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

Further Study Details: 

Expected Total Enrollment:  300

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

Criteria

Inclusion Criteria:

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

(a) Written informed consent is obtained.

(b) Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) are eligible.

(c) 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.

(d) 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.)

(e) 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]).

(f) 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.

(g) 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:

(a) have any clinically significant, uncontrolled medical conditions (treated or untreated)

(b) have a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or chronic SWSD

(c) 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

(d) 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

(e) 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)

(f) have a positive UDS at the screening visit

(g) have a clinically significant deviation from normal in the physical examination

(h) are pregnant or lactating. Any woman becoming pregnant during the study will be withdrawn from the study

(i) have used an investigational drug within 1 month before the screening visit

(j) have any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)

(k) have a known clinically significant drug sensitivity to stimulants

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

Study ID Numbers:  C10953/3023/ES/MN
Record last reviewed:  February 2005
Last Updated:  February 15, 2005
Record first received:  February 23, 2004
ClinicalTrials.gov Identifier:  NCT00078312
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08