CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 411 enrolled
Drug / intervention
Padsevonil +1 moredrug
Likely dose
Padsevonil in different dosages (dose-finding study; specific dose not stated)AI-extracted
Key inclusion· 4
  • ✓Focal epilepsy diagnosis per 1989 ILAE criteria for at least 3 years before study entry
  • ✓Failed to achieve seizure control with 4 or more tolerated and appropriately chosen prior antiepileptic drugs (AED), individually optimized for dose and duration
  • ✓Average of ≥4 spontaneous and observable focal seizures (types IA1, IB, or IC) per month
  • ✓Currently on individualized and stable dose of 1–3 AEDs for ≥8 weeks prior to screening, with or without VNS or other neurostimulation
Key exclusion· 9
  • ✕History of or signs of generalized or combined generalized and focal epilepsy
  • ✕Cluster seizures that are uncountable in the 8 weeks before entry and during 4-week prospective baseline
  • ✕Current treatment with carbamazepine, phenytoin, primidone, or phenobarbital
  • ✕Current use of potent CYP3A4 or CYP2C19 inducers or inhibitors (prescription, nonprescription, dietary, or herbal) for <2 weeks or <5 half-lives prior to baseline

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03373383
NCT03373383Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy

UCB Biopharma S.P.R.L.·interventional·Posted Dec 14, 2017·Updated Dec 19, 2023

In Brief

A Phase 2 clinical trial evaluating Padsevonil and Placebo for Drug-resistant Epilepsy and Focal-Onset Seizures. Completed, enrolled 411 participants across 148 sites in 19 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug-resistant Epilepsy, Focal-Onset Seizures
CountriesAustralia, Belgium, Bulgaria, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Lithuania, Mexico, Poland, Portugal, Slovakia, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 14, 2017
Enrollment StartFeb 12, 2018
Primary CompletionJan 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.5 years ago

Interventions

Padsevonildrug

Padsevonil in different dosages.

Placeboother

Placebo will be provided matching Padsevonil.