ReviewFrontiers in pharmacology2025
Efficacy, safety, and tolerability of soticlestat (TAK-935) as adjunctive therapy in pediatric patients with dravet syndrome and Lennox-Gastaut syndrome: a meta-analysis of 3 randomized controlled trials.
Review in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Unraveling Lennox-Gastaut Syndrome: From Molecular Pathogenesis to Precision Diagnosis and Targeted Therapy Evolving Therapeutic Strategies.International journal of molecular sciences · 2026Review
- Structure-Activity Relationship Study on Soticlestat Derivatives for the Discovery of CYP46A1 (CH24H) Inhibitors.Molecules (Basel, Switzerland) · 2026Article
- From Symptomatic Therapies to Disease-Modifying Approaches for Neuronal Sodium Channel Disorders.International journal of molecular sciences · 2025Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: To evaluate the efficacy, safety, and tolerability of soticlestat as adjunctive therapy in pediatric patients with epileptic encephalopathies of Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). Method: We performed a computerized literature search of MEDLINE, EMBASE, Cochrane Library, Web of Science, Google Scholar, and ClinicalTrials.gov to identify eligible randomized, placebo-controlled trials (RCTs) until December 2024. We calculated risk ratios (RRs) for efficacy of responder rate, and tolerability profiles in terms of serious adverse event (SAE) and dropout for adverse events as well as the most common side effects. Quality assessment of included RCTs was performed using the Cochrane Collaboration tool. Results: A total of 3 RCTs with 553 patients were included in the current study. Pooled RR for responder was 3.88 (95% CI 1.78-8.49, P = 0.001) among patients with DS, and for patients with LGS was 1.56 (95% CI 0.91-2.68, P = 0.11). Significantly more patients receiving soticlestat experienced discontinuation than placebo (RR 2.82 1.49-5.33, P = 0.001) because of adverse events. No significant difference in SAE was observed between the two treatment groups with RR 0.87 (95% CI 0.55-1.39, P = 0.57). Among the most common AE, only constipation occurred more often in the soticlestat group (RR 3.71, 95% CI 1.22-11.31, P = 0.02). Conclusion: Soticlestat showed significantly higher efficacy in reducing convulsive seizures in patients with DS. Nonetheless, for patients with LGS, the difference between soticlestat and placebo was not statistically significant. The incidence of SAE in patients receiving soticlestat was similar to those receiving placebo; however, substantially more patients allocated to soticlestat discontinued prematurely because of side effects.
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