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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00107796
Recruitment Status : Completed
First Posted : April 11, 2005
Last Update Posted : August 24, 2012
Information provided by:
Teva Pharmaceutical Industries

Brief Summary:

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 or disease Intervention/treatment Phase
Narcolepsy Drug: Modafinil Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : October 2004
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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)
  2. The Clinical Global Impression of Change (CGI-C) ratings for ES, at the last post baseline observation (week 6 or early termination)

Secondary Outcome Measures :
  1. Clinical Global Impression of Change (CGI-C) ratings for ES at weeks 3 and 6
  2. Total score from the Pediatric Daytime Sleepiness Scale (PDSS) at weeks 3 and 6, and last postbaseline observation
  3. Mean sleep latency from the MSLT (average of 4 naps performed at 0900, 1100, 1300, and 1500) at week 6

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 Reuptake 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

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 identifier (NCT number): NCT00107796

  Hide Study 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
Stuart Quan, M.D.
Tucson, Arizona, United States, 85724
United States, Arkansas
Joseph McCarty, M.D.
Fort Smith, Arkansas, United States, 72913
John L. Carroll, M.D.
Little Rock, Arkansas, United States, 72202
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
Richard Shubin, M.D.
Pasadena, California, United States, 91105
Lawrence Sher, M.D.
Rolling Hills Estates, California, United States, 90274
Milton K. Erman, M.D.
San Diego, California, United States, 92121
Stephen Brooks, M.D.
San Francisco, California, United States, 94109
Paul Haberman, M.D.
Santa Monica, California, United States, 90404
Jed Black, M.D.
Stanford, California, United States, 94305
United States, Florida
Amerigo 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
United States, Illinois
Stephen H. Sheldon, D.O., FAAP
Chicago, Illinois, United States, 60614
Michael Kohrman, M.D.
Chicago, Illinois, United States, 60637
Anna Ivanenko, M.D., Ph.D.
Maywood, Illinois, United States, 60153
Henry Lahmeyer, M.D.
Northfield, Illinois, United States, 60093
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, M.D.
Frederick, Maryland, United States, 21702
United States, Michigan
Daniela Minecan, M.D.
Ann Arbor, Michigan, United States, 48109
George Zureikat, M.D.
Flint, Michigan, United States, 48503
United States, Mississippi
John Harsh, Ph.D., DABSM
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Pradeep Sahota, M.D.
Columbia, Missouri, United States, 65212
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
Sushmita Mikkilineni, M.D.
New Brunswick, New Jersey, United States, 08903
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, North Carolina
James Lee, M.D.
Charlotte, North Carolina, United States, 28226
United States, Ohio
Bruce Corser, M.D.
Cincinnati, Ohio, United States, 45219
Raouf Amin, MD
Cincinnati, Ohio, United States, 45229
Martin Scharf, Ph.D.
Cincinnati, Ohio, United States, 45246
Carol Rosen, M.D.
Cleveland, Ohio, United States, 44106
Markus H. Schmidt, M.D., Ph.D.
Dublin, Ohio, United States, 43017
Michael Neeb, Ph.D.
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, Oregon
Dainis Irbe, M.D.
Eugene, Oregon, United States, 97401
United States, Pennsylvania
William Pistone, M.D.
Allentown, Pennsylvania, United States, 18104
Jeffery Gould, M.D.
Bethlehem, Pennsylvania, United States, 18015
Guillermo Borrero, M.D.
Clairton, Pennsylvania, United States, 15025
Lee Brooks, M.D.
Philadelphia, Pennsylvania, United States, 19104
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
James M. Ferguson, M.D.
Salt Lake City, Utah, United States, 84107
United States, Washington
Ralph A. Pascualy, M.D.
Seattle, Washington, United States, 98122
Canada, Alberta
Adam Moscovitch, M.D.
Calgary, Alberta, Canada, T2X2A8
Canada, Ontario
Leonid Kayumov, M.D.
Scarborough, Ontario, Canada, M1S1T7
Mortimer Mamelak, M.D.
Toronto, Ontario, Canada, M2J2K9
Colin Shapiro, Ph.D.
Toronto, Ontario, Canada, M5T2S8
Allen Denys, M.D.
Windsor, Ontario, Canada, N9A1C9
Sponsors and Collaborators
Cephalon Identifier: NCT00107796     History of Changes
Other Study ID Numbers: C1538/3027/NA/MN-Narcolepsy
First Posted: April 11, 2005    Key Record Dates
Last Update Posted: August 24, 2012
Last Verified: May 2006

Keywords provided by Teva Pharmaceutical Industries:
Pediatric Narcolepsy
Excessive sleepiness

Additional relevant MeSH terms:
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
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