Prescription CBD Without Clobazam Reduced Seizures in 30% of Lennox-Gastaut Patients at 12 Months
In a real-world European study, plant-derived CBD (Epidyolex) used without the commonly co-prescribed drug clobazam achieved a 50%+ seizure reduction in 30% of Lennox-Gastaut patients and 13% of Dravet patients at 12 months, with good retention and tolerability.
Quick Facts
What This Study Found
Among 107 patients (92 LGS, 15 DS) receiving CBD without clobazam for at least 3 months, median seizure frequency change ranged from -6.2% to -20.9% for LGS and 0% to -16.7% for DS over 3-month intervals. At 12 months, 30% of LGS and 13% of DS patients achieved 50%+ seizure reduction. Retention on CBD without clobazam was 63% at 12 months. Adverse events occurred in 31%, mostly somnolence, seizure, diarrhea, and decreased appetite.
Key Numbers
107 patients (92 LGS, 15 DS). Mean CBD dose: 13.54 mg/kg/day (LGS), 11.56 mg/kg/day (DS). 50%+ seizure reduction at 12 months: 30% LGS, 13% DS. 12-month retention: 63%. Adverse events: 31%. Four patients had elevated liver enzymes.
How They Did This
Retrospective chart review of patients aged 2+ with LGS or DS enrolled in a European Early Access Program for plant-derived CBD (Epidyolex). Data covered 3 months before through 12 months after CBD initiation. Only patients not taking clobazam were included.
Why This Research Matters
Most clinical trials of CBD for epilepsy included clobazam, raising questions about whether CBD works independently. This real-world study provides evidence that CBD without clobazam still provides meaningful seizure reduction for some patients with severe epilepsy syndromes.
The Bigger Picture
CBD has been approved for LGS and DS primarily based on trials where many patients also took clobazam. Because clobazam and CBD interact (CBD raises clobazam levels), there has been debate about how much of the benefit comes from CBD alone. This study, while uncontrolled, helps fill that gap.
What This Study Doesn't Tell Us
No placebo control or randomization. Retrospective chart review with potential for incomplete documentation. Small DS subgroup (n = 15). Open-label design introduces expectation bias. Mean CBD dose was below the upper end of the approved dose range.
Questions This Raises
- ?Would higher CBD doses without clobazam produce better seizure control?
- ?Why is the response rate lower in Dravet syndrome than Lennox-Gastaut when CBD is used without clobazam?
Trust & Context
- Key Stat:
- 30% of LGS patients achieved 50%+ seizure reduction with CBD alone at 12 months
- Evidence Grade:
- Real-world chart review from a structured access program, providing practical effectiveness data but lacking placebo control.
- Study Age:
- Published 2023, data from European Early Access Program.
- Original Title:
- Retrospective chart review study of use of cannabidiol (CBD) independent of concomitant clobazam use in patients with Lennox-Gastaut syndrome or Dravet syndrome.
- Published In:
- Seizure, 110, 78-85 (2023)
- Authors:
- Nabbout, Rima(4), Arzimanoglou, Alexis, Auvin, Stéphane(2), Berquin, Patrick, Desurkar, Archana, Fuller, Douglas, Nortvedt, Charlotte, Pulitano, Patrizia, Rosati, Anna, Soto, Victor, Villanueva, Vicente, Cross, J Helen
- Database ID:
- RTHC-04805
Evidence Hierarchy
Looks back at existing records to find patterns.
What do these levels mean? →Frequently Asked Questions
Does CBD work for seizures without clobazam?
This study suggests it can. About 30% of Lennox-Gastaut patients achieved meaningful seizure reduction with CBD alone at 12 months, and 63% stayed on it for a full year.
What side effects were seen?
Adverse events occurred in 31% of patients, most commonly somnolence, seizure recurrence, diarrhea, and decreased appetite. Four patients had elevated liver enzymes.
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Cite This Study
https://rethinkthc.com/research/RTHC-04805APA
Nabbout, Rima; Arzimanoglou, Alexis; Auvin, Stéphane; Berquin, Patrick; Desurkar, Archana; Fuller, Douglas; Nortvedt, Charlotte; Pulitano, Patrizia; Rosati, Anna; Soto, Victor; Villanueva, Vicente; Cross, J Helen. (2023). Retrospective chart review study of use of cannabidiol (CBD) independent of concomitant clobazam use in patients with Lennox-Gastaut syndrome or Dravet syndrome.. Seizure, 110, 78-85. https://doi.org/10.1016/j.seizure.2023.05.003
MLA
Nabbout, Rima, et al. "Retrospective chart review study of use of cannabidiol (CBD) independent of concomitant clobazam use in patients with Lennox-Gastaut syndrome or Dravet syndrome.." Seizure, 2023. https://doi.org/10.1016/j.seizure.2023.05.003
RethinkTHC
RethinkTHC Research Database. "Retrospective chart review study of use of cannabidiol (CBD)..." RTHC-04805. Retrieved from https://rethinkthc.com/research/nabbout-2023-retrospective-chart-review-study
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.