Clinical Trial: Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

This study is currently recruiting patients.

Sponsored by: Cephalon
Information provided by: Cephalon

Purpose

Primary Objectives: The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with narcolepsy, as assessed by:

  • mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps performed at 0900, 1100, 1300, and 1500) at the last post-baseline observation (week 6 or early termination)
  • the Clinical Global Impression of Change (CGI–C) ratings for ES, at the last post-baseline observation (week 6 or early termination).

Condition Treatment or Intervention Phase
Narcolepsy
 Drug: Modafinil
Phase III

MedlinePlus related topics:  Sleep Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of PROVIGIL ® (Modafinil) Treatment (100, 200, and 400 mg/day) in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

Further Study Details: 
Primary Outcomes: Mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps performed at 0900, 1100, 1300, and 1500) at the last post baseline observation (week 6 or early termination); The Clinical Global Impression of Change (CGI–C) ratings for ES, at the last post baseline observation (week 6 or early termination)
Secondary Outcomes: Clinical Global Impression of Change (CGI-C) ratings for ES at weeks 3 and 6; Total score from the Pediatric Daytime Sleepiness Scale (PDSS) at weeks 3 and 6, and last postbaseline observation; Mean sleep latency from the MSLT (average of 4 naps performed at 0900, 1100, 1300, and 1500) at week 6
Expected Total Enrollment:  140

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

Eligibility

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

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Diagnosis and Main Criteria for Inclusion (Patients are included in the study if all of the following criteria are met):

  • Written informed consent/assent is obtained
  • A boy or girl aged 6 through 16 years, inclusive
  • Meet the minimal criteria established by the International Classification of Sleep Disorders (ICSD) manual of the American Academy of Sleep Medicine (AASM) for narcolepsy (or presumed narcolepsy) as assessed by all of the following: *clinical history; *NPSG (nocturnal polysomnogram) (as evaluated by the investigator) to rule out other sleep disorders (ie, obstructive sleep apnea/hypopnea syndrome [OSAHS] or periodic limb movement with sleep [PLMs]); *narcolepsy (or presumed narcolepsy) as identified by at least 1 of the following: MSLT (as evaluated by the investigator) (mean sleep latency [from 4 naps] <10 minutes); 2 sleep onset REM periods (SOREMP); cataplexy; sleep paralysis; hypnogogic hallucinations -OR- *have a previous diagnosis of narcolepsy on the basis of NPSG and/or MSLT at any time before the screening visit
  • Have ES (MSLT <10 minutes and/or CGI S ≥4) that is not a direct result of inadequate sleep hygiene or other medical disorder
  • Are in good health as determined by a medical and psychiatric history, physical examination, ECG, and clinical laboratory tests
  • Have blood pressure values greater than those for the 5th percentile and less than the 95th percentile for age 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 must have a negative urine pregnancy test prior to the baseline visit, must be using a medically acceptable method of birth control, and must agree to continue 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 contraceptive (eg, oral, transdermal, implanted, or injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence.
  • Be able to swallow a placebo tablet the same size and shape as the study drug tablet
  • Negative UDS (urine drug screen) for any illicit drug, alcohol (ethanol), stimulants, or modafinil at screening; if positive for stimulants or modafinil (prescribed for ES) at the screening visit, UDS to be repeated after a washout period and before the baseline visit
  • Have a parent or legal guardian who is willing to participate in the study

Exclusion Criteria:

Main Criteria for Exclusion (Patients are excluded from participating in this study if 1 or more of the following criteria are met):

