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New treatment option for Brain Tumor, Pediatric
Official title Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue
ClinicalTrials.gov ID: NCT06905587
What this study is testing
What is Methylphenidate (MPH)?
Methylphenidate (MPH) is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for brain tumor, pediatric.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Cancer-related fatigue is a common and debilitating late effect in pediatric brain tumor survivors. Currently, evidence-based recommendations to ameliorate this condition are lacking.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 27
You may be able to join if
- Diagnosed and treated for a brain tumor during childhood or adolescence (0-≤18 years).
- Treated for a PBT during the previous 10 years, starting from date of diagnosis.
- Aged ≥6 years 0 months at the start of the trial.
- Off therapy/active treatment for pediatric brain tumor (PBT) for 12 months at the start of the trial.
- No known signs of clinical or radiological tumor progression at last follow-up.
You likely can't join if
- Any known contraindications to methylphenidate as outlined below: A) Hypersensitivity to the active substance or any excipients listed in the summary...
- History of recent poorly controlled seizures.
- Motor tics or Tourette syndrome (including family history of tic disorder).
- Known diagnosis of Attention Deficit/Hyperactivity Disorder or Autism Spectrum Disorder.
- Known diagnosis of Full Scale Intelligence Quotient (FSIQ) of \<50.
- Pregnancy. Participants known to be pregnant or breastfeeding at screening/registration will not be enrolled in the trial. All sexually active women...
See the full eligibility criteria
- Diagnosed and treated for a brain tumor during childhood or adolescence (0-≤18 years).
- Treated for a PBT during the previous 10 years, starting from date of diagnosis.
- Aged ≥6 years 0 months at the start of the trial.
- Off therapy/active treatment for pediatric brain tumor (PBT) for 12 months at the start of the trial.
- No known signs of clinical or radiological tumor progression at last follow-up.
- Danish is the sole or primary language (enabling provision of validated assessment tools).
- Patient and family have provided consent for inclusion in the trial.
- Clinically significant fatigue based on the PedsQL MFS questionnaire at baseline, defined by a score ≥ 1 standard deviation below the normative mean.
- History of clinically relevant fatigue after treatment of PBT compared to estimated premorbid ability, as assessed from consultations in the childhood cancer outpatient clinics.
- Any known contraindications to methylphenidate as outlined below: A) Hypersensitivity to the active substance or any excipients listed in the summary of product characteristics. B) Glaucoma. C) Pheochromocytoma. D)...
- History of recent poorly controlled seizures.
- Motor tics or Tourette syndrome (including family history of tic disorder).
- Known diagnosis of Attention Deficit/Hyperactivity Disorder or Autism Spectrum Disorder.
- Known diagnosis of Full Scale Intelligence Quotient (FSIQ) of \<50.
- Pregnancy. Participants known to be pregnant or breastfeeding at screening/registration will not be enrolled in the trial. All sexually active women of childbearing potential (WOCBP) must have a negative pregnancy test...
- Concerns about family ability to safely store or administer MPH, or to report side effects appropriately/concerns about familial substance abuse.
- Concurrent use of opiods (ATC N02A) or benzodiazepines (ATC N05BA and N05CF).
- Simultaneously enrolled in another clinical trial investigating cancer-related fatigue with a pharmaceutical intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Aarhus, Denmark
- Copenhagen, Denmark
- Odense, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 27 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Aarhus, Denmark; Copenhagen, Denmark; Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.