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Nighttime ADHD drug tested in kids with epilepsy

NCT ID NCT07594652

Symptom relief Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This study tests whether Jornay PM, a stimulant taken at night for ADHD, is safe and helpful for children who also have epilepsy. About 25 kids will take the medication and be monitored for improvements in ADHD symptoms. The goal is to ease attention and hyperactivity without triggering seizures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methylphenidate hydrochloride (Jornay PM)
What this could lead to
If it works, this could offer a safe way to treat ADHD symptoms in children with epilepsy, improving focus and behavior.
What could go wrong
This is a small, early-phase study with only 25 participants. It may not show clear benefits, and stimulants can sometimes increase seizure risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADHD - attention deficit disorder with hyperactivity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kennedy Krieger Institute

    RECRUITING

    Baltimore, Maryland, 21205, United States

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