Cannabis-based magistral formulation…

September 26, 2022

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

 

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.

Related Posts

Consistent, convergent pathways link two forms of autism

Consistent, convergent pathways link two forms of autism

Consistent, convergent pathways link two forms of autism BY ANGIE VOYLES ASKHAM  /  15 NOVEMBER 2022 / https://doi.org/10.53053/OWUW9177 The brains of people with a duplication of the 15q11-13 chromosomal region have dysregulated gene expression, particularly in...

Molecular and behavioral consequences of Ube3a gene overdosage in mice

Molecular and behavioral consequences of Ube3a gene overdosage in mice

JCI Insight. 2022 Sep 22; 7(18): e158953. Published online 2022 Sep 22. doi: 10.1172/jci.insight.158953 PMCID: PMC9675564  PMID: 36134658     Molecular and behavioral consequences of Ube3a gene overdosage in mice A. Mattijs Punt,1,2 Matthew C. Judson,3 Michael S....