Trial · NCT03635073
A Study of Soticlestat in Adults and Children With Rare Epilepsies
NCT03635073, Phase 2, Terminated, Takeda; results first posted 2026-03-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Soticlestat in Adults and Children With Rare Epilepsies. Trials, record NCT03635073. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03635073
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Soticlestat in Adults and Children With Rare Epilepsies
- NCT number
- NCT03635073
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 156 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Epilepsy, Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
- Interventions
- Soticlestat
- First posted
- 2018-08-17
- Last updated
- 2026-09-04
- Other registries' IDs
- eudract:2018-002485-39
- Results first posted
- 2026-03-19
- Limitations and caveats
- The study was terminated early based on Sponsor's decision.
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Experienced At Least One Treatment-emergent Adverse Event (AE) | From screening up to end of the study (up to approximately 84 months) | An Adverse Event (AE) was defined any untoward medical occurrence in a subject or clinical study subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign vital sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to this medicinal product. A TEAE is defined as any AE that starts or increases in severity during or after the first dose of study drug. |
| Primary | Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS) | Baseline, Week 338 | VABS,3rd edition,Parent Caregiver Form:parent-report questionnaire of adaptive functioning/how is individual's routine behaviour at home \& in community.4 domains(Communication,Daily Living,Social Skills\&Relationships,Problem Behaviors) contained 12 subdomains including items(each scored 0-2).Subdomain scores=sum of item scores within that subdomain.Ranges of subdomain scores are:Communication:Listening\&Understanding(0-78);Talking(0-98);Reading\&Writing(0-76),Daily Living:Caring for Self(0-110);Caring for Home(0-60);Living in Community(0-116),Social Skills\&Relationships:Relating to Others(0-86);Playing\&Using Leisure Time(0-72);Adapting(0-66),Problem Behaviors:Section A(0-26);Section B(0-22),Section C(0-40).For 1st 3 domains,higher subdomain scores=higher adaptive functioning,positive CFB=improvement.For Problem Behaviors,higher subdomain scores=more problem behaviors,negative CFB=improvement(reduction in problem behaviors).No subdomain scores combined to compute any total score. |
| Primary | Change From Baseline in Behavior Measures Using Total Scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for Participants Greater Than Equal to (≥) 6 Years of Age | Baseline, Week 338 | The ABC-C measures psychiatric symptoms and behavioral disturbance exhibited by individuals across 5 subscales with 58 items: Irritability subscale (15 items); Lethargy/Social Withdrawal subscale (16 items); Stereotypic Behavior subscale (7 items); Hyperactivity subscale (16 items); and Inappropriate Speech subscale (4 items). Each item is rated on a scale of 0 to 3 ("not at all a problem" to "the problem is severe in degree"). The total score was calculated by summing the scores on all 58 items where the total scores ranged from 0 to 174. Higher scores indicate more severity in psychiatric symptoms and behavioral disturbance. Negative change from baseline scores represents improvement. Positive change from baseline scores represents worsening. |
| Primary | Change From Baseline in Behavior Measures Using Subscale Scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for Participants Greater Than Equal to (≥) 6 Years of Age | Baseline, Week 338 | The ABC-C measures psychiatric symptoms and behavioral disturbance exhibited by individuals across 5 subscales with 58 items: Irritability subscale (15 items: Ranges from 0 to 45); Lethargy/Social Withdrawal subscale (16 items: Ranges from 0 to 48); Stereotypic Behavior subscale (7 items: Ranges from 0 to 21); Hyperactivity subscale (16 items: Ranges from 0 to 48); and Inappropriate Speech subscale (4 items: Ranges from 0 to 12). Each item is rated on a scale of 0 to 3 ("not at all a problem" to "the problem is severe in degree"). Subscale scores are calculated as the sum of items within the subscale. Higher subscale scores indicate more severity in psychiatric symptoms and behavioral disturbance. Negative change from baseline score represents improvement. Positive change from baseline score represents worsening. |
| Primary | Number of Participants With Changes From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Categorization Based on Columbia Classification Algorithm of Suicide Assessment Categories 1,2,3,4, and 5 for Participants ≥6 Years of Age | Baseline, Week 338 | Suicidal ideation and behavior was assessed in participants with at least 6 years of age using the C-SSRS. The C-SSRS is a 3-part scale that measures suicidal ideation (eg, participants endorses thoughts about a wish to be dead or has other thoughts of suicide), intensity of ideation (frequency), and suicidal behavior (actually, interrupted, and aborted attempts at suicide). SI=Suicidal Ideation; SB=Suicidal Behavior and NSSJB=Non-suicidal Self-injurious Behavior for the categories reported. BL denotes Baseline, V denotes Visit and W denotes Week in the categories. |
| Primary | Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Grams Per Liter (g/L)) | Baseline, Week 338 | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. |
| Primary | Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Units Per Liter (U/L)) | Baseline, Week 338 | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. |
| Primary | Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Micromoles Per Liter (µmol/L)) | Baseline, Week 338 | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. |
| Primary | Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Millimoles Per Liter (mmol/L)) | Baseline, Week 338 | BL denotes Baseline, CFB denotes Change from Baseline, W denotes Week, HDL denotes High Density Lipid and LDL denotes Low Density Lipid for the reported categories. |
