Research Article
Volume 12 Issue 1 - 2020
Efficacy and Tolerability of Add-on Cannabidiol in Pediatric Patients with Drug-Resistant Epilepsy: An Open Exploratory Interventional Study in México
Carlos G Aguirre-Velázquez1*, Kenny Lemus-Roldán1, Jaba Kokhreidze2, Levan Darjania3 and Stuart W Titus3
1Pediatric Neurology, Tecnológico de Monterrey, México
2JKMD Global Medical Solutions, Costa Mesa, CA, USA
3MJNA Group LLC., San Diego, CA, USA
*Corresponding Author: Carlos G Aguirre Velázquez, Pediatric Neurologist, Professor of Pediatric Neurology at Tecnológico de Monterrey Medical School, Monterey, México.
Received: November 20, 2019; Published: December 09, 2019




Abstract

Purpose: To describe the experience of a private neuropediatric clinic on using standardized cannabidiol (CBD) product (RSHO-X™. Medical Marijuana Inc. San Diego, CA, USA), to treat pediatric patients diagnosed with drug-resistant epilepsy (RE) in México.

Methods: Forty-six (46) pediatric patients (age: 1 - 17 years) with severe, drug-resistant epilepsy, who were receiving stable doses of antiepileptic drugs (AED) before study entry. 37 patients were evaluable based on protocol compliance (adherence to treatment and completed control follow-ups at 3, 6, 9 and 12 months). The selected formula contained 5000 mg CBD in 236 mL MCT coconut oil and was free of THC. The initial CBD doses treatment was (1 - 2 mg/kg/day) and progressively titrate the dose up to 5 mg/kg/day during the first 4 weeks to reduce the seizure frequency by 50% or more. The primary efficacy endpoint was the median percentage change in the mean monthly seizure frequency at the end of the study period. The tolerability was evaluated base on the record of the side effects.

Results: The treatment yielded a positive effect on seizure reduction after 3 months. Most of the children 25/37 (67.5%) reported a reduction in seizure frequency; a 100% reduction in 1 (2.2%), more than 80% reduction in 11 (25%), 50% or more in 25 (67.5%) and less than 50% reduction was reported in 12 (27.2%) patients, respectively. Two patients reported an increase in seizures (4.3%), two no improvement (4.3%) and three (6.5%) abandoned with adverse effects dropped out of follow-up before 3 months are not included in this analysis. Adverse reactions occurred in 11/37 (29.7%) patients, with a mild grade in 10 subjects and moderate in 1 subject respectively.

Conclusion: The results of this study on the treatment of CBD (RSHO-X™) oil for drug-resistant epilepsy in children and adolescents are promising with good efficacy and tolerability.

Keywords: Resistant Epilepsy; Seizures; Pediatric Epilepsy; Cannabidiol

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Citation: Carlos G Aguirre Velázquez., et al. “Efficacy and Tolerability of Add-on Cannabidiol in Pediatric Patients with Drug-Resistant Epilepsy: An Open Exploratory Interventional Study in México”. EC Neurology 12.1 (2020): 01-11.

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