BENITIONSClinical Trial Intelligence

A Study of Soticlestat in Adults and Children With Rare Epilepsies

Фаза 2 Прекращено NCT03635073

ЗаболеваниеEpilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
ФазаФаза 2
СпонсорTakeda
СтатусПрекращено
Участники156 участн.
ВмешательствоSoticlestat
Дата начала19.07.2018
Дата завершения30.07.2025
Публикация результатов19.03.2026

Кратко

The main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment. Participants will receive soticlestat twice a day. Participants will visit the study clinic every 2-6 months throughout the study. Study treatments may continue as long as the participant is receiving benefit from it.

Percentage of Participants Who Experienced At Least One Treatment-emergent Adverse Event (AE)

From screening up to end of the study (up to approximately 84 months) · percentage of participants

Soticlestat91.0 percentage of participants

Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS)

Baseline, Week 338 · score on a scale

Soticlestat32.3 ± 21.64 score on a scale
Soticlestat0.7 ± 0.58 score on a scale
Soticlestat33.5 ± 29.19 score on a scale
Soticlestat-3.0 ± 2.83 score on a scale
Soticlestat12.3 ± 15.89 score on a scale
Soticlestat-5.5 ± 2.12 score on a scale

Change From Baseline in Behavior Measures Using Total Scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for Participants Greater Than Equal to (≥) 6 Years of Age

Baseline, Week 338 · score on a scale

Soticlestat36.8 ± 26.11 score on a scale
Soticlestat-16.3 ± 8.50 score on a scale

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