Skip to content
Triangle logo TriangleGet started
← Study library

NCT01348607 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2014-02-21

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Average Daytime Napping Minutes in a Week

→

outcome · POSTED

Adverse Events

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility 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 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).
healthy Volunteers
false
maximum Age
18 Years
minimum Age
8 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
    intervention Names
    1. Drug: methylphenidate hydrochloride
    label
    Arm I - methylphenidate hydrochloride
    type
    EXPERIMENTAL
  2. description
    Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
    intervention Names
    1. Drug: modafinil
    label
    Arm II -modafinil
    type
    EXPERIMENTAL
  3. description
    Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
    intervention Names
    1. Drug: placebo
    label
    Arm III placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I - methylphenidate hydrochloride
    description
    Given orally
    name
    methylphenidate hydrochloride
    other Names
    1. methylphenidate HCl
    2. Concerta
    type
    DRUG
  2. arm Group Labels
    1. Arm II -modafinil
    description
    Given orally
    name
    modafinil
    other Names
    1. Provigil
    type
    DRUG
  3. arm Group Labels
    1. Arm III placebo
    description
    Given orally
    name
    placebo
    other Names
    1. potato starch placebo
    2. placebo capsule
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
TRIPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
1
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries
    measure
    Average Daytime Napping Minutes in a Week
    time Frame
    29 days
secondary Outcomes
  1. description
    Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver.
    measure
    Adverse Events
    time Frame
    29 days
Full study description
brief Summary
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.
detailed Description
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-5a88357aa1b6e574cac0
      requested nct id
      NCT01348607
      primary nct id
      NCT01348607
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      ce89f6cff4f448886bc872f2af397ed2016e4c5e39c48bb8256df9ca8386e101
      payload sha256
      a83b770e0236ed1f07a90ff9c484554f19d78c04cd64dab8e4e34e577d58ef55
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-5a88357aa1b6e574cac0
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01348607
      occurrences
      1. context exact
        NCT01348607
        end
        11
        exact text
        NCT01348607
        start
        0
      offset unit
      unicode_code_points
      query cond
      Childhood Craniopharyngioma
      query disease state id
      ds-craniopharyngioma-pediatric
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-craniopharyngioma-000.json
      source file sha256
      ce89f6cff4f448886bc872f2af397ed2016e4c5e39c48bb8256df9ca8386e101
      source json pointer
      /studies/0/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      63d1acd99253c9a40facafa6d70d15bf47f80c0b7b6df0e3e18d00cab3e8884a

    Preserved source evidence · Not medical advice