deltatrials
Terminated PHASE3 INTERVENTIONAL 1-arm NCT06422377

A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine

An Open-label, Nonrandomized, Phase 3 Study to Evaluate the Efficacy and Safety of Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine

Sponsor: Takeda

Interventions Soticlestat
Updated 6 times since 2024 Last updated: Jul 16, 2025 Started: Apr 25, 2024 Primary completion: Aug 14, 2024 Completion: Aug 14, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Business decision unrelated to patient safety.

A PHASE3 clinical study on Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), this trial is terminated or withdrawn. The trial is conducted by Takeda and has accumulated 6 data snapshots since 2024. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Apr 2025 · 6 months · monthly snapshotTerminated~Apr 2025 – ~Aug 2025 · 4 months · monthly snapshotTerminated~Aug 2025 – present · 13 months · monthly snapshotTerminated

Change History

6 versions recorded
  1. Aug 2025 — Present [monthly]

    Terminated PHASE3

  2. Apr 2025 — Aug 2025 [monthly]

    Terminated PHASE3

  3. Oct 2024 — Apr 2025 [monthly]

    Terminated PHASE3

    Status: RecruitingTerminated

  4. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

Show 1 earlier version
  1. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

    First recorded

Apr 2024

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Takeda
Data source: Takeda

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations