ADHD - Attention Deficit Disorder With HyperactivityPhase 4NCT07594652
Medication Treatment of ADHD in Pediatric Epilepsy
A Phase 4 study testing methylphenidate hydrochloride (Jornay PM) in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ADHD - Attention Deficit Disorder With Hyperactivity
- What is being tested?
- methylphenidate hydrochloride (Jornay PM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2026to Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- • 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Jay Salpekar, MD, 443-923-7600, salpekar@kennedykrieger.org
About this study
Official title: Use of JornayPM® to Treat ADHD in Pediatric Epilepsy
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
- Being tested
- methylphenidate hydrochloride (Jornay PM)
- Keywords
- ADHD, epilepsy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidate hydrochloride (Jornay PM)Drug
all participants will receive active treatment
| Study group | Role | What they receive |
|---|---|---|
| interventional arm | Experimental | open label flexible dose Receives: Drug: methylphenidate hydrochloride (Jornay PM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start29 May 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD - Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- observational
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Salpekar, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Jay Salpekar, MD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594652
- Sponsor's protocol ID
- 526503
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small dataset so will not share IPD in order to preserve confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of JornayPM® to Treat ADHD in Pediatric Epilepsy
- ClinicalTrials.gov ID
- NCT07594652
- Acronym / sponsor ID
- 526503
- Keywords
- ADHD, epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Study start
- 29 May 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- observational
| Arm | Type | Receives |
|---|---|---|
| interventional arm | Experimental | Drug: methylphenidate hydrochloride (Jornay PM)open label flexible dose |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
Key exclusion criteria (10 listed)
- • Previous allergic or hypersensitivity reactions to stimulant medicines including Jornay PM®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidate hydrochloride (Jornay PM)all participants will receive active treatment | Drug | interventional arm |
Primary outcome
Clinical Global Impression-Improvement
Time frame: 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"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No. This is a small dataset so will not share IPD in order to preserve confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jay Salpekar, MD principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methylphenidate hydrochloride (Jornay PM) in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neuropsychiatry Study Coordinator (443-923-7612, ertenu@kennedykrieger.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression-Improvement (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.