Clinical Trial: PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

This study is currently recruiting patients.

Sponsored by: Cephalon
Information provided by: Cephalon

Purpose

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

MedlinePlus related topics:  Sleep Apnea;   Sleep Disorders

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Uncontrolled, Expanded Access Assignment, Safety Study

Official Title: A 1 Year Open Label, Flexible Dosage Extension Study to Assess the Safety and Continued Effectiveness of PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

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

Study start: October 2004;  Expected completion: September 2006
Last follow-up: September 2005;  Data entry closure: September 2006

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

Eligibility

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

Location and Contact Information

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
 205-558-2433 

      Robert Doekel, Jr., M.D., Birmingham,  Alabama,  35213,  United States; Not yet recruiting
 205-599-1020 

Arizona
      Barbara Harris, Ph.D., Phoenix,  Arizona,  85050,  United States; Not yet recruiting
 602-992-3115 

      Derek Loewy, Ph.D., Tucson,  Arizona,  85712,  United States; Not yet recruiting
 520-318-1122 

      Stuart Quan, M.D., Tucson,  Arizona,  85724,  United States; Not yet recruiting
 520-626-6115 

Arkansas
      John L. Carroll, M.D., Little Rock,  Arkansas,  72202,  United States; Not yet recruiting
 501-364-3577 

      Joseph McCarty, M.D., Fort Smith,  Arkansas,  72913,  United States; Not yet recruiting
 479-478-3610 

      Samuel Boellner, M.D., Little Rock,  Arkansas,  72205,  United States; Not yet recruiting
 501-312-1318 

California
      Jed Black, M.D., Stanford,  California,  94305,  United States; Not yet recruiting
 415-607-7237 

      Julie Thompson-Dobkin, D.O., Huntington Beach,  California,  92648,  United States; Not yet recruiting
 714-596-7667 

      Lawrence Sher, M.D., Rolling Hills Estates,  California,  90274,  United States; Not yet recruiting
 310-989-1940 

      Mark Buchfuhrer, M.D., Long Beach,  California,  90806,  United States; Not yet recruiting
 562-904-1101 

      Milton K. Erman, M.D., San Diego,  California,  92121,  United States; Not yet recruiting
 858-657-0550 

      Paul Haberman, M.D., Santa Monica,  California,  90404,  United States; Not yet recruiting
 310-586-0843 

      Richard Shubin, M.D., Pasadena,  California,  91105,  United States; Not yet recruiting
 626-356-0800 

      Stuart Menn, M.D., Palm Springs,  California,  92262,  United States; Not yet recruiting
 760-416-3505 

      Yury Furman, M.D., Los Angeles,  California,  90048,  United States; Not yet recruiting
 323-653-3434 

Florida
      Amerigo Padilla, M.D., Miami,  Florida,  33173,  United States; Not yet recruiting
 305-598-3125 

      Martin A. Cohn, M.D., Naples,  Florida,  34110,  United States; Not yet recruiting
 239-566-1192 

Georgia
      Charles Wells, Jr., M.D., Macon,  Georgia,  31208,  United States; Not yet recruiting
 478-745-9050 

      D. Alan Lankford, Ph.D., Atlanta,  Georgia,  30342,  United States; Not yet recruiting
 404-256-6545 

      Gary Montgomery, M.D., Atlanta,  Georgia,  30342,  United States; Not yet recruiting
 404-252-7339 

      Jerry Silverboard, M.D., Atlanta,  Georgia,  30342,  United States; Not yet recruiting
 404-256-3535 

Illinois
      Anna Ivanenko, M.D., Ph.D., Maywood,  Illinois,  60153,  United States; Not yet recruiting
 708-216-3273 

      Henry W. Lahmeyer, MD and Associates, Northfield,  Illinois,  60093,  United States; Not yet recruiting
Stacy Sloan  847-446-3531    sloanmalm@comcast.net 
Eric Malm  847-446-3531    sloanmalm@comcast.net 
Henry W. Lahmeyer, MD,  Principal Investigator

      Michael Kohrman, M.D., Chicago,  Illinois,  60637,  United States; Not yet recruiting
 773-702-6487 

      Stephen H. Sheldon, D.O., FAAP, Chicago,  Illinois,  60614,  United States; Not yet recruiting
 773-975-8779 

Indiana
      James Cook, M.D., Danville,  Indiana,  46122,  United States; Not yet recruiting
 317-718-1403 

Kansas
      William Leeds, D.O., Topeka,  Kansas,  66606,  United States; Not yet recruiting
 785-234-5480 

Kentucky
      Karen Waters, M.D., Louisville,  Kentucky,  40202,  United States; Not yet recruiting
 502-852-2448 

Louisiana
      Margaret Ann Springer, M.D., Shreveport,  Louisiana,  71103,  United States; Not yet recruiting
 318-675-5075 

Maryland
      Helene A. Emsellem, M.D., Chevy Chase,  Maryland,  20815,  United States; Not yet recruiting
 301-654-0209 

Michigan
      Daniela Minecan, M.D., Ann Arbor,  Michigan,  48109,  United States; Not yet recruiting
 734-936-7310 

