PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
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
1 other identifier
interventional
280
2 countries
61
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2004
Shorter than P25 for phase_3
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 8, 2005
CompletedFirst Posted
Study publicly available on registry
April 11, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedMay 9, 2014
May 1, 2014
April 8, 2005
May 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (1)
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)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (61)
Robert Doekel, Jr., M.D.
Birmingham, Alabama, 35213, United States
Chris M. Makris, M.D.
Birmingham, Alabama, 35233, United States
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
Julie Thompson-Dobkin, D.O.
Huntington Beach, California, 92648, United States
Mark Buchfuhrer, M.D.
Long Beach, California, 90806, United States
Yury Furman, M.D.
Los Angeles, California, 90048, United States
Stuart Menn, M.D.
Palm Springs, California, 92262, United States
Lawrence Sher, M.D.
Rolling Hills Estates, California, 90274, United States
Milton K. Erman, M.D.
San Diego, California, 92121, United States
Jed Black, M.D.
Stanford, California, 94305, United States
Edward O'Malley
Norwalk, Connecticut, 06856, United States
Elias H. Sarkis
Gainesville, Florida, 32607, United States
Americo Padilla, M.D.
Miami, Florida, 33173, United States
Martin A. Cohn, M.D.
Naples, Florida, 34110, 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
Charles Wells, Jr., M.D.
Macon, Georgia, 31208, United States
Joel Greenberg
Savannah, Georgia, 31405, United States
Robert M. Cohen
Stockbridge, Georgia, 30281, United States
Stephen H. Sheldon, D.O., FAAP
Chicago, Illinois, 60614, United States
Michael Kohrman, M.D.
Chicago, Illinois, 60637, 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
Monroe Karetzky, M.D.
Newark, New Jersey, 07112, United States
Lee Brooks, M.D.
Princeton, New Jersey, 08540, United States
Marc Seelagy, M.D.
Trenton, New Jersey, 08629, United States
Gary Zammit, M.D.
New York, New York, 10025, United States
Carol Rosen
Cleveland, Ohio, 44106, United States
Michael Neeb, Ph.D.
Toledo, Ohio, 43608, United States
Ramalinga Reddy
Toledo, Ohio, 43608, United States
William C. Orr, Ph.D.
Oklahoma City, Oklahoma, 73112, United States
Jorg Pahl, M.D.
Oklahoma City, Oklahoma, 73118, United States
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
John Hudson, M.D.
Austin, Texas, 78756, United States
David Sperry, M.D.
Dallas, Texas, 75230, United States
Todd J. Swick, M.D.
Houston, Texas, 77024, United States
Jerry J. Tomasovic, M.D.
San Antonio, Texas, 78258, United States
Radiant Research, Salt Lake City
Salt Lake City, Utah, 84107-7591, United States
James M. Ferguson, M.D.
Salt Lake City, Utah, 84107, United States
James Perlstrom
Fairfax, Virginia, 22030, United States
Robert J. Reichler
Seattle, Washington, 98133, United States
Adam Moscovitch, M.D.
Calgary, Alberta, T2X2A8, Canada
Manisha Witmans
Edmonton, Alberta, T6G 2B7, Canada
Lawrence Reinish
Parry Sound, Ontario, P2A 3A4, Canada
Leonid Kayumov, M.D.
Scarborough Village, Ontario, M1S1T7, Canada
Mortimer Mamelak, M.D.
Toronto, Ontario, M2J2K9, Canada
Colin Shapiro, Ph.D.
Toronto, Ontario, M5T2S8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 8, 2005
First Posted
April 11, 2005
Study Start
October 1, 2004
Study Completion
September 1, 2005
Last Updated
May 9, 2014
Record last verified: 2014-05