CBD Reduced Seizures by 45-87% Over Nearly Three Years in Treatment-Resistant Focal Epilepsy

In the Expanded Access Program, 140 patients with treatment-resistant focal epilepsies experienced sustained seizure reductions of 45-87% through 144 weeks of CBD treatment, with similar outcomes for TSC and non-TSC patients.

Patel, Anup D et al.·Epilepsia·2025·Moderate EvidenceProspective Cohort
RTHC-07321Prospective CohortModerate Evidence2025RETHINKTHC RESEARCH DATABASErethinkthc.com/research

Quick Facts

Study Type
Prospective Cohort
Evidence
Moderate Evidence
Sample
N=140

What This Study Found

CBD treatment was associated with median reductions of 51-87% in focal seizures and 44-87% in total seizures in the TSC group, and 46-75% and 45-71% in the non-TSC group, sustained through 144 weeks. Responder rates were similar between groups. Adverse events occurred in 91% of TSC and 96% of non-TSC patients. Median CBD dose was about 23-25 mg/kg/day.

Key Numbers

N=140 patients. 33 TSC (median age 11.9, range 2-31), 107 non-TSC (median age 17.8, range 2-73). Non-TSC subtypes: cortical dysplasia 14%, frontal lobe 10%, cortical malformation 9%. CBD dose: TSC 25 mg/kg/day, non-TSC 23 mg/kg/day. Seizure reduction sustained through 144 weeks. AEs: 91% TSC, 96% non-TSC.

How They Did This

Open-label expanded access program following 140 patients with treatment-resistant focal epilepsies (33 with TSC, 107 with other focal epilepsies) receiving plant-derived CBD (Epidiolex) at doses up to 25-50 mg/kg/day for up to 144 weeks.

Why This Research Matters

While CBD (Epidiolex) is FDA-approved for certain epilepsy syndromes including TSC, its effectiveness in non-TSC focal epilepsies has been less documented. This study shows sustained long-term benefit across multiple types of focal epilepsy, potentially expanding the clinical applications of CBD.

The Bigger Picture

This long-term data strengthens the case for CBD as a treatment option beyond its currently approved epilepsy indications. The similar effectiveness across different focal epilepsy types suggests the anticonvulsant mechanism may be broadly applicable rather than specific to certain epilepsy syndromes.

What This Study Doesn't Tell Us

Open-label study without placebo control, so the magnitude of benefit may be overestimated. Expanded access population may have different characteristics than typical patients. High adverse event rates, though many AEs may be related to concomitant medications. Dropout over 144 weeks may create survivorship bias.

Questions This Raises

  • ?Would randomized controlled trials confirm these results in non-TSC focal epilepsies?
  • ?What is the optimal long-term dose?
  • ?How does CBD compare to or complement other anti-seizure medications for focal epilepsies?
  • ?What drives the high adverse event rate?

Trust & Context

Key Stat:
45-87% seizure reduction sustained through 144 weeks of CBD treatment
Evidence Grade:
Moderate evidence from a long-term open-label expanded access program with a reasonable sample size, though limited by the lack of placebo control.
Study Age:
2025 analysis of long-term data from the CBD Expanded Access Program.
Original Title:
Long-term efficacy and safety of cannabidiol in patients with treatment-resistant focal epilepsies treated in the Expanded Access Program.
Published In:
Epilepsia, 66(10), 3730-3740 (2025)
Database ID:
RTHC-07321

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

Enrolls participants and follows them forward in time.

What do these levels mean? →

Frequently Asked Questions

Does CBD work for focal epilepsy?

In this open-label study, 140 patients with treatment-resistant focal epilepsies experienced seizure reductions of 45-87% that were sustained for nearly three years. Benefits were similar whether the epilepsy was caused by tuberous sclerosis or other focal epilepsy types.

What dose of CBD was used?

Patients received plant-derived CBD (Epidiolex) starting at 2-10 mg/kg/day, titrated up to each patient's limit or maximum of 25-50 mg/kg/day. The median daily dose was about 23-25 mg/kg/day.

Read More on RethinkTHC

Cite This Study

RTHC-07321·https://rethinkthc.com/research/RTHC-07321

APA

Patel, Anup D; Szaflarski, Jerzy P; Lyons, Paul D; Boffa, Michael; Greco, Teresa; Saurer, Timothy B; Rajasekaran, Karthik; Simontacchi, Kelly C; Thiele, Elizabeth A. (2025). Long-term efficacy and safety of cannabidiol in patients with treatment-resistant focal epilepsies treated in the Expanded Access Program.. Epilepsia, 66(10), 3730-3740. https://doi.org/10.1111/epi.18496

MLA

Patel, Anup D, et al. "Long-term efficacy and safety of cannabidiol in patients with treatment-resistant focal epilepsies treated in the Expanded Access Program.." Epilepsia, 2025. https://doi.org/10.1111/epi.18496

RethinkTHC

RethinkTHC Research Database. "Long-term efficacy and safety of cannabidiol in patients wit..." RTHC-07321. Retrieved from https://rethinkthc.com/research/patel-2025-longterm-efficacy-and-safety

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.