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Medication Treatment of ADHD in Pediatric Epilepsy

This study is looking at how well a medication called methylphenidate hydrochloride (Jornay PM) works for children and teenagers with both ADHD (Attention Deficit Hyperactivity Disorder) and epilepsy. All participants will receive this active medication. To join, you must be between 6 and 17 years old, have an established diagnosis of epilepsy that requires treatment, and have ADHD with functional impairment. You also cannot have had seizure clusters or status epilepticus (a long seizure or many seizures close together) within 30 days before starting the study. The main goal is to see how much your ADHD symptoms improve after 12 weeks of treatment, as measured by a doctor's assessment. The study aims to enroll 25 participants, but its current status is unclear.

Study design
This is an observational study where all 25 participants will receive the active treatment, methylphenidate hydrochloride (Jornay PM).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 weeks, indicating follow-up for at least that duration.

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NCT07594652

Medication Treatment of ADHD in Pediatric Epilepsy

Recruiting
PHASE4Ages 6–17InterventionalTreatment
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
~25 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:methylphenidate hydrochloride (Jornay PM)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical Global Impression-Improvement
Measured over 12 weeks

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

Explore related trials

Attention Deficit Hyperactivity DisorderSeizure Disorder

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Jay Salpekar, MD · PRINCIPAL_INVESTIGATOR · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Who to contact

Neuropsychiatry Study Coordinator
[email protected]
443-923-7612
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Eligibility criteria

Inclusion

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

• 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

What this trial measures

  • Clinical Global Impression-Improvement12 weeks

    Clinical Global Impression-Improvement (CGI-I) is a 1-7 point scale to assess improvement. 1 reflects "very much improved" and 7 reflects "very much not improved"