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NCT03373383 · ClinicalTrials.gov registry record · Phase 2
Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
A Phase 2 study, sponsored by UCB Biopharma S.P.R.L..
- Completed
- Registry status
- Phase 2
- Development phase
- 411
- Enrollment target
NCT03373383: Completed Phase 2 study, sponsored by UCB Biopharma S.P.R.L..
NCT03373383 is a Phase 2 study that has completed, run by UCB Biopharma S.P.R.L.. The registered enrollment target is 411 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (209% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03373383, a Phase 2 study, has completed, sponsored by UCB Biopharma S.P.R.L..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 411 participants
- Enrollment target
Study Summary
The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) 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, 28-day adjusted seizure frequency from Baseline with treatment group as the main factor, Ba
Interventions
- OTHER Placebo
- DRUG Padsevonil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 411 participants |
| Start Date | 2018-02-12 |
| Est. Completion | 2020-01-30 |
| Phase | Phase 2 |
What the finished NCT03373383 record still lists
NCT03373383 is an interventional study that assigns participants to a tested intervention. The registered 411 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (209% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03373383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03373383 about?
NCT03373383 is a clinical study titled "Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy". The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.
What is the current status of trial NCT03373383?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 411 participants. The study started on 2018-02-12. Estimated completion is 2020-01-30.
What interventions are being tested in trial NCT03373383?
The interventions under investigation include: Placebo (OTHER), Padsevonil (DRUG).
Who is sponsoring clinical trial NCT03373383?
This trial is sponsored by UCB Biopharma S.P.R.L., which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03373383's enrollment target sits among peer trials
411 93rd of 2000 higher than 1,908 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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