ADHD - Attention Deficit Disorder With HyperactivityChildren's healthDrugPhase 4
What this study is
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
What's being tested
- methylphenidate hydrochloride (Jornay PM)
Intervention · DRUG
all participants will receive active treatment
Study details
- Official title
- USE of JORNAY PM® to TREAT ADHD in PEDIATRIC EPILEPSY
- Sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Conditions
- ADHD - Attention Deficit Disorder With Hyperactivity
- Enrolling
- 25 people
- Starts
- 2026-05
- Est. completion
- 2030-12
- Design
- Open-label, single group, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Years – 17 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openKennedy Krieger Institute
Baltimore, Maryland, United States
- Jay Salpekar, MD · Contact443-923-7600salpekar@kennedykrieger.org
Recruiting
Study team
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study ID 526503
Principal investigator
Jay Salpekar, MD
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.