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

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ClinicalTrials.gov Identifier: NCT00107848
Recruitment Status : Completed
First Posted : April 11, 2005
Last Update Posted : May 9, 2014
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

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).

Condition or disease Intervention/treatment Phase
Narcolepsy Sleep Apnea, Obstructive Drug: Modafinil Phase 3

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 280 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
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
Study Start Date : October 2004
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources




Primary Outcome Measures :
  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 Outcome Measures :
  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)


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107848


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

ClinicalTrials.gov Identifier: NCT00107848     History of Changes
Other Study ID Numbers: C1538/3029/ES/MN-Open label
First Posted: April 11, 2005    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014

Keywords provided by Teva Pharmaceutical Industries:
Pediatric Narcolepsy
Pediatric OSA
CPAP
Pediatric Narcolepsy or OSAHS

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Narcolepsy
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Disorders of Excessive Somnolence
Mental Disorders
Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs