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Study breakdown

CBD Reduced Seizures in 11 of 15 Children With Drug-Resistant Epilepsy

Retrospective CohortPreliminary evidence
The takeaway

In a small cohort of 15 children with drug-resistant epilepsy, CBD add-on therapy reduced seizure frequency in 11 patients (7 responders, 4 partial responders), with 2 becoming seizure-free and 11 showing improved social participation.

Pediatric neurologists, parents of children with drug-resistant epilepsy, epilepsy researchers

11 of 15 children showed seizure reduction with CBD, including 2 who became seizure-free

What the researchers found

11 of 15 patients showed seizure frequency reduction: 7 were responders (over 50% reduction, including 2 seizure-free) and 4 were partial responders (30-50% reduction). 11 of 15 also showed improved social and environmental participation. CBD was used on-label in 8 patients (Dravet, Lennox-Gastaut, Tuberous Sclerosis) and off-label in 7.

Why it matters

About 30% of pediatric epilepsy patients do not respond to conventional antiseizure medications. While CBD is approved for three specific syndromes, this real-world study suggests it may benefit a wider range of drug-resistant epilepsies, including off-label uses.

The numbers in context

15 patients; mean age 12.3 years; average CBD dose 16.5 mg/kg/day; 7 responders (>50% reduction), 4 partial responders (30-50%); 2 seizure-free; 11/15 improved social participation; 8 on-label, 7 off-label; good safety profile; structural brain abnormalities in 5/15; cortical malformations in 6/15 (4/6 responded)

How the study worked

Retrospective single-center study of 15 pediatric patients (7 female, 8 male, mean age 12.3 years) with drug-resistant epilepsy who received CBD as adjunctive therapy for at least 6 months. Average dose 16.5 mg/kg/day (max 21 mg/kg/day). Clinical, demographic, and imaging data extracted from records.

What this study cannot tell us

Very small sample (15 patients), retrospective design, single center, no control group, cannot separate CBD effects from placebo or natural disease course, heterogeneous epilepsy types

How to read the evidence

Very small retrospective case series without controls; provides real-world data but cannot establish efficacy beyond existing approved indications

When this study was published

Published 2025

The bigger picture

The finding that patients with cortical malformations responded well to CBD (4 of 6, including 1 seizure-free) is particularly interesting, as these structural abnormalities often predict poor response to conventional medications.

Questions still open

  • Why did patients with cortical malformations respond particularly well? Would larger prospective studies confirm the off-label benefit? What predicts who will respond to CBD adjunctive therapy?

Common questions

Can CBD help children whose seizures do not respond to regular medications?
In this small study, 11 of 15 children with drug-resistant epilepsy showed seizure reduction with CBD add-on therapy, including 2 who became seizure-free. Seven of the 15 received CBD off-label (beyond its three approved conditions).
Were there side effects from CBD in these children?
CBD showed a good safety and tolerability profile in this cohort. The average dose was 16.5 mg/kg/day, and the treatment was well-tolerated over at least 6 months.

Read the original research

Efficacy and safety of cannabidiol in a single-center pediatric drug-resistant epilepsy cohort: a retrospective study.

Frontiers in neurology, 16, 1616480

Citation

Butera, Ambra; Spoto, Giulia; Ceraolo, Graziana; Grella, Maria; Giunta, Ivana; Albertini, Maria Ludovica; Consoli, Carla; Sferro, Caterina; Spanò, Maria; Di Rosa, Gabriella; Nicotera, Antonio Gennaro. (2025). Efficacy and safety of cannabidiol in a single-center pediatric drug-resistant epilepsy cohort: a retrospective study.. Frontiers in neurology, 16, 1616480. https://doi.org/10.3389/fneur.2025.1616480

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