Abstracts

Rationale: Intractable epilepsy substantially reduces quality of life (QOL). Whether or not experimental treatment with cannabidiol (CBD) is associated with changes in QOL remains unclear. The aim of this study was to compare QOL in patients with epilepsy treated with CBD and patients not treated with CBD. We hypothesized that baseline QOLIE-89 scores in the CBD study subjects would not significantly differ from patients with epilepsy not enrolled in the CBD study and that follow-up scores would show improved QOL after being treated with CBD. Methods: As part of the AL state sponsored compassionate use CBD Expanded Access Program, we collected from adult patients' baseline (prior to treatment) and follow-up QOLIE-89 questionnaires. Further, to establish whether these patients have QOL similar to patients with treatment-resistant epilepsy at our center, we also collected QOLIE-89 data from patients with video/EEG confirmed epilepsy who are not participating in the CBD program. The AL state CBD program is an open label safety study in the use of CBD (pharmaceutical grade; Epidiolex) for treatment refractory epilepsy, defined as failing at least 4 anti-epileptic drugs (AEDs), including a trial of 2 concomitant AEDs. Patients in the CBD study completed QOLIE-89 at the time of enrollment and at 1 year or at the time of study completion; other patients completed QOLIE-89 once during EMU admission for pre-surgical evaluation. There were 40 adult subjects who completed baseline QOLIE-89 at the time of CBD study enrollment (mean age 28.9 11.1 years; taking on average 3.0 AEDs; 53% female) and 69 patients with a diagnosis of treatment-resistant epilepsy admitted to the University of Alabama at Birmingham Epilepsy Monitoring Unit between 2013-2014 (mean age 35.712.3 years (p=0.004); taking on average 2.1 AEDs (p < 0.000); 68% female; p=0.113). Of the subjects enrolled in the CBD program, 6 completed baseline and follow-up QOLIE-89 at one year or at study withdrawal. All of the subjects in this analysis withdrew from the study early due to lack of efficacy. Duration of treatment at the time of the follow-up QOLIE-89 varied, including 12 months (n=1), 6 months (n=4), and 3 months (n=1) after beginning treatment with CBD. T-test was used for the comparison between subject groups and Wilcoxon rank sum test was used for analysis of QOLIE-89 scores between baseline and follow-up QOLIE-89 in CBD subjects. Results: A clinically significant change in QOLIE-89 was defined as ?- 10 points, as previously studied. Mean baseline QOLIE-89 score for CBD study subjects was 48.6 18.8 and the mean score for other epilepsy patients was 51.9 20.4 points (p=0.42; clinically a non-significant difference). Mean change in QOLIE-89 score between baseline and follow up questionnaires in the 6 subjects who ultimately withdrew from the CBD study was +10.2 points (p=0.053; clinically significant difference, see Table 1). Conclusions: The QOL in patients enrolled in the AL state CBD program is overall similar to other patients with refractory epilepsy treated at our center. We observed a clinically significant increase in QOL rating associated with CBD treatment in a small sample of patients. Future comparisons will need to include data from subjects who remain on CBD long-term including comparisons between responders and non-responders. Funding: State of Alabama