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Sleep Apnea, ObstructivePhase 3NCT00107809

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

A Phase 3 study testing Modafinil in people with Sleep Apnea, Obstructive, run by Cephalon at 64 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 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 obstructive sleep apnea/hypopnea syndrome (OSAHS), as assessed by: mean sleep latency from the Multiple Sleep Latency… Read more about this study

Who is it for?
Ages 6 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Apnea, Obstructive
What is being tested?
Modafinil
How many people
140 participants
Where
64 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

  • 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 OSAHS as assessed by all of the following: *clinical history;
  • have a previous diagnosis of OSAHS on the basis of NPSG (nocturnal polysomnogram) and/or MSLT at any time before the screening visit. If the patient is a current user of CPAP (continuous positive airway pressure) therapy and is appropriately titrated on CPAP, the AHI ≥5 inclusion criterion is not applicable; NPSG (nocturnal polysomnogram) (as evaluated by the investigator) to rule out other sleep disorders (ie, narcolepsy and periodic limb movement with sleep [PLMs]).
  • Have ES (CGI-S [Clinical Global Impression of Severity] ≥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
  • For patients who are not current users of CPAP therapy or who are not appropriately titrated on CPAP: have an average of 5 or more apneic/hypopneic episodes per hour of nocturnal sleep, as assessed by the NPSG at the baseline visit (AHI [apnea/hypopnea index] ≥5)
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  • Are currently users of CPAP therapy or have tried and not tolerated the current standards of care for OSAHS and continue to have residual sleepiness (ie, patients who comply with CPAP use, patients who are unable to tolerate or comply with CPAP therapy, patients who have had surgical removal of tonsils and adenoids or for whom this surgery is not warranted, and patients who have attempted or are on an ongoing weight loss program)
  • Have an O2 saturation of at least 85%, based on the investigator's assessment of the patient's health
  • 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 washout period and before the baseline visit
  • Have a parent or legal guardian who is willing to participate in the study

Who cannot join

  • 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 periodic limb movement (PLM) arousal index greater than 5 (ie, >5 PLMs with arousals per hour of sleep)
  • 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/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
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  • Use of any MAO (monoamine oxidase) inhibitors or SSRIs (selective serotonin reuptake inhibitors) within 2 weeks of the baseline visit
  • 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.

Trial locations and contacts

64 sites in 2 countries.

64 sites in 2 countries

United States60 sites

  • William Pistone, M.D.

    Allentown, Pennsylvania, 18104

  • Daniela Minecan, M.D.

    Ann Arbor, Michigan, 48109

  • 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

  • Jeffery Gould, M.D.

    Bethlehem, Pennsylvania, 18015

  • Robert Doekel, Jr., M.D.

    Birmingham, Alabama, 35213

  • James Lee, M.D.

    Charlotte, North Carolina, 28226

  • 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

  • Raouf Amin, MD

    Cincinnati, Ohio, 45229

  • Martin Scharf, Ph.D.

    Cincinnati, Ohio, 45246

  • Guillermo Borrero, M.D.

    Clairton, Pennsylvania, 15025

  • Pradeep Sahota, M.D.

    Columbia, Missouri, 65212

  • Richard Bogan, M.D., FCCP

    Columbia, South Carolina, 29201

  • David Sperry, M.D.

    Dallas, Texas, 75230

  • James Cook, M.D.

    Danville, Indiana, 46122

  • Markus H. Schmidt, M.D., Ph.D.

    Dublin, Ohio, 43017

  • Dainis Irbe, M.D.

    Eugene, Oregon, 97401

  • George Zureikat, M.D.

    Flint, Michigan, 48503

  • Joseph McCarty, M.D.

    Fort Smith, Arkansas, 72913

  • Marc Raphaelson, M.D.

    Frederick, Maryland, 21702

  • Todd J. Swick, M.D.

    Houston, Texas, 77024

  • Julie Thompson-Dobkin, D.O.

    Huntington Beach, California, 92648

  • John L. Carroll, M.D.

    Little Rock, Arkansas, 72202

  • Mark Buchfuhrer, M.D.

    Long Beach, California, 90806

  • Yury Furman, M.D.

    Los Angeles, California, 90048

  • Karen Waters, M.D.

    Louisville, Kentucky, 40202

  • Anna Ivanenko, M.D., Ph.D.

    Maywood, Illinois, 60153

  • Amerigo 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

  • Sushmita Mikkilineni, M.D.

    New Brunswick, New Jersey, 08903

  • Gary Zammit, M.D.

    New York, New York, 10025

  • Monroe Karetzky, M.D.

    Newark, New Jersey, 07112

  • Henry Lahmeyer, M.D.

    Northfield, Illinois, 60093

  • 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

  • Richard Shubin, M.D.

    Pasadena, California, 91105

  • 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

  • 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

  • Stephen Brooks, M.D.

    San Francisco, California, 94109

  • Paul Haberman, M.D.

    Santa Monica, California, 90404

  • Ralph A. Pascualy, M.D.

    Seattle, Washington, 98122

  • Margaret Ann Springer, M.D.

    Shreveport, Louisiana, 71103

  • Jed Black, M.D.

    Stanford, California, 94305

  • Michael Neeb, Ph.D.

    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

  • Stuart Quan, M.D.

    Tucson, Arizona, 85724

Other trials in United States

Canada4 sites

  • Adam Moscovitch, M.D.

    Calgary, Alberta, T2X2A8

  • Leonid Kayumov, M.D.

    Scarborough Village, Ontario, M1S1T7

  • Mortimer Mamelak, M.D.

    Toronto, Ontario, M2J2K9

  • Allen Denys, M.D.

    Windsor, Ontario, N9A1C9

Other trials in Canada

About this study

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 Obstructive Sleep Apnea/Hypopnea Syndrome

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 obstructive sleep apnea/hypopnea syndrome (OSAHS), 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).
Read the detailed description

PROVIGIL is a trademark of Genelco, SA, licensed to Cephalon, Inc.

Being tested
Modafinil
Keywords
Pediatric Obstructive sleep Apnea, Excessive sleepiness, CPAP, Pediatric OSAHS
Medical subject headings
Sleep Apnea, Obstructive, Disorders of Excessive Somnolence

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. 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 outcomes (2)

  1. The Clinical Global Impression of Change (CGI-C) ratings for severity of ES

  2. 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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
140 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00107809
Sponsor's protocol ID
C1538/3028/AP/MN-OSAHS
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 Sleep Apnea, Obstructive, run by Cephalon at 64 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 13 inclusion and 17 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 64 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?

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 study lists 2 primary outcomes in all. 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 NCT00107809.

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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