NCT02625090

An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of UCB0942 When Used as Adjunctive Therapy for Partial-onset Seizures in Adult Subjects With Highly Drug-resistant Focal Epilepsy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of study EP0073 is to assess the long-term safety, tolerability, and efficacy during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant focal epilepsy. Also, the effects of UCB0942 on the patient's quality of life will be explored.

Detailed description

For those subjects who benefit substantially from UCB0942 in the multicenter, randomized, double-blind, placebo-controlled, parallel group study EP0069, the current open-label extension study EP0073 will provide an opportunity to continue UCB0942 treatment after a careful evaluation of the individual benefit-risk balance and with close monitoring of safety, tolerability and efficacy of long-term study treatment.

Conditions

• Highly Drug-resistant Focal Epilepsy

Interventions

Type	Name	Description
DRUG	UCB0942	* Active Substance: UCB0942 * Pharmaceutical form: Film-coated tablet * Concentration: 25 mg, 100 mg or 200 mg * Route of Administration: oral

Timeline

• Start date: 2015-12-03
• Primary completion: 2020-11-24
• Completion: 2020-11-24
• First posted: 2015-12-09
• Last updated: 2022-03-09
• Results posted: 2022-01-31

Locations

15 sites across 6 countries: Belgium, Bulgaria, Germany, Hungary, Netherlands, Spain