Spanish expanded access program showed CBD reduced seizures by 48% in treatment-resistant epilepsy
In a Spanish expanded access program of 102 patients with severe epilepsy, purified CBD reduced total monthly seizures by 47.6%, with 44.9% achieving at least 50% seizure reduction at 6 months.
Quick Facts
What This Study Found
44.9% of patients had at least 50% seizure reduction at 6 months, 38.9% at 12 months. Median total seizures per month reduced by 47.6% from baseline to last visit. Seizure severity decreased in 61.1% at 12 months. Quality of life improved 21.2%. Adverse events in 66.7%, most commonly somnolence (34.3%).
Key Numbers
102 patients. Mean age 15.9. Mean 7.5 prior failed ASMs. Mean CBD dose 13.0 mg/kg/day. Seizure reduction at 6 months: 44.9% had 50%+ reduction. Median seizure reduction: 47.6%. Quality of life improved 21.2%. Somnolence 34.3%, diarrhea 12.7%. Discontinuation for AEs alone: 7.8%.
How They Did This
Multicenter retrospective observational study of 102 patients (mean age 15.9, 59% LGS, 12% Dravet, 29% other syndromes) treated with purified CBD at 14 Spanish hospitals. Highly refractory population with mean 7.5 previously failed anti-seizure medications.
Why This Research Matters
This real-world expanded access data complements clinical trial results by showing how CBD performs in a broader, highly refractory patient population in routine clinical practice.
The Bigger Picture
Expanded access programs provide valuable data on medications before or alongside formal approval, reaching patients who cannot wait for or access clinical trials.
What This Study Doesn't Tell Us
Retrospective, uncontrolled design. No placebo comparison. Self/caregiver-reported seizure counts. Heterogeneous patient population. Selection bias from expanded access enrollment.
Questions This Raises
- ?Would the other 29% of epilepsy syndromes (non-DS, non-LGS) respond as well in controlled trials?
- ?Is the 13 mg/kg/day dose optimal?
- ?Why does response rate decrease slightly from 6 to 12 months?
Trust & Context
- Key Stat:
- 47.6% median seizure reduction in patients who failed 7.5 prior medications
- Evidence Grade:
- Moderate: multicenter real-world data from 102 patients, but retrospective and uncontrolled.
- Study Age:
- Published in 2022.
- Original Title:
- Outcomes from a Spanish Expanded Access Program on cannabidiol treatment in pediatric and adult patients with epilepsy.
- Published In:
- Epilepsy & behavior : E&B, 137(Pt A), 108958 (2022)
- Authors:
- Villanueva, Vicente(2), García-Ron, Adrián, Smeyers, Patricia, Arias, Eva, Soto, Victor, García-Peñas, Juan José, González-Alguacil, Elena, Sayas, Débora, Serrano-Castro, Pedro, Garces, Mercedes, Hampel, Kevin, Tomás, Miguel, Lara, Julian, de Toledo, María, Barceló, Ines, Aledo-Serrano, Angel, Gil-Nagel, Antonio, Iacampo, Lucas, Falip, Mercè, Saiz-Diaz, Rosa Ana, Gómez-Ibañez, Asier, Sopelana, David, Sanchez-Larsen, Alvaro, López-González, Francisco Javier
- Database ID:
- RTHC-04278
Evidence Hierarchy
Looks back at existing records to find patterns.
What do these levels mean? →Frequently Asked Questions
How treatment-resistant were these patients?
Very. The average patient had tried and failed 7.5 different anti-seizure medications before receiving CBD, making any seizure reduction clinically meaningful.
Did quality of life improve?
Yes. Quality of life scores improved by 21.2% from baseline to last visit, based on the CAVE scale.
What were the main side effects?
Somnolence (34.3%) and diarrhea (12.7%) were most common. Adverse events occurred in 66.7% but only 7.8% discontinued solely due to side effects.
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Cite This Study
https://rethinkthc.com/research/RTHC-04278APA
Villanueva, Vicente; García-Ron, Adrián; Smeyers, Patricia; Arias, Eva; Soto, Victor; García-Peñas, Juan José; González-Alguacil, Elena; Sayas, Débora; Serrano-Castro, Pedro; Garces, Mercedes; Hampel, Kevin; Tomás, Miguel; Lara, Julian; de Toledo, María; Barceló, Ines; Aledo-Serrano, Angel; Gil-Nagel, Antonio; Iacampo, Lucas; Falip, Mercè; Saiz-Diaz, Rosa Ana; Gómez-Ibañez, Asier; Sopelana, David; Sanchez-Larsen, Alvaro; López-González, Francisco Javier. (2022). Outcomes from a Spanish Expanded Access Program on cannabidiol treatment in pediatric and adult patients with epilepsy.. Epilepsy & behavior : E&B, 137(Pt A), 108958. https://doi.org/10.1016/j.yebeh.2022.108958
MLA
Villanueva, Vicente, et al. "Outcomes from a Spanish Expanded Access Program on cannabidiol treatment in pediatric and adult patients with epilepsy.." Epilepsy & behavior : E&B, 2022. https://doi.org/10.1016/j.yebeh.2022.108958
RethinkTHC
RethinkTHC Research Database. "Outcomes from a Spanish Expanded Access Program on cannabidi..." RTHC-04278. Retrieved from https://rethinkthc.com/research/villanueva-2022-outcomes-from-a-spanish
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.