The primary objective of this study is to determine whether treatment with CEP-10953 is more effective than placebo treatment for patients with residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30 minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI C) ratings (as related to general condition) at week 12 (or last postbaseline visit).

Condition	Treatment or Intervention	Phase
Obstructive Sleep Apnea Sleep Hypopnea	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: (a) Written informed consent is obtained. (b) The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive). (c) The patient has a complaint of excessive sleepiness despite nCPAP therapy being effective and being a regular user of nCPAP therapy. (d) The patient has a current diagnosis of OSAHS according to International Classification of Sleep Disorders (ICSD) criteria. (e) The patient meets the following nCPAP therapy requirements: —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 shown to be effective, with effectiveness defined as having an apnea hypopnea index (AHI) of 10 or less during nocturnal PSG, and, in the opinion of the investigator, nCPAP is effective therapy. —Following demonstration of effectiveness, evidence of regular nCPAP usage must be shown during a 2 week evaluation period (ie, nCPAP usage for at least 4 hours/night on at least 70% of the nights). (f) The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology. (g) 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. (h) The patient has a Clinical Global Impression of Severity of Illness (CGI S) rating of 4 or more. (i) The patient has an ESS score of 10 or more. (j) The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness. (k) The patient is able to complete self rating scales and computer based testing. (l) 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: (a) has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated) (b) has a probable diagnosis of a current sleep disorder other than OSAHS (c) consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day (d) used any prescription drugs disallowed by the protocol or clinically significant use of over the counter (OTC) drugs within 14 days before the second screening visit (e) 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) (f) has a positive urine drug screen (UDS) (g) has a clinically significant deviation from normal in the physical examination (h) is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.) (i) has used an investigational drug within 1 month before the initial screening visit (j) has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery) (k) has a known clinically significant drug sensitivity to stimulants or modafinil

