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).
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.
Chris M. Makris, M.D., Birmingham, Alabama 35233, United States
Robert Doekel, Jr., M.D., Birmingham, Alabama 35213, United States
Adam Moscovitch, M.D., Calgary, Alberta T2X2A8, Canada
Manisha Witmans, Edmonton, Alberta T6G 2B7, Canada
Barbara Harris, Ph.D., Phoenix, Arizona 85050, United States
Derek Loewy, Ph.D., Tucson, Arizona 85712, United States
Joseph McCarty, M.D., Fort Smith, Arkansas 72913, United States
Samuel Boellner, M.D., Little Rock, Arkansas 72205, United States
Jed Black, M.D., Stanford, California 94305, United States
Julie Thompson-Dobkin, D.O., Huntington Beach, California 92648, United States
Lawrence Sher, M.D., Rolling Hills Estates, California 90274, United States
Mark Buchfuhrer, M.D., Long Beach, California 90806, United States
Milton K. Erman, M.D., San Diego, California 92121, United States
Stuart Menn, M.D., Palm Springs, California 92262, United States
Yury Furman, M.D., Los Angeles, California 90048, United States
Edward O'Malley, Norwalk, Connecticut 06856, United States
Americo Padilla, M.D., Miami, Florida 33173, United States
Martin A. Cohn, M.D., Naples, Florida 34110, United States
Elias H. Sarkis, Gainesville, Florida 32607, United States
Charles Wells, Jr., M.D., Macon, Georgia 31208, United States
D. Alan Lankford, Ph.D., Atlanta, Georgia 30342, United States
Gary Montgomery, M.D., Atlanta, Georgia 30342, United States
Jerry Silverboard, M.D., Atlanta, Georgia 30342, United States
Robert M. Cohen, Stockbridge, Georgia 30281, United States
Joel Greenberg, Savannah, Georgia 31405, United States
Michael Kohrman, M.D., Chicago, Illinois 60637, United States
Stephen H. Sheldon, D.O., FAAP, Chicago, Illinois 60614, United States
James Cook, M.D., Danville, Indiana 46122, United States
William Leeds, D.O., Topeka, Kansas 66606, United States
Karen Waters, M.D., Louisville, Kentucky 40202, United States
Margaret Ann Springer, M.D., Shreveport, Louisiana 71103, United States
Helene A. Emsellem, M.D., Chevy Chase, Maryland 20815, United States
Marc Raphaelson, Frederick, Maryland 21702, United States
George Zureikat, M.D., Flint, Michigan 48503, United States
John Harsh, Ph.D., DABSM, Hattiesburg, Mississippi 39401, United States
William Torch, M.D., MS, Reno, Nevada 89502, United States
Kathleen Ryan, M.D., Mount Laurel, New Jersey 08054, United States
Lee Brooks, M.D., Princeton, New Jersey 08540, United States
Marc Seelagy, M.D., Trenton, New Jersey 08629, United States
Monroe Karetzky, M.D., Newark, New Jersey 07112, United States
Gary Zammit, M.D., New York, New York 10025, United States
Michael Neeb, Ph.D., Toledo, Ohio 43608, United States
Ramalinga Reddy, Toledo, Ohio 43608, United States
Carol Rosen, Cleveland, Ohio 44106, United States
Jorg Pahl, M.D., Oklahoma City, Oklahoma 73118, United States
William C. Orr, Ph.D., Oklahoma City, Oklahoma 73112, United States
Colin Shapiro, Ph.D., Toronto, Ontario M5T2S8, Canada
Leonid Kayumov, M.D., Scarborough, Ontario M1S1T7, Canada
Mortimer Mamelak, M.D., Toronto, Ontario M2J2K9, Canada
Lawrence Reinish, Parry Sound, Ontario P2A 3A4, Canada
Judith Owens, M.D., MPH, Providence, Rhode Island 02903, United States
Richard Bogan, M.D., FCCP, Columbia, South Carolina 29201, United States
Julie Jacques, D.O., Morristown, Tennessee 37814, United States
David Sperry, M.D., Dallas, Texas 75230, United States
Jerry J. Tomasovic, M.D., San Antonio, Texas 78258, United States
John Hudson, M.D., Austin, Texas 78756, United States
Todd J. Swick, M.D., Houston, Texas 77024, United States
James M. Ferguson, M.D., Salt Lake City, Utah 84107, United States
Radiant Research, Salt Lake City, Salt Lake City, Utah 84107-7591, United States
James Perlstrom, Fairfax, Virginia 22030, United States
Robert J. Reichler, Seattle, Washington 98133, United States
