Trial · NCT05163314
A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
NCT05163314, Phase 3, Terminated, Takeda
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome. Trials, record NCT05163314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05163314
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
- NCT number
- NCT05163314
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 352 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)
- Interventions
- Soticlestat
- First posted
- 2021-12-20
- Last updated
- 2026-09-04
- Other registries' IDs
- eudract:2021-002482-17
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE) | Up to end of study (approximately 3.6 years) | 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 increased in severity after the first dose of the study drug in this open label extension (OLE) study. |
| Primary | Number of Participants in Each Category of the Columbia-Suicide Severity Rating Scale (C-SSRS) Over Time | At first visit post-baseline (Visit 1 [V1], Day 1 of the current study), Week 13 (V4), Week 26 (V5), Week 52 (V7), Week 78 (V9), Week104 (v11), Week 130 (V12) and Week 156 (V13) | C-SSRS systematically tracks suicidal ideation and behavior. Responses to questions in the C-SSRS at baseline and each post-baseline time point were collected for participants ≥6 years of age. C-SSRS incidences were categorized as follows: No Suicidal Ideation or Suicidal Behavior or Non-suicidal Self-injurious Behavior (No SI or SB or NSSJB), Non-suicidal Self-injurious Behavior (NSSJB), Suicidal Ideation (SI), and Suicidal Behavior (SB). For each visit (V), the "Yes" answer to the question with the highest severity rank was used to determine the C-SSRS category of a participant. The category Missing indicates the number of participants for whom no data was collected at the particular time point. For each time point only categories with at least 1 participant are presented. BL denotes Baseline and W denotes Week for the reported categories. |
| Primary | Change From Baseline in Body Weight for All Age Groups | From Baseline to Week 104 | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. |
| Primary | Change From Baseline in Height for All Age Groups | Baseline to Week 104 | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. |
| Primary | Number of Participants in Each Tanner Stage for Children 6 to 17 Years of Age During the Study | From Baseline to Week 130 | Tanner assessment scores were used to document the stage of development of puberty by assessing the secondary sexual characteristics, rated in 5 stages: Stage 1 (no development) to 5 (adult-like development in quantity and size) by age (6 to 17 years of age) and sex (boys and girls) during the study. Tanner scale boy clinical classification test names for each stage are reported as follows: TANN02-Genitalia and TANN02-Pubic Hair. Tanner scale girl clinical classification test names for each stage are reported as follows: TANN01-Breast and TANN01-Pubic Hair. |
| Primary | Absolute Value for Insulin-like Growth Factor 1 (IGF-1) for Children 2 to 17 Years of Age During the Study | From Baseline to Week 130 | Absolute values of IGF1 were summarized descriptively as a continuous variable by age and by sex (male and female). If multiple assessments for a participant at different visits at a particular age were available, then the average of all data for that participant were used for the summary. |
| Secondary | Percent Change From Baseline in Total Seizure Frequency Per 28 Days | From Baseline to Week 156 | Seizure frequency per 28 days was defined as total number of seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline was defined as (frequency of seizures per 28 days during Treatment Period - frequency of seizures per 28 days at Baseline) divided by the frequency of seizures per 28 days at Baseline multiplied by 100. |
| Secondary | Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in DS Cohort | From Baseline to Week 156 | Convulsive seizure frequency per 28 days was defined as total number of convulsive seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline was defined as (frequency of convulsive seizures per 28 days during Treatment Period - frequency of convulsive seizures per 28 days at Baseline) divided by the frequency of convulsive seizures per 28 days at Baseline multiplied by 100. |
| Secondary | Percent Change From Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days in LGS Cohort | From Baseline to Week 144 | MMD seizure frequency per 28 days was defined as the total number of MMD seizures reported during the period divided by the number of days during the period seizures were assessed multiplied by 28. Percent change from baseline was defined as (frequency of MMD seizures per 28 days during the Treatment Period - frequency of MMD seizures per 28 days at Baseline) divided by the frequency of MMD seizures per 28 days at Baseline multiplied by 100. |
| Secondary | Number of Participants With Improvement in the Clinical Global Impression of Improvement (CGI-I) Score | From Baseline to Week 156 | The CGI-I Clinician is a 7-point Likert scale that the investigator uses to rate a participant's change in overall seizure control, behavior, safety and tolerability, after the initiation of study drug relative to Baseline (before treatment with study drug). The participants were rated as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). Reported here is the number of participants with improvement, which includes the CGI-I responses: very much improved, much improved, minimally improved. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
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/NCT05163314
GET https://conductscience.org/api/trials/v1/NCT05163314/registered