The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS (Obstructive Sleep Apnea/Hypopnea), when administered for up to 12 months. Safety and tolerability will be evaluated throughout the study by means of adverse event information, clinical laboratory test results, vital signs measurements, and body weight and height measurements; quarterly physical examination findings; and 12 lead electrocardiograph (ECG) evaluations at the end of the study. In addition, the cognitive and behavioral effects of PROVIGIL will be assessed quarterly as measured by the Child Behavior Checklist for Ages 6-18 (CBCL/6-18), a brief psychiatric interview, and the Kaufman Brief Intelligence Test (KBIT 2).

Condition	Treatment or Intervention	Phase
Narcolepsy Sleep Apnea, Obstructive	Drug: Modafinil	Phase III

Further Study Details: 

Primary Outcomes: The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS, when administered for up to 12 months.
Secondary Outcomes: The secondary objective of the study is to evaluate long-term effectiveness by using: the Clinical Global Impression of Change (CGI C) ratings for severity of ES and the total score from the Pediatric Daytime Sleepiness Scale (PDSS)
Expected Total Enrollment:  280

PROVIGIL is a registered trademark of Genelco, S.A., licensed to Cephalon, Inc.

Ages Eligible for Study:  6 Years   -   16 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Appropriate written assent is obtained from the patient and written informed consent is obtained from the parent or legal guardian (defined by the IEC/IRB)
• A boy or girl aged 6 through 16 years (at the start of the previous double blind study), inclusive, who participated in study C1538/3027/NA/MN or C1538/3028/AP/MN
• Have a diagnosis (as established in the previous double blind study) of narcolepsy (or presumed narcolepsy) or OSAHS according to the criteria established by the International Classification of Sleep Disorders (ICSD) manual of the American Academy of Sleep Medicine (AASM)
• Continue to be in good health as determined by a medical and psychiatric history, ECGs, physical examination findings, serum chemistry, hematology, and urinalysis
• Have blood pressure values greater than those for the 5th percentile and less than the 95th percentile on the National High Blood Pressure Education Program guidelines for blood pressure levels for boys and girls ages 6 through 16 years
• Girls who are post menarche or sexually active who have a negative urine pregnancy test at the screening/baseline visit, must be using a medically acceptable method of birth control, and must agree to continued use of this method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of birth control include: barrier method with spermicide; steroidal contraceptives (oral, topical [patch], implanted, and injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence
• No positive urine drug screen (UDS) for any illicit drug or alcohol (ethanol) at baseline visit, unless a false positive is suspected, in which case the UDS will be repeated. If the patient has a positive drug screen for methylphenidate or amphetamine at screening; the patient must have a negative UDS after a washout period and prior to baseline.
• Have a parent or legal guardian who is willing to participate in the study
• Continue to meet inclusion criteria from the previous study, as appropriate

Exclusion Criteria:

• Have self induced sleep deprivation/poor sleep hygiene
• Have a past or present seizure disorder (except history of a single febrile seizure), a history of psychosis, or of clinically significant head trauma (eg, brain damage) or past neurosurgery
• Have a history of suicide attempt, or are at suicidal risk
• A clinically significant drug sensitivity to stimulants such as amphetamine, dextroamphetamine, methylphenidate, or pemoline; and modafinil or any of its components
• Any disorder that could interfere with drug absorption, distribution, metabolism, or excretion (including previous gastrointestinal surgery)
• Active, clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other major clinically significant disorder/disease
• Any clinically significant deviation from the normal range(s) in the ECG or physical examination findings, or clinical laboratory (ie, hematology, serum chemistry, urinalysis) test results at the screening/baseline visit
• Absolute neutrophil count (ANC) below the lower limit of normal at the baseline visit (NOTE: If the ANC is below the lower limit of normal at the baseline visit, the medical monitor will be consulted for continued eligibility in the study.)
• A seated pulse outside the range of 60 through 115 bpm after resting for 5 minutes
• A total daily intake of more than 500 mg of caffeine per day (eg, approximately ten 12 ounce caffeinated sodas, 5 cups of coffee or tea, or about 25 ounces of chocolate per day) within 1 week of the baseline visit
• Pregnant or lactating/nursing; any child who becomes pregnant during the study will be withdrawn

