Medication treatment for ADHD in children with epilepsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional study focuses on the use of methylphenidate hydrochloride (Jornay PM) to treat ADHD in pediatric patients with epilepsy. Eligible participants have a stable epilepsy diagnosis requiring anti-seizure medication, ADHD with functional impairment, and no recent seizure clusters. The study excludes individuals with stimulant hypersensitivity, recent substance issues, unstable epilepsy, or certain psychiatric risks. Conducted at the Kennedy Krieger Institute, the trial aims to observe outcomes related to ADHD management in this comorbidity context.

Why it matters

Who can join: the full rules

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

Where it's running

• Kennedy Krieger Institute
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Jay Salpekar, MD — Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Study coordinator: Neuropsychiatry Study Coordinator
• Email: ertenu@kennedykrieger.org
• Phone: 443-923-7612

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.