Trial · NCT03373383
Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
NCT03373383, Phase 2, Completed, UCB Biopharma S.P.R.L.; results first posted 2021-04-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy. Trials, record NCT03373383. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03373383
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
- NCT number
- NCT03373383
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 411 participants, actual
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Conditions
- Drug-resistant Epilepsy, Focal-Onset Seizures
- Interventions
- Padsevonil, Placebo
- First posted
- 2017-12-14
- Last updated
- 2023-12-19
- Other registries' IDs
- eudract:2017-003200-48
- Results first posted
- 2021-04-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Log-transformed Observable Focal Onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period | From Baseline over the 12 Week Maintenance Period | During the study, participants kept diaries to record daily seizure activity. Seizure frequency refers to 28-day adjusted frequency. Seizure frequency was based on investigator assessment of participants' reports of daily seizure type and frequency. Observable focal-onset seizures refer to Type IA1, IB, and IC (ILAE Classification of Epileptic Seizures, 1981). Based on ANCOVA on change in log-transformed, 28-day adjusted seizure frequency from Baseline with treatment group as the main factor, Baseline log-transformed seizure frequency as a continuous covariate, Baseline SV2A use (yes or no) and Region (Europe, Non-Europe) as categorical factors. |
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject and/or Caregiver or Observed by the Investigator During the Entire Study | From Baseline until Safety Follow-Up (up to Week 23) | An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. |
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal | From Baseline until Safety Follow-Up (up to Week 23) | An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. |
| Primary | Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) During the Entire Study | From Baseline until Safety Follow-Up (up to Week 23) | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. |
| Secondary | 75 % Responder Rate Over the 12 Week Maintenance Period | End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization | The 75% responder rate, where a responder is a participant experiencing a ≥75% reduction in observable focal-onset seizure frequency from Baseline, over the 12-Week Maintenance Period. |
| Secondary | 50 % Responder Rate Over the 12 Week Maintenance Period | End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization | The 50% responder rate, where a responder was a participant experiencing a ≥50% reduction in observable focal-onset seizure frequency from Baseline, over the 12-Week Maintenance Period. |
| Secondary | Percent Change in Observable Focal-onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period | End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization | During the study, participants kept diaries to record daily seizure activity. The percentage of participants who experienced a 50 % or greater reduction in seizure frequency per 28 days relative to Baseline (responders) was assessed. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Log-transformed Observable Focal Onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period | From Baseline over the 12 Week Maintenance Period | The Full Analysis Set (FAS) consisted of all study participants in the RS who were administered at least 1 dose or a partial dose of IMP and had Baseline and at least 1 post-Baseline seizure frequency data during the 16-week Treatment Period. | loge seizures per 28 days | LEAST_SQUARES_MEAN |
| SECONDARY | 75 % Responder Rate Over the 12 Week Maintenance Period | End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization | The Full Analysis Set (FAS) consisted of all study participants in the RS who were administered at least 1 dose or a partial dose of IMP and had Baseline and at least 1 post-Baseline seizure frequency data during the 16-week Treatment Period. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject and/or Caregiver or Observed by the Investigator During the Entire Study | From Baseline until Safety Follow-Up (up to Week 23) | The Safety Set consisted of all study participants who were administered at least 1 dose or a partial dose of IMP. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study Withdrawal | From Baseline until Safety Follow-Up (up to Week 23) | The Safety Set consisted of all study participants who were administered at least 1 dose or a partial dose of IMP. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) During the Entire Study | From Baseline until Safety Follow-Up (up to Week 23) | The Safety Set consisted of all study participants who were administered at least 1 dose or a partial dose of IMP. | percentage of participants | NUMBER |
| SECONDARY | 50 % Responder Rate Over the 12 Week Maintenance Period | End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization | The Full Analysis Set (FAS) consisted of all study participants in the RS who were administered at least 1 dose or a partial dose of IMP and had Baseline and at least 1 post-Baseline seizure frequency data during the 16-week Treatment Period. | percentage of participants | NUMBER |
| SECONDARY | Percent Change in Observable Focal-onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period | End of Maintenance Period (Week 16) following 3 Weeks of titration and 1 Week stabilization | The Full Analysis Set (FAS) consisted of all study participants in the RS who were administered at least 1 dose or a partial dose of IMP and had Baseline and at least 1 post-Baseline seizure frequency data during the 16-week Treatment Period. | percent change | MEAN |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Log-transformed Observable Focal Onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period | Placebo (FAS) | -0.27585 | 95% Confidence Interval -0.44311 to -0.10858 | loge seizures per 28 days | |
| Change in Log-transformed Observable Focal Onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period | Padsevonil 50mg BID (FAS) | -0.46424 | 95% Confidence Interval -0.63276 to -0.29573 | loge seizures per 28 days | |
| Change in Log-transformed Observable Focal Onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period | Padsevonil 100mg BID (FAS) | -0.48804 | 95% Confidence Interval -0.65436 to -0.32172 | loge seizures per 28 days | |
| Change in Log-transformed Observable Focal Onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period | Padsevonil 200mg BID (FAS) | -0.48960 | 95% Confidence Interval -0.65734 to -0.32187 | loge seizures per 28 days | |
| Change in Log-transformed Observable Focal Onset Seizure Frequency From Baseline Over the 12 Week Maintenance Period | Padsevonil 400mg BID (FAS) | -0.40831 | 95% Confidence Interval -0.57485 to -0.24177 | loge seizures per 28 days | |
| 75 % Responder Rate Over the 12 Week Maintenance Period | Placebo (FAS) | 6.2 | percentage of participants | ||
| 75 % Responder Rate Over the 12 Week Maintenance Period | Padsevonil 50mg BID (FAS) | 13.8 | percentage of participants | ||
| 75 % Responder Rate Over the 12 Week Maintenance Period | Padsevonil 100mg BID (FAS) | 12.2 | percentage of participants | ||
| 75 % Responder Rate Over the 12 Week Maintenance Period | Padsevonil 200mg BID (FAS) | 11.1 | percentage of participants | ||
| 75 % Responder Rate Over the 12 Week Maintenance Period | Padsevonil 400mg BID (FAS) | 16.0 | percentage of participants |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow65
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period: Wk0-16 | STARTED | Placebo | 83 | |
| Treatment Period: Wk0-16 | STARTED | Padsevonil 50mg BID | 81 | |
| Treatment Period: Wk0-16 | STARTED | Padsevonil 100mg BID | 83 | |
| Treatment Period: Wk0-16 | STARTED | Padsevonil 200mg BID | 82 | |
| Treatment Period: Wk0-16 | STARTED | Padsevonil 400mg BID | 82 | |
| Treatment Period: Wk0-16 | Completed Titration and Stabilization | Placebo | 78 | |
| Treatment Period: Wk0-16 | Completed Titration and Stabilization | Padsevonil 50mg BID | 72 | |
| Treatment Period: Wk0-16 | Completed Titration and Stabilization | Padsevonil 100mg BID | 71 | |
| Treatment Period: Wk0-16 | Completed Titration and Stabilization | Padsevonil 200mg BID | 68 | |
| Treatment Period: Wk0-16 | Completed Titration and Stabilization | Padsevonil 400mg BID | 65 |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 participant flowAdverse events660
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 | Vertigo | Ear and labyrinth disorders | Placebo Treatment Period (SS) | 7 | 83 | 7 |
| other | Vertigo | Ear and labyrinth disorders | Padsevonil 50mg BID Treatment Period (SS) | 3 | 81 | 3 |
| other | Vertigo | Ear and labyrinth disorders | Padsevonil 100mg BID Treatment Period (SS) | 2 | 83 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Padsevonil 200mg BID Treatment Period (SS) | 3 | 82 | 3 |
| other | Vertigo | Ear and labyrinth disorders | Padsevonil 400mg BID Treatment Period (SS) | 4 | 81 | 5 |
| other | Vertigo | Ear and labyrinth disorders | Placebo Conversion Period (SS) | 1 | 69 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Padsevonil 50mg BID Conversion Period (SS) | 0 | 64 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Padsevonil 100mg BID Conversion Period (SS) | 0 | 66 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Padsevonil 200mg BID Conversion Period (SS) | 0 | 55 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Padsevonil 400mg BID Conversion Period (SS) | 0 | 57 | 0 |
1 to 10 of 660Source ClinicalTrials.gov
See all 660 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Treatment Period (SS) | 0 | 83 |
| Total, all-cause mortality | Padsevonil 50mg BID Treatment Period (SS) | 0 | 81 |
| Total, all-cause mortality | Padsevonil 100mg BID Treatment Period (SS) | 0 | 83 |
| Total, all-cause mortality | Padsevonil 200mg BID Treatment Period (SS) | 0 | 82 |
| Total, all-cause mortality | Padsevonil 400mg BID Treatment Period (SS) | 0 | 81 |
| Total, all-cause mortality | Placebo Conversion Period (SS) | 0 | 69 |
| Total, all-cause mortality | Padsevonil 50mg BID Conversion Period (SS) | 0 | 64 |
| Total, all-cause mortality | Padsevonil 100mg BID Conversion Period (SS) | 0 | 66 |
| Total, all-cause mortality | Padsevonil 200mg BID Conversion Period (SS) | 0 | 55 |
| Total, all-cause mortality | Padsevonil 400mg BID Conversion Period (SS) | 0 | 57 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT03373383
GET https://conductscience.org/api/trials/v1/NCT03373383/results?page=2