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NCT03739840 · ClinicalTrials.gov registry record · Phase 3
A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
A Phase 3 study, sponsored by UCB Biopharma SRL.
- Terminated
- Registry status
- Phase 3
- Development phase
- 232
- Enrollment target
NCT03739840: Clinical Trial Phase 3 study, sponsored by UCB Biopharma SRL.
NCT03739840 is a Phase 3 study that was terminated before completion, run by UCB Biopharma SRL. The registered enrollment target is 232 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03739840, a Phase 3 study, was terminated before completion, sponsored by UCB Biopharma SRL.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 232 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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-trans
Interventions
- DRUG Placebo
- DRUG Padsevonil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2019-03-06 |
| Est. Completion | 2020-09-28 |
| Phase | Phase 3 |
Why NCT03739840 stopped before completion
NCT03739840 is an interventional study that assigns participants to a tested intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03739840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03739840 about?
NCT03739840 is a clinical study titled "A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy". 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...
What is the current status of trial NCT03739840?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 232 participants. The study started on 2019-03-06. Estimated completion is 2020-09-28.
What interventions are being tested in trial NCT03739840?
The interventions under investigation include: Placebo (DRUG), Padsevonil (DRUG).
Who is sponsoring clinical trial NCT03739840?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03739840's enrollment target sits among peer trials
232 1298th of 2000 higher than 701 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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