Cannabidiol as an Adjuvant Treatment in Adult Patients with Focal Drug Resistant Epilepsy Experience in a Public Hospital. Buenos Aires, Argentina
Abstract number :
3.419
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2022
Submission ID :
2233014
Source :
www.aesnet.org
Presentation date :
12/5/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:29 AM
Authors :
Alejandro Nasimbera, – ENYS - Hospital El Cruce - UNAJ - CONICET; Anilu Daza Restrepo, MD – Fellowship in epilepsy, Neurology, Hospital el cruce; Manuela Villanueva, Fellowship – Hospital el Cruce; Silvia Gonzalez, Fellowship in Epilepsy – Hospital el Cruce; Ines Mintz, Fellowship in neuropsychology – Hospital el Cruce; Patricia Solis, Neuropsychologist – Hospital el Cruce; Juan Pablo Princich, Neuroradiologist – Hospital el Cruce; Julian Lamonarca, Psychiatrist – Hospital el Cruce; Brenda Giagante, Neurologist – Hospital el Cruce; Oddo Silvia, Neurologist – Hospital el Crcue; Silvia Kochen, Head of neurosciences department – Hospital el Cruce
This is a Late-Breaking abstract.
Rationale: To determine the effective dose, level of effectiveness, and tolerability of purified cannabidiol in a public hospital in Argentina as adjuvant treatment for patients with focal drug-resistant epilepsy.
Methods: An open prospective study was performed. We included 58 patients with focal drug-resistant epilepsy, non-surgical, with functional levels of writing and reading comprehension. All patients started cannabidiol treatment with a 100% CBD oil formula (RSHO-XTM Medical Marijuana Inc. San Diego, California, U.S., THC-free) at 250 mg/day (mean: 4.1 mg/kg/day), titration progressively up to 20mg/kg/day according to clinical response and tolerability. The criterion used to assess efficacy was the monthly percentage change in the number of seizures. Tolerability was evaluated through the adverse effects registry.
Results: A total of 58 patients started the trial, 9 of them dropped out (6 because of no effectiveness, 3 with mild side effects), and 2 were excluded due to noncompliance with the protocol. The results are from a partial analysis (44 patients) since there are still 3 patients under evaluation. 84% of the patients (37) reduced 50% of their monthly seizures, of which 2 (4.5%) are free of seizures and 15 patients (34%) decreased more than 80%. The remaining 7 (16%) show a decrease of less than 50% of their usual seizure frequency. The mean final dose was 335 mg/d (5 mg/kg/d), and 329 (4.7 mg/kg/d) in responders (50% seizure reduction). 15p (34%) reported no side effects. The remaining 66% (twenty-nine patients) had mild symptoms. Most of the patients presented only 1 type of side effect (41%), while the minority presented 2 (11%) and 3 types (14%). 60% of the patients who reported side effects were gastrointestinal, 16% had drowsiness, and 14% decreased appetite.
Conclusions: Adults and focal epilepsy are two variables that are underrepresented in the trials of CBD, so far there is little literature describing the dose of CBD in the adult population with focal epilepsy. The average dose in patients who reduced their seizure frequency by 50% was 329 mg/d (4.7 mg/kg/d). Adjuvant treatment with purified CBD in focal epilepsy is effective in 84% of cases and safe in all cases with 329 mg per day
Funding: None
Anti-seizure Medications