RecruitingPhase 4NCT07594652

Medication Treatment of ADHD in Pediatric Epilepsy

USE of JORNAY PM® to TREAT ADHD in PEDIATRIC EPILEPSY

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Enrollment

25 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.

Min Age: 6 YearsMax Age: 17 Years

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.

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