Soticlestat for Seizure Reduction in Children With Dravet Syndrome, Lennox-Gastaut Syndrome

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Among children with Dravet syndrome (DS), soticlestat therapy significantly reduced placebo-adjusted seizure frequency. Among children with Lennox-Gastaut syndrome (LGS), a directional reduction in seizure frequency was observed with soticlestat therapy. These findings were presented at the American Academy of Neurology (AAN) 2021 Virtual Annual Meeting, held April 17 to 22, 2021.

In collaboration with the Takeda Pharmaceutical Company Limited and Ovid Therapeutics, study researchers recruited children with DS (n=51) and LGS (n=88) aged 2 to 17 years for this phase 2, multicenter, randomized, placebo-controlled, double-blind parallel-group study (ClinicalTrials.gov Identifier NCT03650452).

The children were given 600 mg/day or less (dosage adjusted for weight) of soticlestat (TAK-935/OV935) or placebo for 20 weeks. Study researchers compared seizure frequency with that seen at baseline, when children with DS had 3 or more convulsive seizures and children with LGS had 4 or more drop seizures per month.

Soticlestat therapy caused a 25.1% reduction of seizures (P =.0024) during the 20-week treatment period. The median placebo-adjusted frequency decreased by 46.0% (P =.0007) among the DS cohort. The children with LGS, however, did not have a significant reduction of seizures in the subgroup analysis (14.8%; P =.1279) compared with baseline.

Treatment-emergent adverse events were reported by 80.3% of the soticlestat and 74.3% of the placebo cohorts. The treatment group participants reported a 5% or greater difference in lethargy and constipation than the placebo recipients.

Serious adverse events were reported among 15.5% of the treatment and 18.6% of the placebo groups.

These data indicated soticlestat treatment significantly reduced placebo-adjusted seizure frequency among children with seizure conditions which are often resistant to therapies, especially for children with DS. The risk for adverse events was relatively low and similar to reactions observed among the placebo cohort.

Disclosure: This clinical trial was supported by y Takeda Pharmaceutical Company Limited and Ovid Therapeutics Inc. Please refer to the original article for a full list of disclosures.

Reference

Hahn CD, Jiang Y, Villanueva V, et al. Efficacy, safety and tolerability of soticlestat (TAK-935/OV935) as adjunctive therapy in pediatric patients with Dravet syndrome and Lennox-Gastaut syndrome (ELEKTRA). Presented at the American Academy of Neurology 2021 virtual annual meeting; 2021. Abstract S1.005