A Randomized, Phase II Placebo-controlled Study of the Use of Extended-release Methylphenidate or Modafinil for the Treatment of Excessive Daytime Sleepiness in Children Following Cancer Therapy
- Compare the efficacy of methylphenidate hydrochloride and modafinil to placebo in
pediatric patients with excessive daytime sleepiness following cancer therapy.
- Compare the efficacy of half dose methylphenidate hydrochloride and modafinil to
placebo in these patients.
- Assess the effects of these regimens on daytime sleepiness as measured by the Pediatric
Daytime Sleepiness Scale or the Cleveland Adolescent Sleepiness Questionnaire.
- Assess the effects of somnolence symptoms on fatigue as measured by the PedsQL
Multidimensional Fatigue Scale.
- Assess the effects of somnolence symptoms on the quality of life as measured by the
PedsQL Quality of Life Inventory 4.0.
- Determine the incidence of side effects associated with these regimens.
- Determine the prevalence of sleep complaints as measured by the Pediatric Sleep
OUTLINE: This is a multicenter study. Patients are stratified according to age (8-10 years
vs 11-12 years vs 13-17 years vs 18-25 years). Patients are randomized to 1 of 3 treatment
- Arm I: Patients receive oral methylphenidate hydrochloride extended-release once daily
for 7-42 days in the absence of unacceptable toxicity.
- Arm II: Patients receive oral modafinil once daily for 7-42 days in the absence of
- Arm III: Patients receive oral placebo once daily for 7-42 days in the absence of
Patients or their parents complete age-specific sleep and quality-of-life questionnaires at
baseline and after completion of treatment. Patients or their parents complete daily sleep
diaries during the study to collect information about the date, type of day (school,
weekend, or vacation), hours of sleep, anytime the actigraph was removed during the day,
time the child went to bed, and time the child got out of bed in the morning. Patients are
also instructed to wear an actigraph on their non-dominant wrist for 1 week before starting
treatment and during the first and last week of treatment (3 weeks total) to assess
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Average daytime napping minutes in a week as measured by actigraphy
Gerald Rosen, MD
Children's Hospitals and Clinics of Minnesota - St. Paul
United States: Data and Safety Monitoring Board