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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)

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Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

Locations

Kennedy Krieger Institute

Baltimore, Maryland 21205

United States