Patrick Young      610-738-6587    pjyoung@cephalon.com
Nancy Harvey      610-738-6615    nharvey@cephalon.com

Alabama
      Chris M. Makris, M.D., Birmingham,  Alabama,  35233,  United States; Not yet recruiting
      Robert Doekel, Jr., M.D., Birmingham,  Alabama,  35213,  United States; Not yet recruiting
Arizona
      Barbara Harris, Ph.D., Phoenix,  Arizona,  85050,  United States; Not yet recruiting
      Derek Loewy, Ph.D., Tucson,  Arizona,  85712,  United States; Not yet recruiting
      Stuart Quan, M.D., Tucson,  Arizona,  85724,  United States; Not yet recruiting
Arkansas
      John L. Carroll, M.D., Little Rock,  Arkansas,  72202,  United States; Not yet recruiting
      Joseph McCarty, M.D., Fort Smith,  Arkansas,  72913,  United States; Not yet recruiting
      Samuel Boellner, M.D., Little Rock,  Arkansas,  72205,  United States; Not yet recruiting
California
      Jed Black, M.D., Stanford,  California,  94305,  United States; Not yet recruiting
      Julie Thompson-Dobkin, D.O., Huntington Beach,  California,  92648,  United States; Not yet recruiting
      Lawrence Sher, M.D., Rolling Hills Estates,  California,  90274,  United States; Not yet recruiting
      Mark Buchfuhrer, M.D., Long Beach,  California,  90806,  United States; Not yet recruiting
      Milton K. Erman, M.D., San Diego,  California,  92121,  United States; Not yet recruiting
      Paul Haberman, M.D., Santa Monica,  California,  90404,  United States; Not yet recruiting
      Richard Shubin, M.D., Pasadena,  California,  91105,  United States; Not yet recruiting
      Stuart Menn, M.D., Palm Springs,  California,  92262,  United States; Not yet recruiting
      Yury Furman, M.D., Los Angeles,  California,  90048,  United States; Not yet recruiting
Florida
      Amerigo Padilla, M.D., Miami,  Florida,  33173,  United States; Not yet recruiting
      Martin A. Cohn, M.D., Naples,  Florida,  34110,  United States; Not yet recruiting
Georgia
      Charles Wells, Jr., M.D., Macon,  Georgia,  31208,  United States; Not yet recruiting
      D. Alan Lankford, Ph.D., Atlanta,  Georgia,  30342,  United States; Not yet recruiting
      Gary Montgomery, M.D., Atlanta,  Georgia,  30342,  United States; Not yet recruiting
      Jerry Silverboard, M.D., Atlanta,  Georgia,  30342,  United States; Not yet recruiting
Illinois
      Anna Ivanenko, M.D., Ph.D., Maywood,  Illinois,  60153,  United States; Not yet recruiting
      Henry W. Lahmeyer, MD and Associates, Northfield,  Illinois,  60093,  United States; Not yet recruiting
      Michael Kohrman, M.D., Chicago,  Illinois,  60637,  United States; Not yet recruiting
      Stephen H. Sheldon, D.O., FAAP, Chicago,  Illinois,  60614,  United States; Not yet recruiting
Indiana
      James Cook, M.D., Danville,  Indiana,  46122,  United States; Not yet recruiting
Kansas
      William Leeds, D.O., Topeka,  Kansas,  66606,  United States; Not yet recruiting
Kentucky
      Karen Waters, M.D., Louisville,  Kentucky,  40202,  United States; Not yet recruiting
Louisiana
      Margaret Ann Springer, M.D., Shreveport,  Louisiana,  71103,  United States; Not yet recruiting
Maryland
      Helene A. Emsellem, M.D., Chevy Chase,  Maryland,  20815,  United States; Not yet recruiting
Michigan
      Daniela Minecan, M.D., Ann Arbor,  Michigan,  48109,  United States; Not yet recruiting
      George Zureikat, M.D., Flint,  Michigan,  48503,  United States; Not yet recruiting
Mississippi
      John Harsh, Ph.D., DABSM, Hattiesburg,  Mississippi,  39401,  United States; Not yet recruiting
Missouri
