Medication Treatment of ADHD in Pediatric Epilepsy

Q: Who can participate in NCT07594652?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07594652?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

USE of JORNAY PM® to TREAT ADHD in PEDIATRIC EPILEPSY

Medication Treatment of ADHD in Pediatric Epilepsy (NCT07594652) is a Phase 4 interventional studying ADHD - Attention Deficit Disorder With Hyperactivity, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 25 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Who May Qualify: - 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 willing to sign a consent form and fully capable of monitoring the subject's disease process and compliance with treatment. Who Should NOT Join This Trial: - • 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

methylphenidate hydrochloride (Jornay PM)

all participants will receive active treatment

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Kennedy Krieger Institute

Baltimore, Maryland, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07594652), the sponsor (Hugo W. Moser Research Institute at Kennedy Krieger, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07594652 clinical trial studying?

This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07594652?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07594652?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07594652. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07594652. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.