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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: Clinical Trial Phase 3 study, sponsored by Takeda.
NCT05163314 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 352 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE was therefore any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it was considered related to the drug. A TEAE was defined as any AE that started or incr
Interventions
- DRUG Soticlestat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2022-03-04 |
| Est. Completion | 2025-09-24 |
| Phase | Phase 3 |
Why NCT05163314 stopped before completion
NCT05163314 is an interventional study that assigns participants to a tested intervention. The registered 352 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 1 intervention - of which Soticlestat is the first listed.
NCT05163314 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05163314's enrollment target sits among peer trials
352 1030th of 2000 higher than 968 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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