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

NCT03370120 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2021-12-29

Study results available
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Summary

The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.

Conditions

  • Drug-Resistant Epilepsy
  • Focal-Onset Seizures

Interventions

DRUG

Padsevonil

* Pharmaceutical Form: film-coated tablet * Route of Administration: Oral use

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-27
Primary Completion
2020-12-11
Completion
2020-12-11
FDA Drug
Yes

Countries

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

Study Locations

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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 NCT03370120 on ClinicalTrials.gov