NCT03370120

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

An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Padsevonil	* Pharmaceutical Form: film-coated tablet * Route of Administration: Oral use

Timeline

• Start date: 2018-08-27
• Primary completion: 2020-12-11
• Completion: 2020-12-11
• First posted: 2017-12-12
• Last updated: 2021-12-29
• Results posted: 2021-12-29

Locations

156 sites across 27 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

Regulatory

• FDA-regulated drug study