OpenAvailable NowTreatment Study
Medication Treatment of ADHD in Pediatric Epilepsy
For Condition: ADHD - Attention Deficit Disorder With Hyperactivity
ID: NCT07594652
Horizon Patient Guidance Summary
Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:
How it’s taken
Diet & Lifestyle / Therapy Care
Expected Availability Horizon
Available Now (Approved)
StageApproved Treatment: Already FDA approved and actively prescribed in clinics. This study collects post-market real-world safety metrics.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
Study Timeline & Quick Facts
Trial Status
Open — Looking for Participants
Total Target Enrollment
25 patients (Estimated)
Study Start Date
2026-05-29
Est. Primary Completion
2030-12
Tested Drugs & Treatment Groups
DRUGmethylphenidate hydrochloride (Jornay PM)
all participants will receive active treatment
Treatment Arms Description
EXPERIMENTALinterventional arm
open label flexible dose
Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
Between 6 Years and 17 Years
Full Criteria Checklist
Who Can Join
- 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.
Who Cannot Join
- • 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 is this Study Measuring?
Primary Outcome Measures
- Clinical Global Impression-Improvement — Time Frame: 12 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"
Where to Participate
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
Kennedy Krieger Institute
Baltimore, Maryland, United States
Status: Open
Trial Design & Scientific Setup
Allocation
na
Intervention Model
single group
Primary Purpose
treatment
Masking
none
Sponsoring Teams & Contacts
Lead Sponsoring Institution
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Primary Research Contact
Clinical Trial Application Copilot
Want to apply or inquire about joining this study? Fill out this simple questionnaire, and our assistant will instantly generate a professional email draft you can copy and send to the central contact coordinator listed above!
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Subject: Inquiry about clinical trial enrollment: NCT07594652 - Medication Treatment of ADHD in Pediatric Epilepsy
Dear Study Coordinator / Research Team,
I hope this message finds you well.
My name is [Your Name], and I am writing to express my strong interest in participating in the clinical trial titled "Medication Treatment of ADHD in Pediatric Epilepsy" (NCT ID: NCT07594652).
I am [Age] years old and have been diagnosed with ADHD - Attention Deficit Disorder With Hyperactivity. I have reviewed the eligibility criteria for this study on Med Code Info and believe I may be a suitable candidate.
Could you please let me know if this study is actively enrolling patients at any site near my location, and what the next steps are to undergo screening?
Thank you for your time and research efforts.
Warm regards,
[Your Name]
View Official Medical/Scientific Title
Use of JornayPM® to Treat ADHD in Pediatric Epilepsy