Efficacy of Cannabidiol Oral Solution in Idiopathic Generalized Epilepsy with Typical Absence Seizures
Abstract number :
3.29
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2022
Submission ID :
2204026
Source :
www.aesnet.org
Presentation date :
12/5/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:23 AM
Authors :
Marina Azevedo, BS – University of South Florida; Catherine Passariello, PhD – Medical Science Liaison, Neurology, Greenwich Biosciences; Nikolina Katusa, PharmD – Clinical Research Associate, Neurology- Epilepsy, University of South Florida; David Rose, MD – Neurology – University of South Florida; Stephanie MacIver, MD – Medical Doctor, Assistant Professor, Neurology- Epilepsy, University of South Florida; Ushtar Amin, MD – Medical Doctor, Assistant Professor, Neurology- Epilepsy, University of South Florida; Angelica Rivera-Cruz, MD – Medical Doctor, Assistant Professor, Neurology- Epilepsy, University of South Florida; Selim Benbadis, MD – Medical Director, Associate Professor, Neurology- Epilepsy, University of South Florida
Rationale: Current treatments for typical absence seizures are limited. Standard of care includes ethosuximide and valproate, while all other anti-seizure medicines (ASMs) have no class 1 evidence of efficacy for this seizure type. Cannabidiol (Epidiolex®, CBD) has been studied in 5 randomized controlled trials evaluating its efficacy in various seizure types (focal and generalized) that are prominent in three specific epilepsy syndromes: Dravet, Lennox-Gastaut, and Tuberous Sclerosis Complex.1 There have been non-controlled open-label studies of other types of epilepsy, reporting improvement in seizure frequency with CBD.2 Thus, CBD may be a broad-spectrum ASM effective in typical absence seizures._x000D_
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Objective: This study seeks to determine if CBD has efficacy in patients with typical absence seizures of idiopathic generalized epilepsy (IGE), using an electroencephalogram (EEG) as an objective measure.
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Methods: We prospectively enrolled subjects 6 years of age and older with IGE and spike wave complexes (SWC) at 2.5-4 Hz on EEG. Inclusion criteria consisted of a diagnosis of IGE with typical absence seizures, and a minimum of 3 discharges lasting > 2 seconds (SWC burden > 6 seconds) on a baseline 24-hour ambulatory EEG. Subjects were stable on their current seizure medication regimen. CBD doses ranged from 5 to 20 mg/kg/day, for 90 days, after which a second 24-hour EEG was performed. The primary outcome was the SWC burden change from pre to post-CBD treatment. The secondary outcome was a subjective measure of overall health perception in the Quality of Life in Epilepsy (QOLIE) questionnaire.
Results: A total of 9 subjects were screened. Five did not meet the minimum SWC burden, and were therefore excluded. Four completed the study. SWC burden increased in 3 subjects and decreased in 1 (Table 1) after the 90-day treatment period. Three out of 4 subjects reported an improvement in the QOLIE score, and 2 out of 4 subjects elected to continue off-label Epidiolex®. Enrollment is ongoing and target is 15 patients.
Conclusions: The effect of CBD on SWC burden was variable (1 subject improved and 3 worsened). However our small sample size makes any conclusions preliminary and hypothesis-generating only. Possible compounding factors include sleep deprivation and medication non-compliance. Paradoxically, some subjects with an objective increase in SWC reported a decrease in generalized tonic-clonic (GTC) and a score improvement of QOLIE, suggesting pleiotropic benefits of CBD.
1. Epidiolex (cannabidiol) [package insert].Carlsbad, CA: Greenwich Biosciences, Inc; 2021._x000D_
2. Devinsky O, Marsh E, Friedman D, et al. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial. Lancet Neurol. 2016;15(3):270-8. doi: 10.1016/S1474-4422(15)00379-8
Funding: Greenwich Biosciences (Jazz Pharmaceuticals)
Anti-seizure Medications