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NCT04938427 · ClinicalTrials.gov registry record · Phase 3
A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 270
- Enrollment target
NCT04938427 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 270 participants.
The verdict
NCT04938427, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 270 participants
- Enrollment target
Study Summary
The aims of the study are: * to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome. * to assess the safety profile of soticlestat when given in combination with other therapies. Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.
Interventions
- DRUG Placebo
- DRUG Soticlestat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2021-11-08 |
| Est. Completion | 2024-01-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04938427
The ClinicalTrials.gov registry entry for NCT04938427 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 270 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 2 interventions - of which Placebo is the first listed.
NCT04938427 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04938427 about?
NCT04938427 is a clinical study titled "A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome". The aims of the study are: * to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome. * to assess the safety profile of soticlestat when given in combination with other therapies. Partici...
What is the current status of trial NCT04938427?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2021-11-08. Estimated completion is 2024-01-25.
What interventions are being tested in trial NCT04938427?
The interventions under investigation include: Placebo (DRUG), Soticlestat (DRUG).
Who is sponsoring clinical trial NCT04938427?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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