Actively Recruiting
Use of Jornay PM to Treat ADHD in Pediatric Epilepsy
Led by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Updated on 2026-05-19
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of stimulant medication, specifically methylphenidate hydrochloride (Jornay PM), for treating Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents with epilepsy. This observational study focuses on understanding how this medication is used in pediatric patients who have both epilepsy and ADHD, assessing its effects in this specific group. The study is sponsored by the Hugo W. Moser Research Institute at Kennedy Krieger, Inc. and is categorized as a Phase 4 trial. All participants in the study will receive open-label, flexible doses of the active drug, Jornay PM, which is a stimulant medication. The medication will be administered under medical supervision throughout the study period, with dosing adjusted as needed. This study does not include a placebo or comparator group, as all enrolled children will receive treatment. The trial spans from May 2026 to December 2030. Participants, aged 6 to 17 years with diagnosed epilepsy and ADHD, will be monitored for 12 weeks to evaluate treatment impact using the Clinical Global Impression-Improvement scale. Study involvement includes regular assessments of health status, seizure activity, and ADHD symptoms. Caregivers will provide consent and assist in monitoring adherence and disease progression. Safety and treatment effects will be observed throughout the trial duration.
CONDITIONS
Brief Title
Medication Treatment of ADHD in Pediatric Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of epilepsy requiring anti-seizure medication
- No seizure clusters or status epilepticus within 30 days before study entry
- Diagnosis of ADHD with functional impairment
- Good general health with stable vital signs
- Participant or caregiver able to give informed consent and monitor treatment compliance
You will not qualify if you...
- Allergy or hypersensitivity to stimulant medicines including Jornay PM
- Active substance abuse or dependence within 30 days of enrollment
- Unstable epilepsy or more than four seizures per month on average over past three months
- Diagnosis of psychotic illness or risk of harm to self or others
- Current use of stimulant medications for ADHD
- Serious or unstable medical or neurological conditions (e.g., HIV, liver/kidney disease, cancer, diabetes)
- Unstable cardiac illness such as arrhythmias or cardiomyopathy
- Participation in previous experimental drug study within 30 days of baseline
- Estimated IQ below 70 affecting rating scale validity
- Caregiver unable to understand or consent for study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive methylphenidate hydrochloride (Jornay PM) as active treatment for ADHD in pediatric epilepsy.
Trial Site Locations
Total: 1 location
1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
N
Neuropsychiatry Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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