Trial · NCT06422377
A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine
NCT06422377, Phase 3, Terminated, Takeda; results first posted 2025-03-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine. Trials, record NCT06422377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06422377
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine
- NCT number
- NCT06422377
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
- Interventions
- Soticlestat
- First posted
- 2024-05-21
- Last updated
- 2026-09-04
- Results first posted
- 2025-03-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During First 12 Weeks of Maintenance Period for DS Participants | Baseline to Week 12 of Maintenance Period | |
| Primary | Percent Change From Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days During First 12 Weeks of Maintenance Period for LGS Participants | Baseline to Week 12 of Maintenance Period |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During First 12 Weeks of Maintenance Period for DS Participants | Baseline to Week 12 of Maintenance Period | The study was terminated by the Sponsor due to a business decision (no safety concerns) as sufficient results were obtained from the previous studies and supplementary data from this study was not required. As there was only 1 participant in this study, no data is reported in order to protect and maintain participant privacy/confidentiality. | ||
| PRIMARY | Percent Change From Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days During First 12 Weeks of Maintenance Period for LGS Participants | Baseline to Week 12 of Maintenance Period | The study was terminated by the Sponsor due to a business decision (no safety concerns) as sufficient results were obtained from the previous studies and supplementary data from this study was not required. As there was only 1 participant in this study, no data is reported in order to protect and maintain participant privacy/confidentiality. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Soticlestat | 1 | |
| Overall Study | COMPLETED | Soticlestat | 0 | |
| Overall Study | NOT COMPLETED | Soticlestat | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Soticlestat | 0 | 0 |
| Total, other adverse events | Soticlestat | 0 | 0 |
| Total, serious adverse events | Soticlestat | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06422377
GET https://conductscience.org/api/trials/v1/NCT06422377/registered