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A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of Soticlestat (TAK-935) as Adjunctive Therapy in Subjects With Developmental Epileptic Encephalopathies Including Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome (ENDYMION 1)

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Trial Profile

A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of Soticlestat (TAK-935) as Adjunctive Therapy in Subjects With Developmental Epileptic Encephalopathies Including Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome (ENDYMION 1)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 06 Oct 2025

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At a glance

  • Drugs Soticlestat (Primary) ; Soticlestat (Primary)
  • Indications Dravet syndrome; Early infantile epileptic encephalopathy 2; Encephalopathy; Epilepsy; Lennox-Gastaut syndrome
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ENDYMION 1
  • Sponsors Ovid Therapeutics; Takeda; Takeda Development Center Americas

Most Recent Events

  • 05 Sep 2025 Status changed from active, no longer recruiting to discontinued because supplementary data from this study is no longer necessary as determined from the negative results from phase 3 SKYLINE and SKYWAY studies (unrelated to safety). Therefore, Takeda has made a decision to close it.
  • 18 May 2023 Planned End Date changed from 21 Nov 2024 to 22 May 2026.
  • 18 May 2023 Planned primary completion date changed from 21 Nov 2024 to 22 May 2026.

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