| Primary | Change From Baseline in Clinical Laboratory Parameters: Haematology (10^9 Cells Per Liter (10^9 Cells/L)) | Baseline, Week 338 | BL denotes Baseline, CFB denotes Change from Baseline and W denotes Week for the reported categories. |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experienced At Least One Treatment-emergent Adverse Event (AE) | From screening up to end of the study (up to approximately 84 months) | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. | percentage of participants | NUMBER |
| PRIMARY | Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS) | Baseline, Week 338 | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time points. Baseline is denoted as BL, change from baseline as CFB and Week as W for the reported categories. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Behavior Measures Using Total Scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for Participants Greater Than Equal to (≥) 6 Years of Age | Baseline, Week 338 | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number analyzed is the number of participants with data available for analysis at the specified time points. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Behavior Measures Using Subscale Scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for Participants Greater Than Equal to (≥) 6 Years of Age | Baseline, Week 338 | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. | score on a scale | MEAN |
| PRIMARY | Number of Participants With Changes From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Categorization Based on Columbia Classification Algorithm of Suicide Assessment Categories 1,2,3,4, and 5 for Participants ≥6 Years of Age | Baseline, Week 338 | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Only participants with change from baseline in C-SSRS are included in the categories. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Grams Per Liter (g/L)) | Baseline, Week 338 | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number analyzed is the number of participants with data available for analysis at specified timepoints. | g/L | MEAN |
| PRIMARY | Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Units Per Liter (U/L)) | Baseline, Week 338 | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number analyzed is the number of participants with data available for analysis at specified timepoints for specified category. | U/L | MEAN |
| PRIMARY | Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Micromoles Per Liter (µmol/L)) | Baseline, Week 338 | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number analyzed is the number of participants with data available for analysis at specified timepoints for specified category. | µmol/L | MEAN |
| PRIMARY | Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Millimoles Per Liter (mmol/L)) | Baseline, Week 338 | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Number analyzed is the number of participants with data available for analysis at specified timepoints for specified category. | mmol/L | MEAN |
| PRIMARY | Change From Baseline in Clinical Laboratory Parameters: Haematology (10^9 Cells Per Liter (10^9 Cells/L)) | Baseline, Week 338 | Safety Analysis Set included all enrolled participants who took at least 1 dose of study medication. Overall number analyzed is the number of participants with data available for analysis at baseline. Number analyzed is the number of participants with data available for analysis at specified timepoints for specified category. | 10^9 cells/L | MEAN |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group195
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Experienced At Least One Treatment-emergent Adverse Event (AE) | Soticlestat | 91.0 | percentage of participants | ||
| Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS) | Soticlestat | BL: Communication: Listening And Understanding | 32.3 | Standard Deviation 21.64 | score on a scale |
| Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS) | Soticlestat | CFB at W 338: Communication: Listening And Understanding | 0.7 | Standard Deviation 0.58 | score on a scale |
| Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS) | Soticlestat | BL: Communication: Talking | 33.5 | Standard Deviation 29.19 | score on a scale |
| Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS) | Soticlestat | CFB at W 338: Communication: Talking | -3.0 | Standard Deviation 2.83 | score on a scale |
| Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS) | Soticlestat | BL: Communication: Reading And Writing | 12.3 | Standard Deviation 15.89 | score on a scale |
| Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS) | Soticlestat | CFB at W 338: Communication: Reading And Writing | -5.5 | Standard Deviation 2.12 | score on a scale |
| Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS) | Soticlestat | BL: Daily Living: Caring For Self | 35.1 | Standard Deviation 27.52 | score on a scale |
| Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS) | Soticlestat | CFB at W 338: Daily Living: Caring For Self | -1.5 | Standard Deviation 13.44 | score on a scale |
| Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS) | Soticlestat | BL: Daily Living: Caring For Home | 11.1 | Standard Deviation 10.63 | score on a scale |
1 to 10 of 195Source ClinicalTrials.gov
See all 195 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Soticlestat | 156 | |
| Overall Study | COMPLETED | Soticlestat | 0 | |
| Overall Study | NOT COMPLETED | Soticlestat | 156 |
Source ClinicalTrials.gov
Adverse events86
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Soticlestat | 21 | 156 | |
| other | Constipation | Gastrointestinal disorders | Soticlestat | 16 | 156 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Soticlestat | 21 | 156 | |
| other | Diarrhoea | Gastrointestinal disorders | Soticlestat | 16 | 156 | |
| other | Fatigue | General disorders | Soticlestat | 10 | 156 | |
| other | Gastroenteritis | Infections and infestations | Soticlestat | 8 | 156 | |
| other | Insomnia | Psychiatric disorders | Soticlestat | 14 | 156 | |
| other | Irritability | Psychiatric disorders | Soticlestat | 9 | 156 | |
| other | Nasopharyngitis | Infections and infestations | Soticlestat | 24 | 156 | |
| other | Pneumonia | Infections and infestations | Soticlestat | 8 | 156 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Soticlestat | 4 | 156 |
| Total, other adverse events | Soticlestat | 120 | 156 |
| Total, serious adverse events | Soticlestat | 43 | 156 |
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/NCT03635073
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