๐ฌIn plain words
What the trial is, and whether it could suit you
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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:
* โข Previous allergic or hypersensitivity reactions to stimulant medicines including Jornay PMยฎ
* 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
๐
What it tests
- methylphenidate hydrochloride (Jornay PM)
Kennedy Krieger Institute
Baltimore, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.