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	Treatment or Intervention	Phase
Narcolepsy	Drug: CEP-10953	Phase III

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  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 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

Alabama
      Sleep Disorders Centers of Alabama, Birmingham,  Alabama,  35213,  United States; Recruiting
California
      Advanced Clinical Research Institute, Anaheim,  California,  92801,  United States; Recruiting
      Pacific Sleep Medicine Services, Inc., San Diege,  California,  92121,  United States; Recruiting
      Pacific Research Network, Inc., San Diego,  California,  92103,  United States; Recruiting
Florida
      Clinical Research Group of St. Petersburg, St. Petersburg,  Florida,  33707,  United States; Recruiting
      Sleep Disorders Center of Sourtwest Florida, Naples,  Florida,  34110,  United States; Recruiting
      Sleep-Wake Disorder Center of Winter Park, Winter Park,  Florida,  32789,  United States; Recruiting
Georgia
      Neurotrials Research Inc., Atlanta,  Georgia,  30342,  United States; Recruiting
      Sleepmed, Inc., Macon,  Georgia,  31201,  United States; Recruiting
Indiana
      The Center for Sleep & Wake Disorders/Midwest Neurology, Danville,  Indiana,  46122,  United States; Recruiting
Kentucky
      Community Research & Sleep Management Institute, Crestview Hills,  Kentucky,  41017,  United States; Recruiting
Maryland
      Center for Sleep and Wake Disorders, Chevy Chase,  Maryland,  20815,  United States; Recruiting
      Center for Sleep & Wake Disorders, Chevy Chase,  Maryland,  20815,  United States; Recruiting
Massachusetts
      Neurocare, Inc., Newton,  Massachusetts,  02459,  United States; Recruiting
Mississippi
      Forrest General Hospital Sleep Disorders Center, Hattiesburg,  Mississippi,  39401,  United States; Recruiting
Missouri
      Washington University Multidisciplinary Sleep Medicine Center, St. Louis,  Missouri,  63108,  United States; Recruiting
New York
      Depression & Anxiety Institute, Mount Kisco,  New York,  10549,  United States; Recruiting
      NYU Sleep Disorders Center, New York,  New York,  10016,  United States; Recruiting
Ohio
      Tri-State Sleep Disorders Center, Cincinnati,  Ohio,  45246,  United States; Recruiting
      Ohio Sleep Medicine and Neuroscience Institute, Inc., Dublin,  Ohio,  43017,  United States; Recruiting
      North Coast Clinical Trials, Inc., Beachwood,  Ohio,  44122,  United States; Recruiting
Oklahoma
      Clinical Pharmaceutical Trials, Inc., Tulsa,  Oklahoma,  74104,  United States; Recruiting
Pennsylvania
      Thomas Jefferson University Sleep Disorders Center at Methodist Hospital, Philadelphia,  Pennsylvania,  19148,  United States; Recruiting
      Capital Region Sleep Disorders Center, Carlisle,  Pennsylvania,  17013,  United States; Recruiting
South Carolina
      SleepMed of South Carolina, Columbia,  South Carolina,  29201,  United States; Recruiting
Texas
      HealthSouth Clinical Research, Conroe,  Texas,  77384,  United States; Recruiting
      Todd Swick, MD, PA, Houston,  Texas,  77024,  United States; Recruiting
Utah
      Radiant Research, Salt Lake City,  Utah,  84107,  United States; Recruiting
Washington
      Swedish Sleep Medicine Institute, Seattle,  Washington,  98122,  United States; Recruiting
Australia, Victoria
      Monash Medical Center, Melbourne,  Victoria,  3168,  Australia; Recruiting
Canada, Manitoba
      Sleep Disorder Centre, Winnipeg,  Manitoba,  R2H 2A6,  Canada; Recruiting
Canada, Ontario
      Toronto West Hospital, Toronto,  Ontario,  M5T 2S8,  Canada; Recruiting
      Ottawa Hospital Civic Campus, Ottawa,  Ontario,  K2A,  Canada; Recruiting
France
      CHU - Hôpital de Rangueil, Toulouse Cedex 9,  31059,  France; Recruiting
      Hôpital Antoine Béclère, Clamart Cedex,  92141,  France; Recruiting
      Hôpitaux Universitaires de Strasbourg - Hôpital Civil, Strasbourg Cedex,  67091,  France; Recruiting
Germany
      Hephata Klinik, Schwalmstadt,  34613,  Germany; Recruiting
      University of Regensburg, Regensburg,  93042,  Germany; Recruiting
      University of Freiburg, Freiburg,  79104,  Germany; Recruiting
Puerto Rico
      Somnicare Sleep Institute, San Juan,  00918,  Puerto Rico; Recruiting

Study ID Numbers:  C10953/3020/NA/MN
Record last reviewed:  July 2004
Record first received:  February 24, 2004
ClinicalTrials.gov Identifier:  NCT00078377
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10