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NarcolepsyPhase 3NCT00107848

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

A Phase 3 study testing Modafinil in people with Narcolepsy and Sleep Apnea, Obstructive, run by Cephalon at 61 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Narcolepsy, Sleep Apnea, Obstructive
What is being tested?
Modafinil
How many people
280 participants
Where
61 sitesin 2 countries
Study dates
Oct 2004to Sep 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

61 sites in 2 countries.

61 sites in 2 countries

United States55 sites

  • D. Alan Lankford, Ph.D.

    Atlanta, Georgia, 30342

  • Gary Montgomery, M.D.

    Atlanta, Georgia, 30342

  • Jerry Silverboard, M.D.

    Atlanta, Georgia, 30342

  • John Hudson, M.D.

    Austin, Texas, 78756

  • Robert Doekel, Jr., M.D.

    Birmingham, Alabama, 35213

  • Chris M. Makris, M.D.

    Birmingham, Alabama, 35233

  • Helene A. Emsellem, M.D.

    Chevy Chase, Maryland, 20815

  • Stephen H. Sheldon, D.O., FAAP

    Chicago, Illinois, 60614

  • Michael Kohrman, M.D.

    Chicago, Illinois, 60637

  • Carol Rosen

    Cleveland, Ohio, 44106

  • Richard Bogan, M.D., FCCP

    Columbia, South Carolina, 29201

  • David Sperry, M.D.

    Dallas, Texas, 75230

  • James Cook, M.D.

    Danville, Indiana, 46122

  • James Perlstrom

    Fairfax, Virginia, 22030

  • George Zureikat, M.D.

    Flint, Michigan, 48503

  • Joseph McCarty, M.D.

    Fort Smith, Arkansas, 72913

  • Marc Raphaelson

    Frederick, Maryland, 21702

  • Elias H. Sarkis

    Gainesville, Florida, 32607

  • John Harsh, Ph.D., DABSM

    Hattiesburg, Mississippi, 39401

  • Todd J. Swick, M.D.

    Houston, Texas, 77024

  • Julie Thompson-Dobkin, D.O.

    Huntington Beach, California, 92648

  • Samuel Boellner, M.D.

    Little Rock, Arkansas, 72205

  • Mark Buchfuhrer, M.D.

    Long Beach, California, 90806

  • Yury Furman, M.D.

    Los Angeles, California, 90048

  • Karen Waters, M.D.

    Louisville, Kentucky, 40202

  • Charles Wells, Jr., M.D.

    Macon, Georgia, 31208

  • Americo Padilla, M.D.

    Miami, Florida, 33173

  • Julie Jacques, D.O.

    Morristown, Tennessee, 37814

  • Kathleen Ryan, M.D.

    Mount Laurel, New Jersey, 08054

  • Martin A. Cohn, M.D.

    Naples, Florida, 34110

  • Gary Zammit, M.D.

    New York, New York, 10025

  • Monroe Karetzky, M.D.

    Newark, New Jersey, 07112

  • Edward O'Malley

    Norwalk, Connecticut, 06856

  • William C. Orr, Ph.D.

    Oklahoma City, Oklahoma, 73112

  • Jorg Pahl, M.D.

    Oklahoma City, Oklahoma, 73118

  • Stuart Menn, M.D.

    Palm Springs, California, 92262

  • Barbara Harris, Ph.D.

    Phoenix, Arizona, 85050

  • Lee Brooks, M.D.

    Princeton, New Jersey, 08540

  • Judith Owens, M.D., MPH

    Providence, Rhode Island, 02903

  • William Torch, M.D., MS

    Reno, Nevada, 89502

  • Lawrence Sher, M.D.

    Rolling Hills Estates, California, 90274

  • Radiant Research, Salt Lake City

    Salt Lake City, Utah, 84107-7591

  • James M. Ferguson, M.D.

    Salt Lake City, Utah, 84107

  • Jerry J. Tomasovic, M.D.

    San Antonio, Texas, 78258

  • Milton K. Erman, M.D.

    San Diego, California, 92121

  • Joel Greenberg

    Savannah, Georgia, 31405

  • Robert J. Reichler

    Seattle, Washington, 98133

  • Margaret Ann Springer, M.D.

    Shreveport, Louisiana, 71103

  • Jed Black, M.D.

    Stanford, California, 94305

  • Robert M. Cohen

    Stockbridge, Georgia, 30281

  • Michael Neeb, Ph.D.

    Toledo, Ohio, 43608

  • Ramalinga Reddy

    Toledo, Ohio, 43608

  • William Leeds, D.O.

    Topeka, Kansas, 66606

  • Marc Seelagy, M.D.

    Trenton, New Jersey, 08629

  • Derek Loewy, Ph.D.

    Tucson, Arizona, 85712

Other trials in United States

Canada6 sites

  • Adam Moscovitch, M.D.

    Calgary, Alberta, T2X2A8

  • Manisha Witmans

    Edmonton, Alberta, T6G 2B7

  • Lawrence Reinish

    Parry Sound, Ontario, P2A 3A4

  • Leonid Kayumov, M.D.

    Scarborough Village, Ontario, M1S1T7

  • Mortimer Mamelak, M.D.

    Toronto, Ontario, M2J2K9

  • Colin Shapiro, Ph.D.

    Toronto, Ontario, M5T2S8

Other trials in Canada

About this study

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

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).

Read the detailed description

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

Being tested
Modafinil
Keywords
Pediatric Narcolepsy, Pediatric OSA, CPAP, Pediatric Narcolepsy or OSAHS
Medical subject headings
Narcolepsy, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ModafinilDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2005 (estimated)
  2. Study startOct 2004
  3. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Enrolment
280 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00107848
Sponsor's protocol ID
C1538/3029/ES/MN-Open label
Status last verified
May 2014
First submitted
8 Apr 2005
Last updated
9 May 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Modafinil in people with Narcolepsy and Sleep Apnea, Obstructive, run by Cephalon at 61 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00107848.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2014.

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