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

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.

Butera, Ambra et al.·Frontiers in neurology·2025·Preliminary EvidenceRetrospective Cohort
RTHC-06137Retrospective CohortPreliminary Evidence2025RETHINKTHC RESEARCH DATABASErethinkthc.com/research

Quick Facts

Study Type
Retrospective Cohort
Evidence
Preliminary Evidence
Sample
N=15

What This Study 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.

Key Numbers

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 They Did This

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.

Why This Research 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 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.

What This Study Doesn't 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

Questions This Raises

  • ?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?

Trust & Context

Key Stat:
11 of 15 children showed seizure reduction with CBD, including 2 who became seizure-free
Evidence Grade:
Very small retrospective case series without controls; provides real-world data but cannot establish efficacy beyond existing approved indications
Study Age:
Published 2025
Original Title:
Efficacy and safety of cannabidiol in a single-center pediatric drug-resistant epilepsy cohort: a retrospective study.
Published In:
Frontiers in neurology, 16, 1616480 (2025)
Database ID:
RTHC-06137

Evidence Hierarchy

Meta-Analysis / Systematic Review
Randomized Controlled Trial
Cohort / Case-ControlFollows or compares groups over time
This study
Cross-Sectional / Observational
Case Report / Animal Study

Looks back at existing records to find patterns.

What do these levels mean? →

Frequently Asked 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 More on RethinkTHC

Cite This Study

RTHC-06137·https://rethinkthc.com/research/RTHC-06137

APA

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

MLA

Butera, Ambra, et al. "Efficacy and safety of cannabidiol in a single-center pediatric drug-resistant epilepsy cohort: a retrospective study.." Frontiers in neurology, 2025. https://doi.org/10.3389/fneur.2025.1616480

RethinkTHC

RethinkTHC Research Database. "Efficacy and safety of cannabidiol in a single-center pediat..." RTHC-06137. Retrieved from https://rethinkthc.com/research/butera-2025-efficacy-and-safety-of

Access the Original Study

Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.

This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.