Medication Treatment of ADHD in Pediatric Epilepsy (NCT07594652) | Clinical Trial Compass
RecruitingPhase 4
Medication Treatment of ADHD in Pediatric Epilepsy
United States25 participantsStarted 2026-05-29
Plain-language summary
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inclusion criteria:
* Established diagnosis of epilepsy that requires treatment with anti-seizure medication.
* No episodes of seizure clusters or status epilepticus within 30 days prior to entry into the study.
* Diagnosis of ADHD with functional impairment.
* Good general health as determined by medical history and physical examination, including stable vital signs.
* Participant or legal caregiver capable of providing informed consent and fully capable of monitoring the subject's disease process and compliance with treatment.
Exclusion Criteria:
* • Previous allergic or hypersensitivity reactions to stimulant medicines including Jornay PM®
* Active substance abuse or dependence within 30 days of enrollment
* Epilepsy that is unstable or with seizure frequency that exceeds four events per month, based on an average over the previous three months
* DSM-V diagnosis of psychotic illness or imminent risk of harm to self or others.
* Current use of stimulants to treat ADHD
* Serious or unstable medical or neurologic conditions such as HIV, liver or kidney disease, cancer or diabetes.
* Unstable cardiac illness such as arrythmias or cardiomyopathy.
* Participation in a previous experimental drug study within 30 days of baseline visit.
* Estimated IQ\<70 as indicated by clinical assessment to the degree that rating scales may be invalid
* Insufficient capacity of caregiver or legal guardian to understand and appropriately cons…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for children who have both ADHD and epilepsy — does my child's specific type of epilepsy and ADHD presentation make them a realistic candidate to discuss with the research team?
2Since this is a Phase 4 trial, the medications being tested have already been approved, but I want to understand — what does it mean that they're still studying these ADHD medications in kids with epilepsy specifically, and are there known risks of ADHD medications affecting seizure control that I should know about?
3The main thing this trial is measuring is something called the Clinical Global Impression-Improvement scale — can you explain what that means in practice, and whether an improvement on that scale would translate to a meaningful difference in my child's daily life at school and home?
4If my child joined this trial, how would their epilepsy treatment be monitored alongside the ADHD medication, and who would be responsible for managing both conditions during the study?
5Before considering this trial, should my child try a standard approved ADHD treatment first, or is there a reason that starting with this research study might be worth discussing as an option right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Global Impression-Improvement
Timeframe: 12 weeks
Trial details
NCT IDNCT07594652
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.