      Pradeep Sahota, M.D., Columbia,  Missouri,  65212,  United States; Not yet recruiting
Nevada
      William Torch, M.D., MS, Reno,  Nevada,  89502,  United States; Not yet recruiting
New Jersey
      Kathleen Ryan, M.D., Mount Laurel,  New Jersey,  08054,  United States; Not yet recruiting
      Lee Brooks, M.D., Princeton,  New Jersey,  08540,  United States; Not yet recruiting
      Marc Seelagy, M.D., Trenton,  New Jersey,  08629,  United States; Not yet recruiting
      Monroe Karetzky, M.D., Newark,  New Jersey,  07112,  United States; Not yet recruiting
New York
      Gary Zammit, M.D., New York,  New York,  10025,  United States; Not yet recruiting
North Carolina
      James Lee, M.D., Charlotte,  North Carolina,  28226,  United States; Not yet recruiting
Ohio
      Bruce Corser, M.D., Cincinnati,  Ohio,  45219,  United States; Not yet recruiting
      Markus H. Schmidt, M.D., Ph.D., Dublin,  Ohio,  43017,  United States; Not yet recruiting
      Martin Scharf, Ph.D., Cincinnati,  Ohio,  45246,  United States; Not yet recruiting
      Michael Neeb, Ph.D., Toledo,  Ohio,  43608,  United States; Not yet recruiting
      Raouf Amin, MD, Cincinnati,  Ohio,  45229,  United States; Not yet recruiting
Oklahoma
      Jorg Pahl, M.D., Oklahoma City,  Oklahoma,  73118,  United States; Not yet recruiting
      William C. Orr, Ph.D., Oklahoma City,  Oklahoma,  73112,  United States; Not yet recruiting
Oregon
      Dainis Irbe, M.D., Eugene,  Oregon,  97401,  United States; Not yet recruiting
Pennsylvania
      Guillermo Borrero, M.D., Clairton,  Pennsylvania,  15025,  United States; Not yet recruiting
      Jeffery Gould, M.D., Bethlehem,  Pennsylvania,  18015,  United States; Not yet recruiting
      William Pistone, M.D., Allentown,  Pennsylvania,  18104,  United States; Not yet recruiting
Rhode Island
      Judith Owens, M.D., MPH, Providence,  Rhode Island,  02903,  United States; Not yet recruiting
South Carolina
      Richard Bogan, M.D., FCCP, Columbia,  South Carolina,  29201,  United States; Recruiting
Tennessee
      Julie Jacques, D.O., Morristown,  Tennessee,  37814,  United States; Not yet recruiting
Texas
      David Sperry, M.D., Dallas,  Texas,  75230,  United States; Not yet recruiting
      Jerry J. Tomasovic, M.D., San Antonio,  Texas,  78258,  United States; Not yet recruiting
      John Hudson, M.D., Austin,  Texas,  78756,  United States; Not yet recruiting
      Todd J. Swick, M.D., Houston,  Texas,  77024,  United States; Recruiting
Utah
      James M. Ferguson, M.D., Salt Lake City,  Utah,  84107,  United States; Not yet recruiting
      Radiant Research, Salt Lake City, Salt Lake City,  Utah,  84107-7591,  United States; Not yet recruiting
Washington
      Ralph A. Pascualy, M.D., Seattle,  Washington,  98122,  United States; Not yet recruiting
Canada, Alberta
      Adam Moscovitch, M.D., Calgary,  Alberta,  T2X2A8,  Canada; Not yet recruiting
Canada, Ontario
      Allen Denys, M.D., Windsor,  Ontario,  N9A1C9,  Canada; Not yet recruiting
      Colin Shapiro, Ph.D., Toronto,  Ontario,  M5T2S8,  Canada; Not yet recruiting
      Leonid Kayumov, M.D., Scarborough,  Ontario,  M1S1T7,  Canada; Not yet recruiting
      Mortimer Mamelak, M.D., Toronto,  Ontario,  M2J2K9,  Canada; Not yet recruiting

Study ID Numbers:  C1538/3029/ES/MN-Open label
Record last reviewed:  April 2005
Last Updated:  April 8, 2005
Record first received:  April 8, 2005
ClinicalTrials.gov Identifier:  NCT00107848
Health Authority: United States: Food and Drug Administration; Canada: Health Canada (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-14