Canna~Fangled Abstracts

Cannabis-based magistral formulation is highly effective as an adjuvant treatment in drug-resistant focal epilepsy in adult patients: an open-label prospective cohort study

By September 21, 2022No Comments

. 2022 Sep 21.

doi: 10.1007/s10072-022-06393-1.

Online ahead of print.
Cristian Eduardo Navarro 1 2 3 4
Affiliations 

Abstract

Introduction: The safety and efficacy of a formulation high in cannabidiol (CBD) and low in ∆9-tetrahydrocannabinol (THC) to treat drug-resistant epilepsy have been examined previously in children, but not in adult population. The aim of this study was to evaluate whether CBD-rich oil, as an add-on treatment to conventional antiepileptic drugs, was effective, safe, and well-tolerated in adults with drug-resistant focal epilepsy (DRFE).

Methods: An open-label, prospective cohort, single-center in adult patients with DRFE, were receiving stable doses of antiepileptic drugs (AEDs). A cannabis based-magistral formulation (CBMF) (100 mg/ml CBD and THC <1.9 mg/ml) was administrated 0.1 ml sublingually every 12 hours, up-titrated weekly. The primary outcome was to establish a reduction in seizures frequency >50% at 12 weeks. Adverse-drug reactions monitoring was done. p-value <0.05 was statistically significant.

Results: Between August 2020 and July 2022, 44 (38.6%) patients completed >3 months of follow-up. The median daily dose of CBD was 200 mg, that of THC was 4 mg, and that of CBD per kilogram of weight was 3.7 mg. The median number of seizures per month before CBD treatment was 11, and after CBD treatment was 2.5 (p<0.001). A reduction in seizures >50% at 12 week was achieved in 79.5% of the patients. The median percentage change in seizure frequency per month was 84.1% at 12 weeks. Five patients reported any adverse-drug reactions.

Conclusion: The CBMF is a highly effective and safety therapy to treat adult patients with DRFE. The reduction in seizures frequency is maintained over time.

Keywords: Cannabidiol, Cannabis, Drug-resistant epilepsy, Epilepsies partial, Treatment outcome

References

    1. Devinsky O, Cross JH, Laux L et al (2017) Trial of cannabidiol for drug-resistant seizures in the Dravet syndrome. N Engl J Med 376:2011–2020. https://doi.org/10.1056/NEJMoa1611618 – DOI – PubMed
    1. Devinsky O, Patel AD, Thiele EA et al (2018) Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome. Neurology 90:e1204–e1211. https://doi.org/10.1212/WNL.0000000000005254 – DOI – PubMed – PMC
    1. Devinsky O, Patel AD, Cross JH et al (2018) Effect of cannabidiol on drop seizures in the Lennox-Gastaut syndrome. N Engl J Med 378:1888–1897. https://doi.org/10.1056/NEJMoa1714631 – DOI – PubMed
    1. Thiele EA, Marsh ED, French JA et al (2018) Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 391:1085–1096. https://doi.org/10.1016/S0140-6736(18)30136-3 – DOI – PubMed
    1. Thiele EA, Bebin EM, Bhathal H et al (2021) Add-on cannabidiol treatment for drug-resistant seizures in tuberous sclerosis complex. JAMA Neurol 78:285. https://doi.org/10.1001/jamaneurol.2020.4607 – DOI – PubMed

Leave a Reply