ALL, ChildhoodNCT01100658
Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors
A study testing Methylphenidate in people with ALL, Childhood and Leukemia, Lymphoblastic, run by University of Minnesota at 1 site in United States.
Trial summary
While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- ALL, Childhood, Leukemia, Lymphoblastic, Leukemia, Lymphoblastic, Acute
- What is being tested?
- Methylphenidate
- 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
- 1 siteUnited States
- Study dates
- May 2010to Nov 2010
- Phase
- Interventional
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Initial Screening and Registration
- Previous diagnosis of acute lymphoblastic leukemia or brain tumor and have been off treatment and in disease-free remission for a minimum of one year; treated at the University of Minnesota Medical Center, Fairview.
- Proficient in English
- Have given informed consent (assent)
- After Initial Screening
- Have evidence of attention impairment based on parent report of attention deficit (> and = 75% on attention deficit hyperactivity disorder [ADHD] Index, Hyperactivity, or Cognitive-Problems/Inattention Index of parent-completed attention deficit hyperactivity disorder (ADHD) rating scale [Conners Parent Rating Scale] and perform at least 1.0 standard deviations below the mean on Omissions, Commissions, or Variability indexes of the Test of Variables of Attention (TOVA)
- Have an estimated Full Scale IQ score on the Wechsler Abbreviated Scale of Intelligence (WASI) >55.
Who cannot join
- Have optic pathway gliomas and/or neurofibromatosis
- Diagnosed with ADD/ADHD prior to their cancer diagnosis
- Currently taking antidepressants or antipsychotics
- Currently being treated with stimulant medication
- Blind
- Have glaucoma
Show all 10Show fewer
- Have a family or personal history of motor or phonic tics or Tourette syndrome
- Have seizures not controlled by antiepileptic drugs
- Taking an MAO-inhibitor
- Have a history of cardiovascular disease, uncontrolled hypertension, or hyperthyroidism, or current hypertension requiring antihypertensives
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
About this study
Official title: Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer
While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate in the treatment of children with attention deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for improving attention and behavioral functioning in children with medical illnesses or brain injury are less clear.
Patients will be randomized to receive one week of Metadate CD (a controlled release form of methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.
- Conditions
- ALL, Childhood, Leukemia, Lymphoblastic, Leukemia, Lymphoblastic, Acute, Leukemia, Lymphoblastic, Acute, L1, Leukemia, Lymphoblastic, Acute, L2, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
- Being tested
- Methylphenidate, Placebo
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Metadae CD (TM), Methylphenidate hydrochloride
1 capsule each day for 1 week, .3 mg/kg dose.
PlaceboDrug
Also called Inactive substance
1 capsule per day for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Active comparator | Administered 1 capsule each day for 1 week, .3 mg/kg dose. Receives: Drug: Methylphenidate |
| Placebo | Placebo comparator | Administered 1 capsule each day for 1 week. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Methylphenidate on Neurocognitive Components
Child performance on neuropsychological testing (i.e., using Test of Variables of Attention [TOVA] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder [ADHD], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores < or = 1 SD below the mean represent area of deficit.
Measured: Week 1 and Week 2
Secondary outcomes (1)
Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior
Parent and teacher ratings of attention, executive function and behavior (i.e., Behavior Rating Inventory of Executive Function [BRIEF -a parent questionnaire and a teacher questionnaire-designed to assess executive functioning in home and school environments. Conners Parent Rating Scale-3 Short Form [CPRS-3 research and clinical tool for obtaining parental reports of childhood behavior problems.] Standard scores average = 50 + or - 10. Higher scores indicate more severe difficulty. Scores > or = 60 represent areas of significant behavior concern.
Measured: Week 1 and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Due to slow accrual
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 ALL, ChildhoodStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Cancer Research Fund
- Responsible party
- Sponsor
- Investigators
- Alicia Kunin-Batson, Ph.D., Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100658
- Sponsor's protocol ID
- 2009NTLS075
- Other IDs
- 0907M69644
- Status last verified
- Mar 2015
- First submitted
- 7 Apr 2010
- Last updated
- 27 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer
- ClinicalTrials.gov ID
- NCT01100658
- Acronym / sponsor ID
- 2009NTLS075
- Conditions
- ALL, Childhood, Leukemia, Lymphoblastic, Leukemia, Lymphoblastic, Acute, Leukemia, Lymphoblastic, Acute, L1, Leukemia, Lymphoblastic, Acute, L2, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Children's Cancer Research Fund
- Study start
- May 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Posted 22 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate in the treatment of children with attention deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for improving attention and behavioral functioning in children with medical illnesses or brain injury are less clear.
Patients will be randomized to receive one week of Metadate CD (a controlled release form of methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Active comparator | Drug: MethylphenidateAdministered 1 capsule each day for 1 week, .3 mg/kg dose. |
| Placebo | Placebo comparator | Drug: PlaceboAdministered 1 capsule each day for 1 week. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Initial Screening and Registration
- Previous diagnosis of acute lymphoblastic leukemia or brain tumor and have been off treatment and in disease-free remission for a minimum of one year; treated at the University of Minnesota Medical Center, Fairview.
- Proficient in English
- Have given informed consent (assent)
- After Initial Screening
Key exclusion criteria (10 listed)
- Have optic pathway gliomas and/or neurofibromatosis
- Diagnosed with ADD/ADHD prior to their cancer diagnosis
- Currently taking antidepressants or antipsychotics
- Currently being treated with stimulant medication
- Blind
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 |
|---|---|---|
| MethylphenidateAlso: Metadae CD (TM), Methylphenidate hydrochloride1 capsule each day for 1 week, .3 mg/kg dose. | Drug | Methylphenidate |
| PlaceboAlso: Inactive substance1 capsule per day for 1 week. | Drug | Placebo |
Primary outcome
Effectiveness of Methylphenidate on Neurocognitive Components
Time frame: Week 1 and Week 2
Child performance on neuropsychological testing (i.e., using Test of Variables of Attention [TOVA] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder [ADHD], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores < or = 1 SD below the mean represent area of deficit.
1 secondary outcome
Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior
Time frame: Week 1 and Week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- 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.
Alicia Kunin-Batson, Ph.D. principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylphenidate in people with ALL, Childhood and Leukemia, Lymphoblastic, run by University of Minnesota at 1 site in United States.
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 7 inclusion and 10 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 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2011). 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?
Effectiveness of Methylphenidate on Neurocognitive Components (time frame: Week 1 and Week 2). 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 27 Mar 2015.