Trial intelligence / Profile preview

Long-Term Safety and Tolerability of Soticlestat in Developmental Epileptic Encephalopathies (ENDYMION 1)

NCT03635073Phase 2Terminated

Sponsor
Takeda
Start
Jul 2018
Primary completion
Jul 2025
Modality
Small Molecules
Countries
8
01

Overview

Phase 2, open-label, single-arm trial of soticlestat in developmental and epileptic encephalopathy (DEE), Dravet syndrome, Lennox-Gastaut syndrome (LGS) and 2 more, sponsored by Takeda. Primary endpoints: Treatment-emergent Adverse Event up to 84 months, Vineland Adaptive Behavior Scale at Week 338 and 7 more. Started Jul 2018; status: terminated.

02

Drugs

soticlestat
03

Conditions

developmental and epileptic encephalopathy (DEE)Dravet syndromeLennox-Gastaut syndrome (LGS)CDKL5 deficiency disorder (CDD)chromosome 15q11.2-q13.1 duplication syndrome (Dup15q)

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