      George Zureikat, M.D., Flint,  Michigan,  48503,  United States; Not yet recruiting
 810-762-7283 

Mississippi
      John Harsh, Ph.D., DABSM, Hattiesburg,  Mississippi,  39401,  United States; Not yet recruiting
 601-266-4611 

Missouri
      Pradeep Sahota, M.D., Columbia,  Missouri,  65212,  United States; Not yet recruiting
 573-882-8040 

Nevada
      William Torch, M.D., MS, Reno,  Nevada,  89502,  United States; Not yet recruiting
 775-329-4060 

New Jersey
      Kathleen Ryan, M.D., Mount Laurel,  New Jersey,  08054,  United States; Not yet recruiting
 856-793-0318 

      Lee Brooks, M.D., Princeton,  New Jersey,  08540,  United States; Not yet recruiting
 609-520-1717 

      Marc Seelagy, M.D., Trenton,  New Jersey,  08629,  United States; Not yet recruiting
 609-581-1400 

      Monroe Karetzky, M.D., Newark,  New Jersey,  07112,  United States; Not yet recruiting
 973-926-7597 

New York
      Gary Zammit, M.D., New York,  New York,  10025,  United States; Not yet recruiting
 212-994-5100 

North Carolina
      James Lee, M.D., Charlotte,  North Carolina,  28226,  United States; Not yet recruiting
 704-542-4544 

Ohio
      Bruce Corser, M.D., Cincinnati,  Ohio,  45219,  United States; Not yet recruiting
 513-721-3868 

      Markus H. Schmidt, M.D., Ph.D., Dublin,  Ohio,  43017,  United States; Not yet recruiting
 614-766-0733 

      Martin Scharf, Ph.D., Cincinnati,  Ohio,  45246,  United States; Not yet recruiting
 513-671-3101 

      Michael Neeb, Ph.D., Toledo,  Ohio,  43608,  United States; Not yet recruiting
 419-251-0591 

      Raouf Amin, MD, Cincinnati,  Ohio,  45229,  United States; Not yet recruiting
 513-636-7945 

Oklahoma
      Jorg Pahl, M.D., Oklahoma City,  Oklahoma,  73118,  United States; Not yet recruiting
 405-525-6500 

      William C. Orr, Ph.D., Oklahoma City,  Oklahoma,  73112,  United States; Not yet recruiting
 405-602-3939 

Oregon
      Dainis Irbe, M.D., Eugene,  Oregon,  97401,  United States; Not yet recruiting
 541-683-3325 

Pennsylvania
      Guillermo Borrero, M.D., Clairton,  Pennsylvania,  15025,  United States; Not yet recruiting
 412-469-7933 

      Jeffery Gould, M.D., Bethlehem,  Pennsylvania,  18015,  United States; Not yet recruiting
 610-866-6614 

      William Pistone, M.D., Allentown,  Pennsylvania,  18104,  United States; Not yet recruiting
 610-530-2900 

Rhode Island
      Judith Owens, M.D., MPH, Providence,  Rhode Island,  02903,  United States; Not yet recruiting
 401-444-4329 

South Carolina
      Richard Bogan, M.D., FCCP, Columbia,  South Carolina,  29201,  United States; Recruiting
 803-251-3093 

Tennessee
      Julie Jacques, D.O., Morristown,  Tennessee,  37814,  United States; Not yet recruiting
 423-581-5925 

Texas
      David Sperry, M.D., Dallas,  Texas,  75230,  United States; Not yet recruiting
 972-566-8600 

      Jerry J. Tomasovic, M.D., San Antonio,  Texas,  78258,  United States; Not yet recruiting
 210-615-2333 

      John Hudson, M.D., Austin,  Texas,  78756,  United States; Not yet recruiting
 512-380-9925 

      Todd J. Swick, M.D., Houston,  Texas,  77024,  United States; Recruiting
 713-465-9282 

Utah
      James M. Ferguson, M.D., Salt Lake City,  Utah,  84107,  United States; Not yet recruiting
 801-261-8930 

      Radiant Research, Salt Lake City, Salt Lake City,  Utah,  84107-7591,  United States; Not yet recruiting
Patient Office  801-261-8930 
James Ferguson, M.D.,  Principal Investigator

Washington
      Ralph A. Pascualy, M.D., Seattle,  Washington,  98122,  United States; Not yet recruiting
 206-386-2020 

Canada, Alberta
      Adam Moscovitch, M.D., Calgary,  Alberta,  T2X2A8,  Canada; Not yet recruiting
 403-254-6400 

Canada, Ontario
      Allen Denys, M.D., Windsor,  Ontario,  N9A1C9,  Canada; Not yet recruiting
 519-258-0585 

      Colin Shapiro, Ph.D., Toronto,  Ontario,  M5T2S8,  Canada; Not yet recruiting
 416-603-5275 

      Leonid Kayumov, M.D., Scarborough,  Ontario,  M1S1T7,  Canada; Not yet recruiting
 416-292-3218 

      Mortimer Mamelak, M.D., Toronto,  Ontario,  M2J2K9,  Canada; Not yet recruiting
 416-236-5650 

More Information

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


Source: ClinicalTrials.gov
Cache Date: April 14, 2005

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