Abstracts

Rationale: Parents of children who have treatment-resistant epilepsy (TRE) typically explore any options available for seizure control.  Many AEDs are associated with side effects, including mood lability, temper outbursts, and other behavioral issues.  Medications may also exacerbate already existing behavioral issues.  Several research studies have focused on using cannabidiol in treatment of children with epilepsy, given reports of improved seizure control and anecdotal reports of improved behavior.  This study focused on examining potential changes in behavior among children with epilepsy who were treated with Epidiolex^® oral solution, a marijuana-based, pharmaceutical formulation of highly purified cannabidiol, as part of a larger research study examining the efficacy of Epidiolex on seizure control.   Methods: 22 pediatric patients with TRE were included in the study.  Behavioral functioning was assessed via parent/caregiver reports using the following questionnaires: Vineland Adaptive Behavior Scales-II (Vineland-II) , Child Behavior Checklist (CBCL), and Conners 3/Conners Parent Rating Scale - Long (CPRL) questionnaires.  Parents completed questionnaires at baseline, prior to their children starting Epidiolex, and again 12 months later.  17 of 22 participants completed the study.  Patients ranged in age from 1 to 17 years.  Means scores from questionnaire indices at baseline and reassessment 12 months later were compared.  Results: No significant changes were seen on any indices including: internalizing behaviors, externalizing behaviors (Vineland-II, CBCL); aggressive behavior, Conduct Disorder behaviors, Oppositional Defiant Disorder behaviors (CBCL, Conners); or mood or anxiety symptoms (CBCL Conclusions: Despite the lack of significant findings between baseline and reassessment, it should be noted that no signs of significant increases in behavioral issues were identified, which is encouraging.  These preliminary findings suggest stable behavioral functioning in children being treated with Epidiolex for treatment of TRE.  To that end, Epidiolex does not appear to result in increases in behavioral issues or seem to exacerbate existing behavioral difficulties.   Funding: Study funded by Greenwich Biosciences/GW Pharmaceuticals