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NCT05163314 · ClinicalTrials.gov registry record · Phase 3

A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

A Phase 3 study, sponsored by Takeda.

Terminated
Registry status
Phase 3
Development phase
352
Enrollment target

NCT05163314 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 352 participants.

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The verdict

NCT05163314, a Phase 3 study, was terminated before completion, sponsored by Takeda.

TERMINATED
Registry status
Phase 3
Development phase
352 participants
Enrollment target

Study Summary

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.

Interventions

  • DRUG Soticlestat

Trial Details

FieldValue
Enrollment Target 352 participants
Start Date 2022-03-04
Est. Completion 2025-09-24
Phase Phase 3

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT05163314

The ClinicalTrials.gov registry entry for NCT05163314 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 352 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Soticlestat is the first listed.

NCT05163314 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05163314 about?

NCT05163314 is a clinical study titled "A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome". The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There ...

What is the current status of trial NCT05163314?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 352 participants. The study started on 2022-03-04. Estimated completion is 2025-09-24.

What interventions are being tested in trial NCT05163314?

The interventions under investigation include: Soticlestat (DRUG).

Who is sponsoring clinical trial NCT05163314?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.