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CEP-10953 for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
This study has been completed.
First Received: February 23, 2004   Last Updated: September 7, 2007   History of Changes
Sponsor: Cephalon
Information provided by: Cephalon
ClinicalTrials.gov Identifier: NCT00078312
  Purpose

The primary objective of this study is to evaluate the safety and tolerability of CEP-10953 administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder (SWSD). Safety and tolerability will be evaluated throughout the study through adverse event data, clinical laboratory test evaluations, vital sign measurements, electrocardiography, and physical examination findings.


Condition Intervention Phase
Narcolepsy
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Shift-Work Sleep Disorder
Drug: CEP-10953
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: A 12-Month, Open Label, Flexible-Dosage Study of the Safety/Efficacy of CEP 10953 in the Treatment of Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

Resource links provided by NLM:


Further study details as provided by Cephalon:

Estimated Enrollment: 300
Study Start Date: January 2004
Estimated Study Completion Date: June 2005
  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:

  1. Written informed consent is obtained.
  2. Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) are eligible.
  3. The patient has a complaint of excessive sleepiness associated with a current diagnosis of:

    • Narcolepsy-Diagnosis made on the basis of International Classification of Sleep Disorders (ICSD) (American Sleep Disorders Association 2000) criteria.
    • OSAHS-Diagnosis made on the basis of ICSD criteria. Furthermore, patients with OSAHS must meet the following nCPAP therapy requirements:

      • Previous adequate education and intervention efforts to encourage nCPAP therapy use must be documented.
      • A patient's nCPAP therapy regimen must be stable for at least 4 weeks.
      • nCPAP therapy is effective, in the opinion of the investigator.
      • Evidence of regular nCPAP usage must be shown during a 2 week evaluation period (ie, nCPAP therapy usage of at least 4 hours/night on at least 70% of the nights).
    • Chronic SWSD-Diagnosis made on the basis of at least minimum ICSD criteria. Furthermore, patients with chronic SWSD must have had excessive sleepiness during night shifts for at least 3 months, work a minimum of 3 night shifts per month that include at least 6 hours between 2200 and 0800 and are no longer than 12 hours in duration, and plan to continue to work night shifts throughout the study.
  4. The patient has a Clinical Global Impression of Severity of Disease (CGI-S) rating of 4 or more. (For patients with OSAHS, the CGI-S scale will be administered after nCPAP effectiveness and regular usage is established. For patients with narcolepsy or OSAHS, CGI-S will be evaluated to assess general clinical condition. For patients with SWSD, CGI-S will be evaluated to assess sleepiness during the night shift including the commute to and from work.)
  5. The patient is in good health as determined by a medical and psychiatric history, medical examination, electrocardiogram (ECG), serum chemistry and hematology. Women must be surgically sterile, 2 years postmenopausal, or if of childbearing potential, must use 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]).
  6. The patient may have been prescribed PROVIGIL or stimulant therapy to treat the sleep disorder; however, they must have undergone a washout period of at least 7 days prior to screening assessments.
  7. 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:

  1. have any clinically significant, uncontrolled medical conditions (treated or untreated)
  2. have a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or chronic SWSD
  3. consume caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine or more than 8 cups of coffee per day
  4. used any prescription drugs disallowed by the protocol or clinically significant use of over-the-counter (OTC) drugs within 7 days before the baseline visit
  5. 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)
  6. have a positive UDS at the screening visit
  7. have a clinically significant deviation from normal in the physical examination
  8. are pregnant or lactating. Any woman becoming pregnant during the study will be withdrawn from the study
  9. have used an investigational drug within 1 month before the screening visit
  10. have any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)
  11. have a known clinically significant drug sensitivity to stimulants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00078312

