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

May 8, 2014 updated by: Cephalon

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2X2A8
        • Adam Moscovitch, M.D.
    • Ontario
      • Scarborough, Ontario, Canada, M1S1T7
        • Leonid Kayumov, M.D.
      • Toronto, Ontario, Canada, M2J2K9
        • Mortimer Mamelak, M.D.
      • Windsor, Ontario, Canada, N9A1C9
        • Allen Denys, M.D.
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Robert Doekel, Jr., M.D.
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Derek Loewy, Ph.D.
      • Tucson, Arizona, United States, 85724
        • Stuart Quan, M.D.
    • Arkansas
      • Fort Smith, Arkansas, United States, 72913
        • Joseph McCarty, M.D.
      • Little Rock, Arkansas, United States, 72202
        • John L. Carroll, M.D.
    • California
      • Huntington Beach, California, United States, 92648
        • Julie Thompson-Dobkin, D.O.
      • Long Beach, California, United States, 90806
        • Mark Buchfuhrer, M.D.
      • Los Angeles, California, United States, 90048
        • Yury Furman, M.D.
      • Palm Springs, California, United States, 92262
        • Stuart Menn, M.D.
      • Pasadena, California, United States, 91105
        • Richard Shubin, M.D.
      • Rolling Hills Estates, California, United States, 90274
        • Lawrence Sher, M.D.
      • San Diego, California, United States, 92121
        • Milton K. Erman, M.D.
      • San Francisco, California, United States, 94109
        • Stephen Brooks, M.D.
      • Santa Monica, California, United States, 90404
        • Paul Haberman, M.D.
      • Stanford, California, United States, 94305
        • Jed Black, M.D.
    • Florida
      • Miami, Florida, United States, 33173
        • Amerigo Padilla, M.D.
      • Naples, Florida, United States, 34110
        • Martin A. Cohn, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • D. Alan Lankford, Ph.D.
      • Atlanta, Georgia, United States, 30342
        • Gary Montgomery, M.D.
      • Atlanta, Georgia, United States, 30342
        • Jerry Silverboard, M.D.
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Stephen H. Sheldon, D.O., FAAP
      • Chicago, Illinois, United States, 60637
        • Michael Kohrman, M.D.
      • Maywood, Illinois, United States, 60153
        • Anna Ivanenko, M.D., Ph.D.
      • Northfield, Illinois, United States, 60093
        • Henry Lahmeyer, M.D.
    • Indiana
      • Danville, Indiana, United States, 46122
        • James Cook, M.D.
    • Kansas
      • Topeka, Kansas, United States, 66606
        • William Leeds, D.O.
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Karen Waters, M.D.
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Margaret Ann Springer, M.D.
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Helene A. Emsellem, M.D.
      • Frederick, Maryland, United States, 21702
        • Marc Raphaelson, M.D.
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Daniela Minecan, M.D.
      • Flint, Michigan, United States, 48503
        • George Zureikat, M.D.
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Pradeep Sahota, M.D.
    • Nevada
      • Reno, Nevada, United States, 89502
        • William Torch, M.D., MS
    • New Jersey
      • Mount Laurel, New Jersey, United States, 08054
        • Kathleen Ryan, M.D.
      • New Brunswick, New Jersey, United States, 08903
        • Sushmita Mikkilineni, M.D.
      • Newark, New Jersey, United States, 07112
        • Monroe Karetzky, M.D.
      • Princeton, New Jersey, United States, 08540
        • Lee Brooks, M.D.
      • Trenton, New Jersey, United States, 08629
        • Marc Seelagy, M.D.
    • New York
      • New York, New York, United States, 10025
        • Gary Zammit, M.D.
    • North Carolina
      • Charlotte, North Carolina, United States, 28226
        • James Lee, M.D.
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Raouf Amin, MD
      • Cincinnati, Ohio, United States, 45246
        • Martin Scharf, Ph.D.
      • Dublin, Ohio, United States, 43017
        • Markus H. Schmidt, M.D., Ph.D.
      • Toledo, Ohio, United States, 43608
        • Michael Neeb, Ph.D.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • William C. Orr, Ph.D.
      • Oklahoma City, Oklahoma, United States, 73118
        • Jorg Pahl, M.D.
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Dainis Irbe, M.D.
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • William Pistone, M.D.
      • Bethlehem, Pennsylvania, United States, 18015
        • Jeffery Gould, M.D.
      • Clairton, Pennsylvania, United States, 15025
        • Guillermo Borrero, M.D.
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Judith Owens, M.D., MPH
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Richard Bogan, M.D., FCCP
    • Tennessee
      • Morristown, Tennessee, United States, 37814
        • Julie Jacques, D.O.
    • Texas
      • Austin, Texas, United States, 78756
        • John Hudson, M.D.
      • Dallas, Texas, United States, 75230
        • David Sperry, M.D.
      • Houston, Texas, United States, 77024
        • Todd J. Swick, M.D.
      • San Antonio, Texas, United States, 78258
        • Jerry J. Tomasovic, M.D.
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • James M. Ferguson, M.D.
    • Washington
      • Seattle, Washington, United States, 98122
        • Ralph A. Pascualy, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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 Clinical Global Impression of Change (CGI-C) ratings for ES, at the last post baseline observation (week 6 or early termination)

Secondary Outcome Measures

Outcome Measure
The Clinical Global Impression of Change (CGI-C) ratings for severity of ES
The total score from the Pediatric Daytime Sleepiness Scale (PDSS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cephalon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

April 8, 2005

First Submitted That Met QC Criteria

April 8, 2005

First Posted (Estimate)

April 11, 2005

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1538/3028/AP/MN-OSAHS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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