NCT02495844

A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

Double-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety/Tolerability, and Pharmacokinetic Profile of UCB0942 in Adults With Highly Drug-resistant Focal Epilepsy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: UCB Biopharma S.P.R.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess the efficacy, safety, and tolerability of the investigational drug UCB0942in adult subjects with drug-resistant focal epilepsy across multiple centers in Europe.

Detailed description

The study will include a Screening Visit, a Prospective Outpatient Baseline Period (2 to 3 weeks), an Inpatient Period (3 weeks), an Outpatient Period (8 weeks of treatment and 2 weeks of taper), and a Safety Follow-Up Period (4 weeks). The total study duration after screening will be 19 to 20 weeks. Approximately 6 months after the last visit subjects will be asked to return for an additional visit.

Conditions

• Highly Drug-resistant Focal Epilepsy

Interventions

Type	Name	Description
DRUG	UCB0942	Active substance: UCB0942 Pharmaceutical form: Film-coated tablet Concentration: 200 mg Route of Administration: Oral use
DRUG	UCB0942	Active substance: UCB0942 Pharmaceutical form: Film-coated tablet Concentration: 100 mg Route of Administration: Oral use
DRUG	Placebo	Pharmaceutical form: Film-coated tablet Route of administration: Oral use

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-02-01
• Completion: 2017-07-01
• First posted: 2015-07-13
• Last updated: 2019-02-05
• Results posted: 2019-02-05

Locations

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