- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01381718
Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor
A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor
RATIONALE: Modafinil may help improve memory, attention, and fatigue caused by cancer treatment.
PURPOSE: This phase II randomized trial studies how well modafinil works in treating children with memory and attention problems caused by cancer treatment for a brain tumor.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Determine whether a 6-week drug trial of modafinil, compared to placebo, is associated with improvement in neurocognitive function as defined by direct assessment of attention in children with cognitive impairment after treatment for a primary brain tumor.
Secondary
- Determine whether modafinil, compared to placebo, is associated with improved executive function, 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 improved attention, as assessed by the Conners' (3rd Edition) 3 Parent Rating Scale (CPRS-3) - Short Form.
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
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California
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Long Beach, California, United States, 90806
- Miller Children's Hospital
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Palo Alto, California, United States, 94304
- Lucile Packard Children's Hospital Stanford University
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San Diego, California, United States, 92123
- Rady Children's Hospital - San Diego
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Colorado
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Denver, Colorado, United States, 80218
- Children's Hospital of Colorado; Saint Joseph Hospital
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Connecticut
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Hartford, Connecticut, United States, 06106
- Connecticut Children's Medical Center
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Delaware
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Wilmington, Delaware, United States, 19803
- A. I. Dupont Hospital For Children
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District of Columbia
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Washington, District of Columbia, United States, 20010-2970
- Children's National Medical Center
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Florida
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Fort Myers, Florida, United States, 33908
- Lee Memorial Health System
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Gainesville, Florida, United States, 32610
- University of Florida
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Hollywood, Florida, United States, 33021
- Joe DiMaggio Children's Hospital
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Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic
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Orlando, Florida, United States, 32827
- Nemours Children's Hospital
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Pensacola, Florida, United States, 32207
- Nemours Children's Clinic- Pensacola
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Saint Petersburg, Florida, United States, 33701
- All Children's Hospital
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Tampa, Florida, United States, 33606
- Tampa General Hospital
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Tampa, Florida, United States, 33612
- SunCoast CCOP Research Base at the University of South Florida
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Kapiolani Medical Center for Women and Children
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Idaho
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Boise, Idaho, United States, 83712
- St. Luke's Mountain States Tumor Institute
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
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Indiana
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Indianapolis, Indiana, United States, 46163
- Riley Hospital for Children- Indiana University
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Kentucky
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Louisville, Kentucky, United States, 40202
- Kosair Children's Hospital
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
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Michigan
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Ann Arbor, Michigan, United States, 48109
- CS Mott/University of Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Children's Hospitals and Clinics of Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi
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Missouri
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Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital and Clinics
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Saint Louis, Missouri, United States, 63110
- Saint Louis University Cancer Center
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Saint Louis, Missouri, United States, 63104
- Saint Louis University / Cardinal Glennon Children's Medical Center
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Nevada
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Las Vegas, Nevada, United States, 89106
- Nevada Cancer Research Foundation
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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New Brunswick, New Jersey, United States, 08901
- Saint Peter's University Hospital
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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New York, New York, United States, 10016
- New York University Langone Medical Center
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical University
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Ohio
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Akron, Ohio, United States, 44308
- Children's Hospital Medical Center of Akron
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Dayton, Ohio, United States, 45404
- Dayton Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Portland, Oregon, United States, 97329
- Doernbecher Children's Hospital/ Oregoon Health Science University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States, 19320
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, United States, 15224
- Children's Hospital of Pittsburgh of UPMC
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Tennessee
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Knoxville, Tennessee, United States, 37916
- East Tennessee Children's Hospital
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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Nashville, Tennessee, United States, 37232
- Vanderbilt Children's Hospital
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Texas
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Corpus Christi, Texas, United States, 78411
- Driscoll Children's Hospital
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Dallas, Texas, United States, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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San Antonio, Texas, United States, 78229-3900
- University of Texas Health Science Center at San Antonio
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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Norfolk, Virginia, United States, 23507
- Children's Hospital of the King's Daughters
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Wisconsin
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Green Bay, Wisconsin, United States, 54301
- St. Vincent Hospital
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Milwaukee, Wisconsin, United States, 53226
- Midwest Children's Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
- Age ≥ 6 years and ≤ 18 years 10 months at the time of study entry (so that participants will be < 19 at the 6 week evaluation, which is the upper age limit for which the included instruments are valid).
Diagnosis of a primary brain tumor treated with at least one of the following:
- neurosurgical resection of the brain tumor;
- cranial irradiation; or
- any chemotherapy to treat the brain tumor.
- Off-treatment and progression-free for at least 12 months and ≤ 14 years. Treatment cessation is defined as the final dose of chemotherapy, the last dose (fraction) of radiation or date of surgery, whichever occurred last.
- Parent/Legal Guardian and child able to read English or Spanish.
- Vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for valid test administration and cooperation with examinations.
- Availability of a reliable parent or legal guardian who is willing and able to complete all of the outcome measures and fulfill the requirements of the study, including administration of medications and accompanying the participant to all study visits.
