Medication Treatment of ADHD in Pediatric Epilepsy

NCT07594652 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 526503
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

Keywords

ADHD; epilepsy

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression-Improvement

  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"

  12 weeks

Study Arms (1)

interventional arm

EXPERIMENTAL

open label flexible dose

Drug: methylphenidate hydrochloride (Jornay PM)

Interventions

methylphenidate hydrochloride (Jornay PM) DRUG

all participants will receive active treatment

interventional arm

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Epilepsy

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jay Salpekar, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neuropsychiatry Study Coordinator

CONTACT

443-923-7612; ertenu@kennedykrieger.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: open label, flexible dose
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: observational

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)