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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


Phase 2
8 Years
18 Years
Not Enrolling
Both
Central Nervous System Tumor, Pediatric, Fatigue, Specific Disorders of Sleep

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Trial Information

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


OBJECTIVES:

Primary

- Compare the efficacy of methylphenidate hydrochloride and modafinil to placebo in
pediatric patients with excessive daytime sleepiness following cancer therapy.

Secondary

- 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
Questionnaire. (Exploratory)

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
arms.

- 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
unacceptable toxicity.

- Arm III: Patients receive oral placebo once daily for 7-42 days in the absence of
unacceptable toxicity.

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
sleep-wake patterns.

Inclusion Criteria


INCLUSION CRITERIA:

- 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 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

EXCLUSION CRITERIA:

- 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
day).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Average daytime napping minutes in a week as measured by actigraphy

Outcome Time Frame:

29 days

Safety Issue:

No

Principal Investigator

Gerald Rosen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospitals and Clinics of Minnesota - St. Paul

Authority:

United States: Data and Safety Monitoring Board

Study ID:

SCUSF 0803

NCT ID:

NCT01348607

Start Date:

July 2010

Completion Date:

Related Keywords:

  • Central Nervous System Tumor, Pediatric
  • Fatigue
  • Specific Disorders of Sleep
  • psychosocial effects of cancer and its treatment
  • sleep disorders
  • fatigue
  • childhood craniopharyngioma
  • Fatigue
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

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