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Medication Treatment of ADHD in Pediatric Epilepsy

NCT07594652 — Phase 4, Recruiting, 25 participants, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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Use of JornayPM® to Treat ADHD in Pediatric Epilepsy

RegistryNCT07594652
StatusRecruiting
PhasePhase 4
Study typeInterventional; na, single group, masking: none, treatment
Enrollment25 (Estimated)
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc. (Other)
ConditionsADHD - Attention Deficit Disorder With Hyperactivity
Interventionsmethylphenidate hydrochloride (Jornay PM) (Drug)
Datesstart 2026-05-29, primary completion 2030-12-01 (estimated), completion 2030-12-01 (estimated), first posted 2026-05-19, last updated 2026-07-29
Locations1 site in United States

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-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
interventional armExperimentalDrug: methylphenidate hydrochloride (Jornay PM)open label flexible dose
  • methylphenidate hydrochloride (Jornay PM) (Drug): all participants will receive active treatment

+Outcome measures

Primary outcomes

  • Clinical Global Impression-Improvement [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"

+Eligibility

Sex: All, ages: 6 Years to 17 Years

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

+Locations (1)

FacilityCityCountryStatus
Kennedy Krieger InstituteBaltimore, MarylandUnited StatesRecruiting

+Investigators

  • Jay Salpekar, MD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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