Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy

Not Recruiting

Trial ID: NCT01348607


RATIONALE: Methylphenidate hydrochloride or modafinil may help reduce daytime sleepiness and improve the quality of life of patients with excessive daytime sleepiness after cancer therapy. It is not yet known whether methylphenidate hydrochloride or modafinil are more effective than a placebo in reducing daytime sleepiness in these patients. PURPOSE: This randomized phase II trial is studying methylphenidate hydrochloride or modafinil to see how well they work compared with a placebo in treating young patients with excessive daytime sleepiness after cancer therapy.

Official Title

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

Stanford Investigator(s)

Paul Graham Fisher, MD
Paul Graham Fisher, MD

Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health



   - Patient and family must agree to return to the clinic up to 8 times within 2 months

   - Children ≥ 8 and <18 years of age at the time of study entry who were previously
   treated for:

   - a hypothalamic tumor

   - mid-line brain tumor

   - a tumor involving one or both thalami

   - craniopharyngioma

   - diagnosis of hydrocephalus secondary to a brain tumor or treatment of a brain tumor
   that required placement of a permanent shunt.

   - Off cancer treatment for at least six months

   - Proficient in English

   - Able to swallow capsules

   - Experiencing symptoms of excessive daytime sleepiness (EDS) for at least three months
   prior to study entry that is not a result of inadequate sleep hygiene or other known
   medical disorder.

   - Negative pregnancy test


   - Patients treated with doxorubicin or high dose cyclophosphamide

   - History of a clinically significant drug sensitivity to methylphenidate, modafinil,
   armodafinil or any of their components

   - Known cardiac disorders including arrhythmias, hypertension requiring treatment or
   structural heart disease

   - Have taken methylphenidate or modafinil within the last 14 days

   - Current/concurrent use of antihistamines, benzodiazepine, anticonvulsants or alcohol

   - Clinical diagnosis of major depression, subclinical depression, or anxiety disorder

   - History of psychosis or mania

   - Patients with suicidal ideation

   - Diagnosis with anemia, untreated hypothyroidism, mononucleosis or narcolepsy

   - History of substance abuse

   - Pregnant or breast feeding

   - A total dietary intake of more than 500 mg of caffeine per day (e.g., approximately
   ten 330 mL cans of soft drinks, five cups of coffee or tea, or 750 g chocolate per


drug: methylphenidate hydrochloride

drug: modafinil

drug: placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs

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