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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2022-03-04 |
| Est. Completion | 2025-09-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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