  Hide Study Locations
Locations
United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, United States, 85014
Radiant Research - Tucson
Tucson, Arizona, United States, 85710
United States, Arkansas
Arkansas Center for Sleep Medicine
Little Rock, Arkansas, United States, 72205
Central Arkansas Research
Hot Springs, Arkansas, United States, 71913
United States, California
Anderson Clinical Research
Redlands, California, United States, 92374
Bay Area Research Institute
Lafayette, California, United States, 94549
Synergy Clinical Research Center
San Diego, California, United States, 92105
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Neuro-Therapeutics Inc.
Pasadena, California, United States, 91105
BMR HealthQuest Clinical Trials
San Diego, California, United States, 92123
United States, Colorado
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, United States, 80033
United States, Florida
Therafirst Medical Centers
Ft. Lauderdale, Florida, United States, 33308
Renstar Medical Research
Ocala, Florida, United States, 34471
Precision Research
Hallandale, Florida, United States, 33009
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, United States, 33707
United States, Idaho
Radiant Research, Boise
Boise, Idaho, United States, 83704
United States, Illinois
Radiant Research, Chicago
Chicago, Illinois, United States, 60610
Radiant Research Alexian Brothers
Elk Grove Village, Illinois, United States, 60007
Herron Medical Center, Ltd.
Chicago, Illinois, United States, 60610
Henry W. Lahmeyer, MD and Associates
Northfield, Illinois, United States, 60093
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66211
United States, Louisiana
NeuroTrials Research of New Orleans, LLC
Metairie, Louisiana, United States, 70001
United States, Maryland
Marc Raphaelson, MD, PA
Frederick, Maryland, United States, 21702
United States, Michigan
Michigan Head-Pain Neurological Institute
Ann Arbor, Michigan, United States, 48104
United States, Nebraska
Somnos Laboratories, Inc
Lincoln, Nebraska, United States, 68510
United States, Nevada
Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89104
United States, New Jersey
CNS Research Institute, PC
Clementon, New Jersey, United States, 08021
United States, New York
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States, 11021
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
North Coast Clinical Trials, Inc
Beachwood, Ohio, United States, 44122
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
Clinical Research Studies
Oklahoma City, Oklahoma, United States, 73109
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Hospital Hospital
Allentown, Pennsylvania, United States, 18105
Center for Sleep Disorders, Inc.
Pottstown, Pennsylvania, United States, 19464
United States, South Carolina
SleepMed of South Carolina
Columbia, South Carolina, United States, 29201
United States, Texas
Radiant Research, San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
Radiant Research
Salt Lake City, Utah, United States, 84107
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004
Russian Federation
Clinic of Neurology and Neurosurgery of Saint Petersburg
Saint Petersburg, Russian Federation, 197 022
Institute of Pulmonology
Moscow, Russian Federation, 105 077
Cardioclinic
Saint Petersburg, Russian Federation, 196 128
City Clinical Hospital No. 81
Moscow, Russian Federation, 127 644
Moscow City Somnological Center
Moscow, Russian Federation, 107 014
United Hospital and Out-patient Clinic of Presidential Medical Center of Russian Federation
Moscow, Russian Federation, 119 285
Institute of Pulmonology
Moscow, Russian Federation, 105 077
Center of Rehabilitation of Presidential Medical Center
Moscow, Russian Federation, 143 088
City Clinical Hospital No. 83
Moscow, Russian Federation, 115 682
Medical Sanitary Unit No. 122 of Saint-Petersburg
Saint-Petersburg, Russian Federation, 194 291
Sponsors and Collaborators
Cephalon
  More Information

No publications provided

Study ID Numbers: C10953/3023/ES/MN
Study First Received: February 23, 2004
Last Updated: September 7, 2007
ClinicalTrials.gov Identifier: NCT00078312     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Cephalon:
Excessive Sleepiness
Narcolepsy
Cataplexy
Sleep Attacks
Obstructive Sleep Apnea
Obstructive Sleep Hypopnea
nCPAP
Chronic Shift Work Sleep Disorder
Chronic SWSD
Circadian Rhythm Disorder
Shift Worker
Cepahlon
Cephalon, Inc
Nuvigil

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Disease
Sleep Disorders, Circadian Rhythm
Apnea
Nervous System Diseases
Sleep Apnea, Obstructive
Respiration Disorders
Disorders of Environmental Origin
Dyssomnias
Sleep Disorders
Chronobiology Disorders
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Respiratory Tract Diseases
Mental Disorders
Narcolepsy
Syndrome
Neurologic Manifestations
Signs and Symptoms, Respiratory
Occupational Diseases

ClinicalTrials.gov processed this record on November 22, 2009