Soticlestat as an adjunctive therapy in children and young adults with Dravet syndrome.

The exploratory SCN1A + subgroup analysis (79% of study participants) showed a nominally significant reduction from baseline in convulsive seizure frequency ( p = .045) with soticlestat versus placebo.

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Effect on convulsive seizure frequency Soticlestat reduced convulsive seizure frequency compared with placebo in participants with DS, but this difference did not reach statistical significance.

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Narrowly missed significance on the primary endpoints is unlikely to be due to a high placebo response, as the placebo rate was in line with clinical trials of other approved drugs for the treatment of DS. 28 , 29 , 30 , 31 However, as mentioned above, the observed placebo response in this trial was higher than in the phase 2 study.

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Potential contributors to this narrowly missed statistical significance on the primary outcome are a higher placebo response than in the phase 2 study and a generally more refractory patient population (median [range] number of prior or baseline ASMs was 8 [3–27]).

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