NCT07594652PHASE4Recruiting
Medication Treatment of ADHD in Pediatric Epilepsy
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Start Date
5/29/2026
Completion Date
12/1/2030
Summary
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
Eligibility Criteria
Age Range: 6 years to 17 years
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 consent for study procedures
Interventions
DRUG
methylphenidate hydrochloride (Jornay PM)
Conditions
ADHD - Attention Deficit Disorder With Hyperactivity
Locations
Kennedy Krieger Institute
Baltimore, Maryland 21205
United States