  • Have any other disorder(s) that could be considered the primary cause of ES (eg, self induced sleep deprivation)
  • 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
  • Have an average of 5 or more apneic/hypopneic episodes per hour of nocturnal sleep as assessed by NPSG at the baseline visit
  • A clinically significant drug sensitivity to stimulants such as amphetamine, dextroamphetamine, methylphenidate, or pemoline; and/or modafinil or any of its components
  • Use of any prescription (eg, clonidine, guanfacine) or nonprescription (over the counter [OTC]) medications, including dietary supplements with psychoactive properties (eg, any OTC medications or supplements containing ephedrine [ie, ma huang or ephedra], pseudoephedrine, caffeine, or phenylpropanolamine) or sedating properties (ie, antihistamines or sedative hypnotics) within 1 week of the baseline visit (Note: Medications for the treatment of cataplexy will be permitted if the patient has been on a stable dose for at least 1 month.)
  • Use of any MAO (monoamine oxidase) inhibitors or SSRIs (Selective Serotonin Reputake Inhibitors) within 2 weeks of the baseline visit (unless used for cataplexy)
  • Received any investigational drug (except modafinil) within 4 weeks of the baseline visit
  • 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 physical examination or ECG findings, or clinical laboratory test results (ie, serum chemistry, hematology, and urinalysis) at the screening or baseline visit
  • ANC (absolute neutrophil count) below the lower limit of normal at the screening 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.)
  • Seated pulse outside the range of 60 through 115 bpm after resting for 5 minutes
  • A history of alcohol, narcotic, or any other substance abuse or dependence as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM IV) criteria
  • A total daily intake of more than 250 mg of caffeine per day (eg, approximately five 12 ounce caffeinated sodas, 2.5 cups of coffee or tea, or about 12.5 ounces of chocolate per day) within 1 week of the baseline visit
  • Pregnant or lactating/nursing girl; any girl who becomes pregnant during the study will be withdrawn
  • A clinically significant illness within 4 weeks of the baseline visit; or is symptomatic for any clinically significant illness at the screening or baseline visit

Location and Contact Information

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

Alabama
      Robert Doekel, Jr., M.D., Birmingham,  Alabama,  35213,  United States; Recruiting
 205-599-1020 

      Chris M. Makris, M.D., Birmingham,  Alabama,  35233,  United States; Recruiting
 205-558-2433 

Arizona
      Barbara Harris, Ph.D., Phoenix,  Arizona,  85050,  United States; 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
      Samuel Boellner, M.D., Little Rock,  Arkansas,  72205,  United States; Recruiting
 501-312-1318 

      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; Recruiting
 479-478-3610 

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

      Stephen Brooks, M.D., San Francisco,  California,  94109,  United States; Not yet recruiting
 415-229-3190 

      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 

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

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

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

      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 

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

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

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

Georgia
      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; Recruiting
 404-252-7339 

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

      Charles Wells, Jr., M.D., Macon,  Georgia,  31208,  United States; Recruiting
 478-745-9050 

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

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

      Henry Lahmeyer, M.D., Northfield,  Illinois,  60093,  United States; Not yet recruiting
 847-446-3531 

      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 

      Marc Raphaelson, M.D., Frederick,  Maryland,  21702,  United States; Not yet recruiting
 301-698-5606 

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

      Monroe Karetzky, M.D., Newark,  New Jersey,  07112,  United States; Recruiting
 973-926-7597 

      Sushmita Mikkilineni, M.D., New Brunswick,  New Jersey,  08903,  United States; Not yet recruiting
 732-235-7899 

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

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

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

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

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

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

      Carol Rosen, M.D., Cleveland,  Ohio,  44106,  United States; Not yet recruiting
 216-844-4999 

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

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

      Jorg Pahl, M.D., Oklahoma City,  Oklahoma,  73118,  United States; Recruiting
 405-525-6500 

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 

      Lee Brooks, M.D., Philadelphia,  Pennsylvania,  19104,  United States; Not yet recruiting
 215-426-5364 

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

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

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

      Jerry J. Tomasovic, M.D., San Antonio,  Texas,  78258,  United States; Recruiting
 210-615-2333 

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

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 

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

      Mortimer Mamelak, M.D., Toronto,  Ontario,  M2J2K9,  Canada; Recruiting
 416-236-5650 

      Colin Shapiro, Ph.D., Toronto,  Ontario,  M5T2S8,  Canada; Recruiting
 416-603-5275 

More Information

Study ID Numbers:  C1538/3027/NA/MN-Narcolepsy
Record last reviewed:  April 2005
Last Updated:  April 11, 2005
Record first received:  April 8, 2005
ClinicalTrials.gov Identifier:  NCT00107796
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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