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The phase 3 X-TOLE2 trial evaluated azetukalner, a novel Kv7 potassium channel opener, as adjunctive therapy in adults with focal epilepsy who had ≥4 focal seizures per month despite stable treatment with 1–3 antiseizure medications. A total of 374 participants across 138 sites were treated with placebo (n=125), azetukalner 15 mg (n=125) or azetukalner 25 mg (n=124) once daily for 12 weeks, without titration. Median monthly seizure frequency fell by 34.5% with 15 mg and 53.2% with 25 mg, compared with 10.4% with placebo (both P<0.001). The ≥50% responder rate was 37.6% (OR 2.41, 95% CI 1.35–4.33) and 54.8% (OR 4.96, 95% CI 2.77–8.88) versus 20.8% with placebo. Treatment-emergent adverse events occurred in 67.2% and 82.3% versus 62.4%, with dizziness the most common (31.5% at 25 mg), and discontinuation due to adverse events reached 14.5% at the higher dose. No deaths or cardiovascular signals were reported.
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The phase 3 X-TOLE2 trial evaluated azetukalner, a novel Kv7 potassium channel opener, as adjunctive therapy in adults with focal epilepsy who had ≥4 focal seizures per month despite stable treatment with 1–3 antiseizure medications. A total of 374 participants across 138 sites were treated with placebo (n=125), azetukalner 15 mg (n=125) or azetukalner 25 mg (n=124) once daily for 12 weeks, without titration. Median monthly seizure frequency fell by 34.5% with 15 mg and 53.2% with 25 mg, compared with 10.4% with placebo (both P<0.001). The ≥50% responder rate was 37.6% (OR 2.41, 95% CI 1.35–4.33) and 54.8% (OR 4.96, 95% CI 2.77–8.88) versus 20.8% with placebo. Treatment-emergent adverse events occurred in 67.2% and 82.3% versus 62.4%, with dizziness the most common (31.5% at 25 mg), and discontinuation due to adverse events reached 14.5% at the higher dose. No deaths or cardiovascular signals were reported.
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