←Epilepsy
Study register · detail Multizentrische prospektive Studie (open-label) · Epilepsy · 2023

Cannabidiol in children with treatment-resistant epilepsy with myoclonic-atonic seizures.

Caraballo et al. ·Epilepsy & Behavior Impact 2.4
Clear benefit GRADE Moderate 15 citations
Samplen = 26 Pat.
Durationmean follow-up of 19 months
Endpointseizure frequency
Blindingoffen
DesignMultizentrische prospektive Studie (open-label)
Cannabinoidcbd
Routeoral
Key finding

Add-on CBD reduced seizure frequency by more than 50% in over half of the children, with mild side effects.

Summary

Multicenter study (n=26, of which 22 EMAtS + 4 Sturge-Weber syndrome), CBD add-on 8–40 mg/kg/day, mean follow-up 19 months: 15/26 (57.7%) achieved >50% seizure reduction; 3/26 (11.5%) became seizure-free. The remaining 11 patients (42.3%) achieved a 25–50% reduction. Side effects mild, no discontinuation of therapy due to adverse events.

P
PopulationChildren with treatment-resistant epilepsy with myoclonic-atonic seizures (EMAtS) or Sturge-Weber syndrome with myoclonic-atonic seizures, n=26
I
InterventionAdd-on cannabidiol (CBD), 8–40 mg/kg/day, oral
O
Outcome57,7% (15/26) achieved >50% seizure reduction; 11,5% (3/26) became seizure-free; the remaining 42,3% showed 25–50% reduction
Confidence in the evidence
Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for
Imprecision
Quality profile
Sample size ★★★★★
Blinding Open-label
Effect size Clear benefit
Citations / year ★★★★★
Authors
Caraballo RH, Reyes Valenzuela G, Fortini S, Espeche A, Gamboni B, Silva W, Semprino M, Fasulo L, Chacón S, Gallo A, Galicchio S, Cachia P.
DOI 10.1016/j.yebeh.2023.109245↗
Design: Multizentrische prospektive Studie (open-label)
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Abstract
<h4>Purpose</h4>This multicenter study aimed to evaluate the efficacy and tolerability of add-on cannabidiol (CBD) in treatment-resistant patients with epilepsy with myoclonic-atonic seizures (EMAtS) (n = 22) and Sturge Weber syndrome (SWS) with myoclonic-atonic seizures (n = 4).<h4>Methods</h4>Patients who met the diagnostic criteria of treatment-resistant EMAtS or SWS with myoclonic-atonic seizures were included. Cannabidiol was added in doses ranging from 8 to 40 mg/kg/day. Efficacy was assessed by comparing seizure frequency before and after initiating CBD therapy. Neurologic examinations, brain magnetic resonance imaging, repeated prolonged electroencephalography (EEG) and/or video-EEG recordings, and neurometabolic studies were performed in all patients, and genetic investigations in 15.<h4>Results</h4>After a mean follow-up of 19 months, 15/26 patients (57.7%) who received add-on CBD had a >50% seizure decrease; three (11.5%) became seizure-free. The remaining 11 patients (42.3%) had a 25-50% seizure reduction. Drop attacks, including myoclonic-atonic seizures and generalized tonic-clonic seizures, as well as atypical absences and nonconvulsive status epilepticus responded well to CBD. In SWS patients, focal motor seizures without consciousness impairment and focal non-motor seizures with consciousness impairment were recognized in two each; in three a 30% reduction of focal seizures was observed. Side effects were mild and did not lead to CBD discontinuation.<h4>Conclusion</h4>This study evaluating the use of add-on CBD in children with EMAtS or SWS with myoclonic-atonic seizures found that 15/26 (57.7%) had a >50% seizure reduction with good tolerability; three (11.5%) became seizure-free.
Indication
Further studies on Epilepsy
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S Thiele et al. · 2018 · The Lancet
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Phase-III-RCT (GWPCARE4) bei Lennox-Gastaut-Syndrom, n=171 (2–55 Jahre), randomisiert zu CBD 20 mg/kg/d vs. Placebo über 14 Wochen. Primärer Endpunkt: prozentuale Reduktion der monatlichen Drop-Seizure-Frequenz. Multizentrisch (24 Zentren USA, Niederlande, Polen). 14 Patienten in CBD-Gruppe, 1 in Placebo-Gruppe brachen ab. [Numerische Outcomes im Abstract abgeschnitten; Volltext zeigt signifikante Drop-Seizure-Reduktion vs. Placebo].

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The impediment to action advances action. — Marcus Aurelius