Medication Treatment of ADHD in Pediatric Epilepsy

USE of JORNAY PM® to TREAT ADHD in PEDIATRIC EPILEPSY

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

Study Overview

• Status: Recruiting
• Conditions: ADHD - Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Drug: methylphenidate hydrochloride (Jornay PM)

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Neuropsychiatry Study Coordinator; Phone Number: 443-923-7612; Email: ertenu@kennedykrieger.org

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Kennedy Krieger Institute
      • Contact: Jay Salpekar, MD; Phone Number: 443-923-7600; Email: salpekar@kennedykrieger.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interventional arm; open label flexible dose	Drug: methylphenidate hydrochloride (Jornay PM); all participants will receive active treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Investigators: Principal Investigator: Jay Salpekar, MD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ADHD; epilepsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Epilepsy; Attention Deficit Disorder with Hyperactivity; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carboxylic Acids; Piperidines; Acids, Carbocyclic; Phenylacetates; Methylphenidate
• Other Study ID Numbers: 526503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small dataset so will not share IPD in order to preserve confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No