervention Phase
Excessive Daytime Sleepiness
Narcolepsy
Drug: CEP-10953
Phase III

MedlinePlus related topics: Sleep Apnea Sleep Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title: A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of CEP-10953 in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

Further study details as provided by Cephalon:

Study Start Date: May 2004
Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients are included in the study if all of the following criteria are met:

  • Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) at the beginning of the respective double-blind study, are eligible.
  • The patient has completed a cephalon-sponsored double-blind study (study C10953/3020/NA/MN, C10953/3021/AP/MN, C10953/3022/CM/MN, or C10953/3025/AP/MN), and the investigator has recommended they be enrolled.
  • Patients with OSAHS must continue to be regular users of nCPAP therapy, which the investigator considers to remain effective. Patients with chronic SWSD must work 5 nights/month, with night shifts including at least 6 hours between 2200 and 0800 that are no longer than 12 hours in duration.
  • The patient is considered to be in good health.
  • Women must be surgically sterile, 2 years postmenopausal, or if of childbearing potential, must use a medically accepted method of birth control (ie, barried method with spermacide, steroidal contraceptive [oral, implanted, and Depo-Provera contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]).
  • The patient must be willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.

Exclusion Criteria:

Patients are excluded from participating in this study if 1 or more of the following criteria are met:

  • Have any clinically significant, uncontrolled medical conditions (treated or untreated).
  • Have a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or chronic SWSD.
  • Consume caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine.
  • Use any prescription drugs disallowed by the protocol (as identifed in section 5.2) or clinically significant use of over-the-counter (OTC) drugs within 7 days before visit 1.
  • Have a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM-IV) (American Psychiatric Association 1994).
  • Have a positive urine drug screen (UDS) (subjects enrolling in this open-label study within 7 days after completing the double-blind study may be enrolled without UDS results).
  • Have a clinically significant deviation from normal in the physical examination.
  • Are pregnant or lactating. Any woman becoming pregnant during the study will be withdrawn from the study.
  • Have any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
  • Have a known clinically significant drug sensitivity to stimulants.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00228553

  Show 101 Study Locations
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Gwendolyn Niebler, DO Cephalon
  More Information

Study ID Numbers: C10953/3024/ES/MN
Study First Received: September 27, 2005
Last Updated: November 9, 2007
ClinicalTrials.gov Identifier: NCT00228553  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Sleep Apnea Syndromes
Sleep Disorders, Circadian Rhythm
Apnea
Sleep Apnea, Obstructive
Sleep Disorders
Dyssomnias
Disorders of Environmental Origin
Chronobiology Disorders
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Narcolepsy
Mental Disorders
Occupational Diseases
Gelineau's syndrome

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009