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

This study has been terminated.
(Study only randomized 1 subject and was determined not feasible by DSMB)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01348607
First received: May 4, 2011
Last updated: January 23, 2014
Last verified: January 2014

May 4, 2011
January 23, 2014
July 2010
November 2012   (final data collection date for primary outcome measure)
Average Daytime Napping Minutes in a Week [ Time Frame: 29 days ] [ Designated as safety issue: No ]
Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries
Average daytime napping minutes in a week as measured by actigraphy [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01348607 on ClinicalTrials.gov Archive Site
Adverse Events [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver.
  • Improvement in symptoms associated with excessive daytime sleepiness as measured by the Cleveland Adolescent Sleepiness Questionnaire or Pediatric Daytime Sleepiness Scale [ Designated as safety issue: No ]
  • Change in the average daily napping minutes from baseline to days 8-14 [ Designated as safety issue: No ]
  • Quality of life as measured by the PedsQL Quality of Life Inventory 4.0 [ Designated as safety issue: No ]
  • Fatigue as measured by the PedsQL Multidimensional Fatigue Scale [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
  • Central Nervous System Tumor, Pediatric
  • Fatigue
  • Specific Disorders of Sleep
  • Drug: methylphenidate hydrochloride
    Given orally
    Other Names:
    • methylphenidate HCl
    • Concerta
  • Drug: modafinil
    Given orally
    Other Name: Provigil
  • Drug: placebo
    Given orally
    Other Names:
    • potato starch placebo
    • placebo capsule
  • Experimental: Arm I - methylphenidate hydrochloride
    Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
    Intervention: Drug: methylphenidate hydrochloride
  • Experimental: Arm II -modafinil
    Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
    Intervention: Drug: modafinil
  • Placebo Comparator: Arm III placebo
    Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
December 2012
November 2012   (final data collection date for primary outcome measure)

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 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

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).
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01348607
SCUSF 0803, SCUSF-0803, 5U10CA081920-11
Yes
University of South Florida
University of South Florida
National Cancer Institute (NCI)
Study Chair: Gerald Rosen, MD Children's Hospitals and Clinics of Minnesota - St. Paul
Study Chair: Tom Geller, MD St. Louis University
University of South Florida
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP