Stimulant Medication for ADHD in Children with Epilepsy
Medication Treatment of ADHD in Pediatric Epilepsy
Recruiting
Phase 4Interventional Study
ADHD - Attention Deficit Disorder With Hyperactivity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 – 17
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Other
Who this trial is looking for
This trial is looking for children with ADHD and epilepsy to assess the use of stimulant medication. Participants need to be in good health and have their epilepsy stable.
Are You a Good Fit for This Trial?
Rules you outPsychotic illnessSubstance abuseSevere heart issuesSerious medical conditions
You may be able to join if
I have been diagnosed with epilepsy that requires treatment.
I have ADHD and it affects my daily life.
I have not had any seizures in the last 30 days.
I am in good general health.
I or my caregiver can provide informed consent.
I have stable vital signs.
You may not be able to join if
I have had allergic reactions to stimulant medications.
I have a history of substance abuse in the last 30 days.
My epilepsy is unstable or I have more than four seizures a month.
I have a psychotic illness or I may harm myself or others.
I am currently taking stimulants for ADHD.
I have serious medical conditions like HIV or cancer.
I have unstable heart issues like arrhythmias.
I participated in another drug study in the last 30 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
Trial Locations
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Status
Eligibility Criteria
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 g…
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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