A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor
- Determine whether a 6-week drug trial of modafinil, compared to placebo, is associated
with improvement in neurocognitive function as defined by parent report of inattention
or working memory deficits or by direct assessment of attention, working memory, or
processing speed in children with cognitive impairment after treatment for a primary
- Determine whether modafinil, compared to placebo, is associated with improved executive
function (apart from working memory), as assessed using the BRIEF executive function
and hippocampal learning and executive function tasks from the CogState battery.
- Determine whether modafinil, compared to placebo, is associated with reduced fatigue as
assessed using the PedsQL Multidimensional Fatigue Scale.
- Evaluate the safety of modafinil in this population.
OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive modafinil orally (PO) once daily (QD) on days 1-42.
- Arm II: Participants receive placebo PO QD on days 1-42. Participants complete a
semi-automated, computerized cognitive-testing system (CogState) designed to assess
psychomotor, attention/vigilance, memory, and other components of executive function by
presenting different tasks, each with its own set of rules, at baseline and after
completion of study therapy. Participants also complete the PedsQL Multidimensional
Fatigue Scale (Peds QL-MFS).
Parents or legal guardians complete the PedsQL-MFS, the Conners Parent Reported Scale
(CPR-3), and the Behavior Rating Inventory of Executive Function (BRIEF) at baseline and
after completion of study therapy.
Clinical and/or research staff administer the Systematic Assessment for Treatment Emergency
Events (SAFTEE), a semi-structured interview designed to elicit adverse events, at baseline
and periodically during study.
After completion of study therapy, participants are followed up for 30 days.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Change in age-adjusted scores at week six from baseline in any of the 5 questionnaires
Jeffrey P. Krischer, MD, PhD
University of South Florida
United States: Data and Safety Monitoring Board
|Mayo Clinic||Rochester, Minnesota 55905|
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|MD Anderson Cancer Center Orlando||Orlando, Florida 32806|
|St. Vincent Hospital||Green Bay, Wisconsin 54307-3508|
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|All Children's Hospital||St. Petersburg, Florida 33701|
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Driscoll Children's Hospital||Corpus Christi, Texas 78466|
|University of Illinois at Chicago||Chicago, Illinois 60612|
|Kosair Children's Hospital||Louisville, Kentucky 40202-3830|
|East Tennessee Children's Hospital||Knoxville, Tennessee 37901|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center||New York, New York 10032|
|Vanderbilt Children's Hospital||Nashville, Tennessee 37232-6310|
|Saint Louis University Cancer Center||Saint Louis, Missouri 63110|
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|
|Children's Hospital Boston||Boston, Massachusetts 02115|
|Connecticut Children's Medical Center||Hartford, Connecticut 06106|
|University of California San Francisco||San Francisco, California 941104206|
|Kapiolani Medical Center for Women and Children||Honolulu, Hawaii 96826|
|SUNY Upstate Medical University||Syracuse, New York 13210|
|University of New Mexico||Albuquerque, New Mexico 87131|
|Children's Healthcare of Atlanta||Atlanta, Georgia 30342|
|University of Mississippi||Jackson, Mississippi 39216|
|Children's Mercy Hospital and Clinics||Kansas City, Missouri 64108|
|SunCoast CCOP Research Base at the University of South Florida||Tampa, Florida 33612|
|Lucile Packard Children's Hospital Stanford University||Palo Alto, California 94304|
|Children's Hospital of Colorado; Saint Joseph Hospital||Denver, Colorado 80218|
|Nemours Children's Clinic- Pensacola||Pensacola, Florida 32207|
|Riley Hospital for Children- Indiana University||Indianapolis, Indiana 46163|
|CS Mott/University of Michigan||Ann Arbor, Michigan 48109|
|Doernbecher Children's Hospital/ Oregoon Health Science University||Portland, Oregon 97329|