Trial · NCT03650452
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
NCT03650452, Phase 2, Completed, Takeda; results first posted 2021-02-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies. Trials, record NCT03650452. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03650452
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
- NCT number
- NCT03650452
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 141 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Interventions
- TAK-935, Placebo
- First posted
- 2018-08-28
- Last updated
- 2026-09-14
- Other registries' IDs
- eudract:2018-002484-25
- Results first posted
- 2021-02-18
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period | Baseline; Maintenance Period: Weeks 9 to 20 | Seizure frequency per 28 days is defined as total number of seizures (convulsive seizures for DS, drop seizures for LGS) reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline is defined as (frequency of seizures per 28 days during maintenance period - frequency of seizures per 28 days at baseline) divided by frequency of seizures per 28 days at baseline multiplied by 100. Negative percent change from Baseline indicates improvement. |
| Secondary | Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Period | Baseline; Treatment Period: Weeks 0 to 20 | Seizure Frequency per 28 days is defined as total number of Seizures reported (convulsive seizures for DS, drop seizures for LGS) during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent Change from Baseline is defined as (frequency of seizures per 28 days during treatment period - frequency of seizures per 28 days at baseline) divided by frequency of seizures per 28 days at baseline multiplied by 100. Negative percent change from Baseline indicates improvement. |
| Secondary | Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in Participants With Dravet Syndrome Stratum During the Maintenance Period | Baseline; Maintenance Period: Weeks 9 to 20 | Convulsive seizure frequency per 28 days is 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 (%) is defined as \[(Maintenance Period Convulsive Seizure Frequency - Baseline Period Convulsive Seizure Frequency) divided by Baseline Convulsive Seizure Frequency\] multiplied by 100. Negative percent change from Baseline indicates improvement. |
| Secondary | Percent Change From Baseline in Drop Seizure Frequency Per 28 Days in Participants With the Lennox-Gastaut Syndrome (LGS) Stratum During the Maintenance Period | Baseline; Maintenance Period: Weeks 9 to 20 | Drop seizure frequency per 28 days is defined as total number of drop seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent Change from Baseline (%) is defined as \[(Maintenance Period Drop Seizure Frequency - Baseline Period Drop Seizure Frequency) divided by Baseline Drop Seizure Frequency\] multiplied by 100. Negative percent change from Baseline indicates improvement. |
| Secondary | Percentage of Participants With LGS Stratum Considered Treatment Responders Throughout the Maintenance Period | Maintenance Period: Weeks 9 to 20 | Responders are defined as having over 50% drop seizure reduction compared to Baseline. Percent Reduction from Baseline (%) is defined as \[(Maintenance Period Drop Seizure Frequency - Baseline Period Drop Seizure Frequency) divided by Baseline Drop Seizure Frequency\] multiplied by 100. Data is reported as reduction of 25%, 50%, 75% and 100% or more in drop seizures from Baseline. |
| Secondary | Percentage of Participants With Dravet Syndrome Stratum Considered Treatment Responders Throughout the Maintenance Period | Maintenance Period: Weeks 9 to 20 | Responders are defined as having over 50% convulsive seizure reduction compared to Baseline. Percent Reduction from Baseline (%) is defined as \[(Maintenance Period Convulsive Seizure Frequency - Baseline Period Convulsive Seizure Frequency) divided by Baseline Convulsive Seizure Frequency\] multiplied by 100. Data is reported as reduction of 25%, 50%, 75% and 100% or more in drop seizures from Baseline. |
| Secondary | Change From Baseline in Clinician's Clinical Global Impression of Severity (CGI-S) Responses of Investigator Reported Impression of Efficacy and Tolerability of Study Drug | Baseline and Week 20 | The CGI-Severity (CGI-S) focuses on clinicians' observations of the participant's cognitive, functional, and behavioral performance since the beginning of the study. The CGI-S is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill participants). A negative change from Baseline indicates improvement. |
| Secondary | Percentage of Participants With Clinical Global Impression of Change (CGI-C) Responses as Per the Investigator Reported Impression of Efficacy and Tolerability TAK-935 | Week 20 | CGI-Change (CGI-C) treatment response ratings should take account of both therapeutic efficacy and treatment-related AEs. Each component of the CGI is rated separately; the instrument does not yield a global score. The CGI-C is rated on a 7-point scale, where, 0 = Marked improvement and no side-effects, 1 = Marked improvement and minimal side-effects, 2 = No Change, 3 = Minimal improvement and marked side-effects and 4 = Unchanged or worse and side-effects outweigh the therapeutic effect. Lower scores indicated improvement. |
| Secondary | Percentage of Participants With Caregiver Global Impression of Change (Care GI-C) Responses as Per the Parent/Family Reported Impression of Efficacy and Tolerability of TAK-935 | Week 20 | The Care GI-C is rated on a 7-point scale, with the severity of illness scale where, 1 = Very much improved, 2 = Much improved, 3 = Slightly improved, 4 = No change, 5 = Slightly worse, 6 = Much worse and 7 = Very much worse. Lower scores indicated improvement. |
| Secondary | Change From Baseline in Plasma 24S-Hydroxycholesterol (24HC) Levels in Participants Treated With TAK-935 as an Adjunctive Therapy | Baseline and Week 24 | A negative change from Baseline indicates improvement. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 Seizure Frequency Per 28 Days During the Maintenance Period | Baseline; Maintenance Period: Weeks 9 to 20 | Efficacy Analysis Set included all Modified Intent-to-Treat (mITT) participants whose efficacy assessments were compliant with Protocol Amendment 2. Overall number analyzed is the number of participants with data available for analyses. | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Period | Baseline; Treatment Period: Weeks 0 to 20 | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in Participants With Dravet Syndrome Stratum During the Maintenance Period | Baseline; Maintenance Period: Weeks 9 to 20 | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. Overall number analyzed is the number of participants with data available for analyses. | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Drop Seizure Frequency Per 28 Days in Participants With the Lennox-Gastaut Syndrome (LGS) Stratum During the Maintenance Period | Baseline; Maintenance Period: Weeks 9 to 20 | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. Overall number analyzed is the number of participants with data available for analyses. | percent change | MEDIAN |
| SECONDARY | Percentage of Participants With LGS Stratum Considered Treatment Responders Throughout the Maintenance Period | Maintenance Period: Weeks 9 to 20 | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. Only participants with LGS stratum indication were analyzed for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Dravet Syndrome Stratum Considered Treatment Responders Throughout the Maintenance Period | Maintenance Period: Weeks 9 to 20 | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. Only participants with Dravet syndrome stratum indication were analyzed for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Clinician's Clinical Global Impression of Severity (CGI-S) Responses of Investigator Reported Impression of Efficacy and Tolerability of Study Drug | Baseline and Week 20 | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. Overall number analyzed is the number of participants with data available for analyses. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Clinical Global Impression of Change (CGI-C) Responses as Per the Investigator Reported Impression of Efficacy and Tolerability TAK-935 | Week 20 | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. Overall number analyzed is the number of participants with data available for analyses. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Caregiver Global Impression of Change (Care GI-C) Responses as Per the Parent/Family Reported Impression of Efficacy and Tolerability of TAK-935 | Week 20 | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2. Overall number analyzed is the number of participants with data available for analyses. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Plasma 24S-Hydroxycholesterol (24HC) Levels in Participants Treated With TAK-935 as an Adjunctive Therapy | Baseline and Week 24 | Efficacy Analysis Set included all mITT participants whose efficacy assessments were compliant with Protocol Amendment 2, with available data. Number analyzed is the number of participants with Baseline and Week 24 data available for analyses. | mg/dL | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period | Placebo | 3.11 | Full Range -78.8 to 163.0 | percent change | |
| Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period | TAK-935 | -27.76 | Full Range -100.0 to 160.6 | percent change | |
| Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Period | Placebo | 0.75 | Full Range -60.1 to 437.8 | percent change | |
| Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Period | TAK-935 | -30.05 | Full Range -100.0 to 347.5 | percent change | |
| Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in Participants With Dravet Syndrome Stratum During the Maintenance Period | Placebo | 9.38 | Full Range -47.3 to 153.5 | percent change | |
| Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in Participants With Dravet Syndrome Stratum During the Maintenance Period | TAK-935 | -36.50 | Full Range -100.0 to 84.1 | percent change | |
| Percent Change From Baseline in Drop Seizure Frequency Per 28 Days in Participants With the Lennox-Gastaut Syndrome (LGS) Stratum During the Maintenance Period | Placebo | -1.90 | Full Range -78.8 to 163.0 | percent change | |
| Percent Change From Baseline in Drop Seizure Frequency Per 28 Days in Participants With the Lennox-Gastaut Syndrome (LGS) Stratum During the Maintenance Period | TAK-935 | -18.46 | Full Range -100.0 to 160.6 | percent change | |
| Percentage of Participants With LGS Stratum Considered Treatment Responders Throughout the Maintenance Period | Placebo | Reduction of 25% or More in Drop Seizures from Baseline | 29.7 | 95% Confidence Interval 15.9 to 47.0 | percentage of participants |
| Percentage of Participants With LGS Stratum Considered Treatment Responders Throughout the Maintenance Period | TAK-935 | Reduction of 25% or More in Drop Seizures from Baseline | 42.5 | 95% Confidence Interval 27.0 to 59.1 | percentage of participants |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 70 | |
| Overall Study | STARTED | TAK-935 | 71 | |
| Overall Study | COMPLETED | Placebo | 60 | |
| Overall Study | COMPLETED | TAK-935 | 66 | |
| Overall Study | NOT COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | TAK-935 | 5 |
Source ClinicalTrials.gov
Adverse events390
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 | Nasopharyngitis | Infections and infestations | Placebo | 6 | 70 | |
| other | Nasopharyngitis | Infections and infestations | TAK-935 | 6 | 71 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 10 | 70 | |
| other | Upper respiratory tract infection | Infections and infestations | TAK-935 | 12 | 71 | |
| other | Pyrexia | General disorders | Placebo | 8 | 70 | |
| other | Pyrexia | General disorders | TAK-935 | 11 | 71 | |
| other | Seizure | Nervous system disorders | Placebo | 7 | 70 | |
| other | Seizure | Nervous system disorders | TAK-935 | 4 | 71 | |
| other | Somnolence | Nervous system disorders | Placebo | 3 | 70 | |
| other | Somnolence | Nervous system disorders | TAK-935 | 6 | 71 |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 70 |
| Total, all-cause mortality | TAK-935 | 0 | 71 |
| Total, other adverse events | Placebo | 52 | 70 |
| Total, other adverse events | TAK-935 | 55 | 71 |
| Total, serious adverse events | Placebo | 13 | 70 |
| Total, serious adverse events | TAK-935 | 11 | 71 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35841234 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TAK-935 vs Placebo: deaths from any cause | Trial comparisons |
| TAK-935 vs Placebo: serious adverse events | Trial comparisons |
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/NCT03650452
GET https://conductscience.org/api/trials/v1/NCT03650452/results?page=2