Recruiting

Observational Study

Sponsor:

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

Code:

NCT07594652

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

methylphenidate hydrochloride (Jornay PM)

Study Details

Brief summary:

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

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

Study ID

NCT07594652

Start date

May 29, 2026

Status verified date

May, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: interventional arm

open label flexible dose

Interventions

methylphenidate hydrochloride (Jornay PM)

all participants will receive active treatment

Primary outcome measure

  • Clinical Global Impression-Improvement [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Neuropsychiatry Study Coordinator

443-923-7612ertenu@kennedykrieger.org

Locations

Kennedy Krieger Institute

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Jay Salpekar, MD

443-923-7600salpekar@kennedykrieger.org

More Information

Sponsor

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

Last update posted

Jul 29, 2026

Last verified

May, 2026

Keywords

  • ADHD
  • epilepsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. on 2026-07-29.