- Females of childbearing potential must have a negative pregnancy test result and must agree to use a medically acceptable method of contraception throughout the entire study period and for 30 days after the last dose of study drug.
- Childbearing potential is defined as girls who are >Tanner stage 2, except for those who have documented pan pituitary insufficiency or other hormonal state incompatible with pregnancy.
- Urine pregnancy tests are acceptable.
EXCLUSION CRITERIA:
- Off treatment > 14 years
- Inability to perform the testing procedure (for example, because of aphasia, motor deficits affecting the dominant hand, or IQ < 70)
- Known cardiac disorders including arrhythmias, hypertension requiring treatment or structural heart disease
- Diagnosis of narcolepsy, sick sinus syndrome, arrhythmia or prolonged QTc
- History of stroke or head injury associated with loss of consciousness within 12 months of registration
- History of grade 2 depression or anxiety or treatment with antidepressants, antipsychotics or MAO inhibitors within 30 days of registration
- Concurrent treatment with any medications or substances that are potent inhibitors or inducers of CYP3A4, hepatic enzyme inducing antiepileptic drugs (EIAEDs),or other drugs known to affect the metabolism of modafinil. Examples include but are not limited to itraconazole, ketoconazole, doxycycline, rifampin, St. John's wort, phenytoin, phenobarbital, diazepam, tricyclic antidepressants.
- If patients were previously taking, EIAEDs, they must be off for > 2 weeks prior to study enrollment.
- Treatment with other stimulant medications within 14 days of registration; however, a diagnosis of ADHD does NOT exclude a child from participation
- Participants with known hypersensitivity to modafinil, armodafinil or any of its components
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm I
Participants receive modafinil orally (PO) once daily (QD) on days 1-42.
|
Given PO
|
PLACEBO_COMPARATOR: Arm II
Participants receive placebo PO QD on days 1-42.
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Given PO
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Age-Adjusted Scores at Week Six From Baseline in the Attention Task of the CogState Battery
Time Frame: Baseline and 6 weeks
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CogState Battery.
CogState is a semi-automated, computerized cognitive testing system that was developed as a rapid and accurate test of cognitive function specifically for repeated assessment that is sensitive to the effects of medication in children over the age of 5 years and in adults from different language, cultural and socio-economic backgrounds.
The CogState tasks to assess processing speed, visual attention, working memory and executive function were used.
The CogState battery was administered in the following order: Detection Task, Identification Task, One Card Learning Task, One Back Task, and lastly, the Modified Groton Maze Learning Task.
It was administered at baseline and 6 weeks.
A positive change from baseline is an improvement.
There is not a minimum or maximum since the value is reported as a z-score, but with the mean = 0 and the SD = 1, the range should be between -3 and 3.
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Baseline and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Reported Adverse Events (AEs)
Time Frame: 30 days post intervention
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AEs gathered using SAFTEE (Systematic Assessment for Treatment Emergent Effects) and participant report on daily log.
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30 days post intervention
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Change in Working Memory Score at 6 Weeks From Baseline as Assessed on BRIEF
Time Frame: Baseline and 6 weeks
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Behavior Rating Inventory of Executive Function (BRIEF).
The BRIEF is a behavior rating scale designed to assess executive functions in the home and school environments.
The measure was selected to provide parent-reported outcomes of problems related to attention, memory and executive function that occur in everyday life.
The instrument was utilized to measure the change in working memory, according to the parent's perspective only, from baseline to 6 weeks.
Scores are linear transformations of raw scores into T scores (mean = 50, SD = 10); higher scores indicate greater difficulties.
The baseline score was subtracted from the 6 week score.
Positive change from baseline is an improvement.
The total scale ranges from 0 to 172.
A T score >60 on the BRIEF working memory subscale indicates cognitive impairment.
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Baseline and 6 weeks
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Change in PedsQL Score at 6 Weeks From Baseline
Time Frame: Baseline and 6 weeks
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PedsQL is Pediatric Quality of Life Inventory Multi-dimensional Fatigue Scale.
This scale is designed as a generic symptom-specific instrument to measure fatigue.
Higher scores indicate fewer symptoms of fatigue.
It was administered at baseline and 6 weeks.
The score is the sum of the answers.
The baseline score was subtracted from the 6 week score.
A positive change indicates worsening.
The scale total score range is from 0-72 for both the parent and patient reported instruments.
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Baseline and 6 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Jeffrey P. Krischer, MD, PhD, University of South Florida
- Study Chair: Nicole J. Ullrich, MD, PhD, Boston Children's Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Poisoning
- Fatigue
- Brain Neoplasms
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Neurotoxicity Syndromes
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Modafinil
Other Study ID Numbers
- SCUSF 0901
- 5U10CA081920-11 (U.S. NIH Grant/Contract)
- SCUSF-0901 (OTHER: SunCoast CCOP Research Base)
- ACCL0922 (OTHER: Children's Oncology Network)
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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