18 and older, any sex, with Drug-Resistant Epilepsy or Focal-Onset Seizures. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Log-transformed Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance PeriodPrimary· From Baseline over the 12 Week Maintenance Period (up to Week 16)
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 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
Group
Value
95% CI
Placebo (FAS)
-0.41
-0.6133 – -0.2025
Padsevonil 100 mg BID (FAS)
-0.35
-0.54906 – -0.15705
Padsevonil 200 mg BID (FAS)
-0.47
-0.67559 – -0.27382
Padsevonil 400 mg BID (FAS)
-0.47
-0.67267 – -0.27361
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)Primary· 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. A TEAE was defined as any event not present before the initiation of the first dose of study treatment or any unresolved event already present before initiation of the first dose that worsened in intensity following exposure to the treatment.
Group
Value
95% CI
Placebo (SS)
69.1
Padsevonil 100 mg BID (SS)
83.3
Padsevonil 200 mg BID (SS)
78.9
Padsevonil 400 mg BID (SS)
84.7
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Study WithdrawalPrimary· 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. A TEAE was defined as any event not present before the initiation of the first dose of study treatment or any unresolved event already present before initiation of the first dose that worsened in intensity following exposure to the treatment.
Group
Value
95% CI
Placebo (SS)
7.3
Padsevonil 100 mg BID (SS)
10.0
Padsevonil 200 mg BID (SS)
10.5
Padsevonil 400 mg BID (SS)
20.3
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)Primary· 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 as 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. A TEAE was defined as any event not present before the initiation of the first dose of study treatment or an
Group
Value
95% CI
Placebo (SS)
9.1
Padsevonil 100 mg BID (SS)
3.3
Padsevonil 200 mg BID (SS)
1.8
Padsevonil 400 mg BID (SS)
10.2
75% Responder Rate From Baseline Over the 12-week Maintenance PeriodSecondary· From Baseline over the 12 Week Maintenance Period (up to Week 16)
The 75 % responder rate, where a responder was a participant experiencing a ≥75 % reduction in observable focal-onset seizure frequency from Baseline, over the 12-Week Maintenance Period.
Group
Value
95% CI
Placebo (FAS)
13.0
Padsevonil 100 mg BID (FAS)
15.3
Padsevonil 200 mg BID (FAS)
12.5
Padsevonil 400 mg BID (FAS)
14.3
50% Responder Rate From Baseline Over the 12-week Maintenance PeriodSecondary· From Baseline over the 12 Week Maintenance Period (up to Week 16)
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.
Group
Value
95% CI
Placebo (FAS)
27.8
Padsevonil 100 mg BID (FAS)
35.6
Padsevonil 200 mg BID (FAS)
33.9
Padsevonil 400 mg BID (FAS)
42.9
Percent Change in Observable Focal-onset Seizure Frequency From Baseline Over the 12-week Maintenance PeriodSecondary· From Baseline over the 12 Week Maintenance Period (up to Week 16)
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) were assessed.
Group
Value
95% CI
Placebo (FAS)
22.34
± 44.56
Padsevonil 100 mg BID (FAS)
11.72
± 81.52
Padsevonil 200 mg BID (FAS)
30.29
± 39.58
Padsevonil 400 mg BID (FAS)
22.41
± 62.80
Adverse events — posted to ClinicalTrials.gov
Time frame: TEAEs were collected from Baseline until Safety Follow-Up (up to Week 23).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of the study is to evaluate the efficacy, safety and tolerability of the 3 selected dose regimens of padsevonil (PSL) administered concomitantly with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04136444 — A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function
· Phase 1
· terminated
NCT04126343 — A Study to Test the Cardiac Effects of Padsevonil in Healthy Study Participants
· Phase 1
· terminated
NCT04131517 — A Study to Test the Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants
· Phase 1
· terminated
NCT04075409 — A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants
· Phase 1
· completed
NCT04039919 — A Study to Test the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability of Padsevonil in Healthy Study Participan
· Phase 1
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UCB Biopharma SRL
Last refreshed: 21 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03739840.