Medication Treatment of ADHD in Pediatric Epilepsy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-17
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
About this trial
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
• 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.
Trial design
Design model
Single group
Treatments tested in this trial
methylphenidate hydrochloride (Jornay PM)
Drugall participants will receive active treatment
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: interventional armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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"
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov