Central Nervous System Tumor, PediatricPhase 2NCT01348607
Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy
A Phase 2 study testing methylphenidate hydrochloride and modafinil in people with Central Nervous System Tumor, Pediatric and Fatigue, run by University of South Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Central Nervous System Tumor, Pediatric, Fatigue, Specific Disorders of Sleep
- What is being tested?
- methylphenidate hydrochloride and modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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).
About this study
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
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.
Read the 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.
- Being tested
- methylphenidate hydrochloride, modafinil, placebo
- Keywords
- psychosocial effects of cancer and its treatment, sleep disorders, fatigue, childhood craniopharyngioma
- Medical subject headings
- Central Nervous System Neoplasms, Fatigue, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidate hydrochlorideDrug
Also called methylphenidate HCl, Concerta
Given orally
modafinilDrug
Also called Provigil
Given orally
placeboDrug
Also called potato starch placebo, placebo capsule
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I - methylphenidate hydrochloride | Experimental | Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity. Receives: Drug: methylphenidate hydrochloride |
| Arm II -modafinil | Experimental | Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity. Receives: Drug: modafinil |
| Arm III placebo | Placebo comparator | Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daytime Napping Minutes in a Week
Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries
Measured: 29 days
Secondary outcomes (1)
Adverse Events
Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startJul 2010
- Primary completionNov 2012
- Study completionDec 2012
Why it stopped: Study only randomized 1 subject and was determined not feasible by DSMB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Central Nervous System Tumor, PediatricStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gerald Rosen, MD, Study chair, Children's Hospitals and Clinics of Minnesota - St. PaulTom Geller, MD, Study chair, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348607
- Sponsor's protocol ID
- SCUSF 0803
- Other IDs
- SCUSF-0803, 5U10CA081920-11
- Status last verified
- Jan 2014
- First submitted
- 4 May 2011
- Last updated
- 21 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01348607
- Acronym / sponsor ID
- SCUSF 0803
- Keywords
- psychosocial effects of cancer and its treatment, sleep disorders, fatigue, childhood craniopharyngioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study only randomized 1 subject and was determined not feasible by DSMB
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Posted 19 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I - methylphenidate hydrochloride | Experimental | Drug: methylphenidate hydrochloridePatients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity. |
| Arm II -modafinil | Experimental | Drug: modafinilPatients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity. |
| Arm III placebo | Placebo comparator | Drug: placeboPatients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidate hydrochlorideAlso: methylphenidate HCl, ConcertaGiven orally | Drug | Arm I - methylphenidate hydrochloride |
| modafinilAlso: ProvigilGiven orally | Drug | Arm II -modafinil |
| placeboAlso: potato starch placebo, placebo capsuleGiven orally | Drug | Arm III placebo |
Primary outcome
Average Daytime Napping Minutes in a Week
Time frame: 29 days
Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries
1 secondary outcome
Adverse Events
Time frame: 29 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Rosen, MD study chair
Children's Hospitals and Clinics of Minnesota - St. Paul
Tom Geller, MD study chair
St. Louis University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing methylphenidate hydrochloride and modafinil in people with Central Nervous System Tumor, Pediatric and Fatigue, run by University of South Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Daytime Napping Minutes in a Week (time frame: 29 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2014.