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

May 8, 2014 updated by: Cephalon

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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.
      • Edmonton, Alberta, Canada, T6G 2B7
        • Manisha Witmans
    • Ontario
      • Parry Sound, Ontario, Canada, P2A 3A4
        • Lawrence Reinish
      • Scarborough, Ontario, Canada, M1S1T7
        • Leonid Kayumov, M.D.
      • Toronto, Ontario, Canada, M2J2K9
        • Mortimer Mamelak, M.D.
      • Toronto, Ontario, Canada, M5T2S8
        • Colin Shapiro, Ph.D.
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Robert Doekel, Jr., M.D.
      • Birmingham, Alabama, United States, 35233
        • Chris M. Makris, M.D.
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • Barbara Harris, Ph.D.
      • Tucson, Arizona, United States, 85712
        • Derek Loewy, Ph.D.
    • Arkansas
      • Fort Smith, Arkansas, United States, 72913
        • Joseph McCarty, M.D.
      • Little Rock, Arkansas, United States, 72205
        • Samuel Boellner, 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.
      • Rolling Hills Estates, California, United States, 90274
        • Lawrence Sher, M.D.
      • San Diego, California, United States, 92121
        • Milton K. Erman, M.D.
      • Stanford, California, United States, 94305
        • Jed Black, M.D.
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Edward O'Malley
    • Florida
      • Gainesville, Florida, United States, 32607
        • Elias H. Sarkis
      • Miami, Florida, United States, 33173
        • Americo 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.
      • Macon, Georgia, United States, 31208
        • Charles Wells, Jr., M.D.
      • Savannah, Georgia, United States, 31405
        • Joel Greenberg
      • Stockbridge, Georgia, United States, 30281
        • Robert M. Cohen
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Stephen H. Sheldon, D.O., FAAP
      • Chicago, Illinois, United States, 60637
        • Michael Kohrman, 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
    • Michigan
      • Flint, Michigan, United States, 48503
        • George Zureikat, M.D.
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • John Harsh, Ph.D., DABSM
    • Nevada
      • Reno, Nevada, United States, 89502
        • William Torch, M.D., MS
    • New Jersey
      • Mount Laurel, New Jersey, United States, 08054
        • Kathleen Ryan, 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.
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Carol Rosen
      • Toledo, Ohio, United States, 43608
        • Michael Neeb, Ph.D.
      • Toledo, Ohio, United States, 43608
        • Ramalinga Reddy
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • William C. Orr, Ph.D.
      • Oklahoma City, Oklahoma, United States, 73118
        • Jorg Pahl, 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.
      • Salt Lake City, Utah, United States, 84107-7591
        • Radiant Research, Salt Lake City
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • James Perlstrom
    • Washington
      • Seattle, Washington, United States, 98133
        • Robert J. Reichler

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Non-Randomized
  • Interventional Model: Single Group Assignment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2004

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C1538/3029/ES/MN-Open label

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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