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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

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
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

In context

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

This study's planned enrollment of 25 is below the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc. is the lead sponsor of 76 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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 and fully capable of monitoring the subject's disease process and compliance with treatment.

Exclusion Criteria:

    • Previous allergic or 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
      • 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 , 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

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

06

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

07

Study locations

1 of 1 sites recruiting
08

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Dec 2030, 55 months after the start.

Of 44 non-industry phase 4 interventional studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 81. This study's planned 55 months is close to that.

Counting every sponsor, half of 62 studies reached it within 38 months; a quarter within 18 and three quarters within 70.

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2026
First posted
May 19, 2026
StartActual
May 29, 2026
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2030
Last update
Jul 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Studies of the drug tested here: Methylphenidate

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Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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