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A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy

NCT03739840 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2022-12-21

Study results available
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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.

Conditions

  • Drug-Resistant Epilepsy
  • Focal-Onset Seizures

Interventions

DRUG

Padsevonil

Padsevonil in different dosages.

DRUG

Placebo

Placebo will be provided matching padsevonil.

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-06
Primary Completion
2020-09-28
Completion
2020-09-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Bosnia and Herzegovina
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Japan
  • Norway
  • Poland
  • Portugal
  • Romania
  • Serbia
  • Slovakia
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03739840 on ClinicalTrials.gov