Abstracts

Rationale: Cannabidiol (CBD) is a non-psychoactive plant-derived cannabinoid that has been shown to be effective for the treatment of drug resistant epilepsy. Epidiolex is the first FDA approved purified CBD, which is an adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome (DS) and Tuberous Sclerosis (TSC). Anxiety may affect up to 50% of children with epilepsy, and may negatively impact quality of life. CBD has been shown to reduce anxiety symptoms in adults; however, the effects of CBD on anxiety in children remain unknown. In this ongoing study, we examine the effect of Epidiolex on seizure reduction and on the improvement of anxiety symptoms in pediatric epilepsy patients._x000D_
Methods: We conducted a preliminary analysis (n=8; ages 2-20; 5 female, 3 male) of our ongoing 4-6-week observational study of pediatric epilepsy patients. Participants were enrolled prior to initiation on CBD (Epidiolex, Jazz Pharmaceuticals) for clinically indicated seizures. Parents or guardians completed a baseline survey about their child before starting on CBD, and completed weekly follow up until achieving the maintenance dose (4-6 weeks; ~10-25 mg/kg). Surveys collected data regarding seizure frequency, medication side effects, anxiety symptoms, and other behavioral problems. Electroencephalography (EEG) was used to assess baseline epileptic waveforms. Brain MRI and genetic test findings also were collected. Paired samples t-tests were used for the comparison of baseline and end treatment survey characteristics.

Results: All subjects had medically uncontrolled focal and generalized seizures with generalized and multifocal epileptiform discharges on the EEG. Five cases had underlying genetic conditions; three had structural brain abnormalities. Six cases had only motor seizures; one each had non-motor seizure alone and mixed type of seizures (Table 1). EEG findings showed multifocal epileptiform discharges and two had 3-5 Hz interictal generalized epileptiform discharges while the remaining had slow generalized spike and wave discharges. Seven out of 8 cases reported a reduction in seizure frequency from baseline to the end of the study (p=0.005). Fewer average negative side effects were seen in the majority (p=0.033). Reduction in child’s anxiety symptoms from baseline to the end of the study was seen in the majority, and this reduction reached statistical significance (p=0.015) (Table 2).

Conclusions: These data are consistent with prior studies demonstrating the effectiveness of CBD in reducing seizures. CBD may have tolerable side effects profile. Although preliminary, these data also suggest that CBD may be a promising approach for reducing anxiety symptoms. This notion will be explored in future studies.

Funding: Supported by a grant from the Children’s Foundation (Co-PIs: AL and HM)