Arizona
      PsyPharma Clinical Research Inc., Tuscon,  Arizona,  85712,  United States; Recruiting
California
      Pacific Sleep Medicine Services, Inc, Los Angeles,  California,  90048,  United States; Recruiting
      Pacific Sleep Medicine Services, Inc., San Diego,  California,  92121,  United States; Recruiting
      Southwestern Research, Inc., La Palma,  California,  90623,  United States; Recruiting
Florida
      PAB Clinical Research, Brandon,  Florida,  33511,  United States; Recruiting
      Sleep-Wake Disorder Center of Winter Park, Winter Park,  Florida,  32789,  United States; Recruiting
      Clinical Physiology Associates, Fort Myers,  Florida,  33916,  United States; Recruiting
      Florida Medical Research Institute, Inc., Gainesville,  Florida,  32605,  United States; Recruiting
Georgia
      Atlanta Institute for Medical Research, Inc., Decatur,  Georgia,  30030,  United States; Recruiting
Illinois
      Peoria Pulmonary Associates, Ltd., Peoria,  Illinois,  61603,  United States; Recruiting
Indiana
      Indiana University Medical Center, Indianapolis,  Indiana,  46202,  United States; Recruiting
      The Center for Sleep & Wake Disorders, Danville,  Indiana,  46122,  United States; Recruiting
Kansas
      Topeka Pulmonary, Topeka,  Kansas,  66606,  United States; Recruiting
Kentucky
      Graves-Gilbert Clinic, Bowling Green,  Kentucky,  42101,  United States; Recruiting
      Community Research & Sleep Management Institute, Crestview Hills,  Kentucky,  41017,  United States; Recruiting
Louisiana
      Northshore Research Associates, Slidell,  Louisiana,  70461,  United States; Recruiting
      NeuroTrials Research of New Orleans, Metaire,  Louisiana,  70001,  United States; Recruiting
Maryland
      Union Hospital Sleep Disorders Center, Elkton,  Maryland,  21921,  United States; Recruiting
Missouri
      Washington University Multidisciplinary Sleep Medicine Center, St. Louis,  Missouri,  63108,  United States; Not yet recruiting
      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
North Dakota
      St. Alexius Medical Center, Bismarck,  North Dakota,  58501,  United States; Recruiting
Ohio
      Tri-State Sleep Disorders Center, Cincinnati,  Ohio,  45246,  United States; Recruiting
      Southwest Cleveland Sleep Center, Middleburg Heights,  Ohio,  44130,  United States; Recruiting
Oklahoma
      Clinical Pharmaceutical Trials, Inc., Tulsa,  Oklahoma,  74104,  United States; Not yet recruiting
      Clinical Pharmaceutical Trials, Inc., Tulsa,  Oklahoma,  74104,  United States; Recruiting
Pennsylvania
      Consolidated Clinical Trials, Inc., Pittsburgh,  Pennsylvania,  15221,  United States; Recruiting
      Capital Region Sleep Disorders Center, Carlisle,  Pennsylvania,  17013,  United States; Recruiting
Rhode Island
      Omega Medical Research, Warwick,  Rhode Island,  02886,  United States; Recruiting
South Carolina
      Lowcounty Lung & Critical Care, PA, Charleston,  South Carolina,  29406,  United States; Recruiting
Texas
      Future Search Trials, Austin,  Texas,  78756,  United States; Recruiting
      Todd J. Swick, MD, PA, Houston,  Texas,  77024,  United States; Recruiting
Wisconsin
      Allegiance Research Specialists, Wauwatosa,  Wisconsin,  53226,  United States; Recruiting
Australia, New South Wales
      Woolcock Institute of Medical Research, Sydney,  New South Wales,  2050,  Australia; Recruiting
      MD, PhD, MB, BS, FRACP, Kogarah,  New South Wales,  2217,  Australia; Recruiting
      Westmead Hospital, Westmead,  New South Wales,  2145,  Australia; Recruiting
Australia, South Australia
      Royal Adelaide Hospital, Adelaide,  South Australia,  5000,  Australia; Recruiting
Australia, Victoria
      Monash Medical Center, Melbourne,  Victoria,  3168,  Australia; Recruiting
      Melbourne Sleep Disorders Centre, East Melbourne,  Victoria,  3002,  Australia; Recruiting
France
      Hôpital Antoine Béclère, Clamart Cedex,  92141,  France; Recruiting
      CHU - Hôpital Albert Michallon, Grenoble Cedex 9,  38043,  France; Recruiting
      Hôpital Henri Mondor, Créteil,  94010,  France; Recruiting
Germany
      Klinikum der Phillips Universität, Marburg,  35033,  Germany; Recruiting
      University of Regensburg, Regensburg,  93042,  Germany; Recruiting
Puerto Rico
      SomniCare Sleep Institute, San Juan,  00918,  Puerto Rico; Recruiting
Russian Federation
      United Hospital and Out-patient Clinic of Presidential Medical Center of Russian Federation, Moscow,  119 285,  Russian Federation; Recruiting
      Clinical Hospital with Out-patient Clinic of Russian Science Academy Saint Petersburg, Saint Petersburg,  194 017,  Russian Federation; Recruiting
      Clinical Hospital with Out-patient Clinic of Russian Science Academy Saint Petersburg, Saint Petersburg,  194 017,  Russian Federation; Recruiting
      Medical Sanitary Unit No. 122 of Saint-Petersburg, Saint Petersburg,  194 291,  Russian Federation; Recruiting
      United Hospital and Out-patient Clinic of Presidential Medical Center of Russian Federation, Moscow,  119 285,  Russian Federation; Recruiting
      City Clinical Hospital No. 83, Moscow,  115 682,  Russian Federation; Recruiting

Study ID Numbers:  C10953/3025/AP/MN
Record last reviewed:  July 2004
Record first received:  March 10, 2004
ClinicalTrials.gov Identifier:  NCT00079677
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-18