| Prospective, open-label, multicenter, interventional trial |
137 patients (age range, 1–30 years) with childhood-onset treatment-resistant epilepsy |
All types of seizures: 37.0% had a reduction of 50.0% or more.
DS (n=32): median reduction of 42.7% in monthly total seizures for all seizure types and 13.0% were free of all seizure types
LGS (n=32): median reduction of 35.5% in monthly total seizures for all types. |
CBD
25–50mg/kg/day for 12 weeks |
Devinsky et al.1717 Devinsky O, Marsh E, Friedman D, Thiele E, Laux L, Sullivan J, et al. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial. Lancet Neurol. 2016;15:270-8. https://doi.org/10.1016/S1474-4422(15)00379-8
https://doi.org/10.1016/S1474-4422(15)00...
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| Prospective, double-blind, placebo-controlled, multicenter trial |
120 patients (age range, 2–18 years) with DS and drug-resistant seizures |
Adjusted median difference between CBD and placebo: seizure frequency was − 22.8 percentage points (p=0.010).
Percentage of patients who became seizure-free: 5.0% with CBD vs. 0.0% with placebo (p=0.080). |
CBD
20mg/kg/day for 14 weeks |
Devinsky et al.1818 Devinsky O, Cross JH, Laux L, Marsh E, Miller I, Nabbout R, et al. Trial of cannabidiol for drug-resistant seizures in the Dravet Syndrome. N Engl J Med. 2017;376:2011-20. https://doi.org/10.1056/NEJMoa1611618
https://doi.org/10.1056/NEJMoa1611618...
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| Prospective, double-blind, placebo-controlled, multicenter trial |
171 patients (age range, 2–55 years) with LGS that not responded to treatment |
Median percent reduction in drop-seizure frequency from baseline: −17.2 (p=0.014) with CBD vs. placebo. |
CBD
20mg/kg/day for 14 weeks |
Thiele et al.1919 Thiele EA, Marsh ED, French JA, Mazurkiewicz MB, Benbadis SR, Joshi C, et al. Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018;391:1085-96. https://doi.org/10.1016/S0140-6736(18)30136-3
https://doi.org/10.1016/S0140-6736(18)30...
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| Prospective, double-blind, placebo-controlled, multicenter trial |
225 patients (age range, 2–55 years) with LGS |
Median percent reduction in drop-seizure frequency: 41.9% in CBD 20mg/kg/day, 37.2% in CBD 10mg/kg/day, and 17.2% in placebo group (p<0.050) |
CBD
10 or 20mg/kg/day for 14 weeks |
Devinsky et al.2020 Devinsky O, Patel AD, Cross JH, Villanueva V, Wirrell EC, Privitera M, et al. Effect of cannabidiol on drop seizures in the Lennox–Gastaut Syndrome. N Engl J Med. 2018;378:1888-97. https://doi.org/10.1056/NEJMoa1714631
https://doi.org/10.1056/NEJMoa1714631...
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| Prospective, double-blind, placebo-controlled, multicenter trial |
224 patients (age range, 1–65 years; 166 between 1 and 17) with TSC medication-resistant epilepsy |
Percentage reduction in total seizures: 29.1% (p=0.001) for CBD 25mg/kg/day vs. placebo. 28.4% (p=0.002) for CBD 50mg/kg/day vs. placebo |
CBD
25 or 50mg/kg/day for 14 weeks |
Thiele et al.2121 Thiele EA, Bebin EM, Bhathal H, Jansen FE, Kotulska K, Lawson JA, et al. Add-on cannabidiol treatment for drug-resistant seizures in tuberous sclerosis complex: a placebo-controlled randomized clinical trial. JAMA Neurol. 2021;78:285-92. https://doi.org/10.1001/jamaneurol.2020.4607
https://doi.org/10.1001/jamaneurol.2020....
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