Medication Treatment of ADHD in Pediatric Epilepsy
Purpose
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
Condition
- ADHD - Attention Deficit Disorder With Hyperactivity
Eligibility
- Eligible Ages
- Between 6 Years and 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- observational
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- open label, flexible dose
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental interventional arm |
open label flexible dose |
|
Recruiting Locations
Kennedy Krieger Institute
Baltimore, Maryland 21205
Baltimore, Maryland 21205
More Details
- Status
- Recruiting
- Sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.