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RecruitingNCT07594652Updated Jul 29, 2026

Medication Treatment of ADHD in Pediatric Epilepsy

A Phase 4 interventional study of methylphenidate hydrochloride (Jornay PM) in ADHD - Attention Deficit Disorder With Hyperactivity, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. Recruiting at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
6 Years to 17 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • ADHD - Attention Deficit Disorder With Hyperactivity

Keywords

  • ADHD
  • epilepsy
03

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    interventional arm

    open label flexible dose

    Drug: methylphenidate hydrochloride (Jornay PM)

Interventions

  • Drugmethylphenidate hydrochloride (Jornay PM)

    all participants will receive active treatment

05

What researchers measure

Primary outcomes

  1. Clinical Global Impression-Improvement

    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"

    Time frame: 12 weeks

06

Study locations

1 of 1 sites recruiting
  • Kennedy Krieger Institute
    Baltimore, Maryland 21205, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — This is a small dataset so will not share IPD in order to preserve confidentiality.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07594652
Lead sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Responsible party
Jay Salpekar, M.D. (Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.) — Principal investigator
First posted
May 19, 2026
Start date
May 29, 2026
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Jul 29, 2026

Study contacts

Neuropsychiatry Study Coordinator
Contact
ertenu@kennedykrieger.org
443-923-7612
Jay Salpekar, MD
principal investigator · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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