NCT07594652 · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Medication Treatment of ADHD in Pediatric Epilepsy
What this study is about
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
View original scientific description
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 consent for study procedures
Where
- Baltimore, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 19, 2026 · Source of record for eligibility and locations