Study register · detailKlinische Studie · Epilepsy · 2023
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
Navarro et al.·Neurological SciencesImpact 1.9
Clear benefitGRADELow17 citations
Samplen = 44 Pat.
Duration12 weeks, follow-up over at…
EndpointSeizure reduction >50%
Blindingoffen
DesignKlinische Studie
Cannabinoidkombination
THC:CBD1:52.6
Max. dose204.0 mg
Routeoromukosal
”Key finding
79,5% of patients achieved a seizure reduction >50% after 12 weeks; seizure frequency decreased from a median of 11/month to 2,5/month (p<0,001).
Summary
Open-label cohort on CBD-rich magistral formulation (100 mg/ml CBD, THC <1,9 mg/ml) as add-on in adults with treatment-refractory focal epilepsy; n=44, median CBD dose 200 mg/day (3,7 mg/kg), THC 4 mg/day. Median seizure frequency before treatment 11/month, after 12 weeks 2,5/month (p<0,001); 79,5% of patients achieved >50% seizure reduction. Median percentage reduction 84,1%. Five patients reported adverse effects.
P
PopulationAdults with drug-resistant focal epilepsy (DRFE) on stable AED treatment, n=44
I
InterventionCannabis-based magistral formulation (CBMF): 100 mg/ml CBD + THC <1,9 mg/ml, 0,1 ml sublingual every 12 h, weekly titration, median daily dose 200 mg CBD / 4 mg THC
O
OutcomeSeizure frequency reduction >50% in 79,5% of patients after 12 weeks; median seizure count decreased from 11 to 2,5/month (p<0,001); median percentage reduction 84,1%
Confidence in the evidence
Very lowLowModerateHigh
Low
The second of four GRADE levels, the effect estimate is of limited reliability.
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.