drugset / Trial / NCT03685630

A Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam (BRV) as Replacement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

NCT03685630

Phase 3 Completed 10 enrolled UCB Biopharma S.P.R.L.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to evaluate the safety and tolerability of intravenous (iv) brivaracetam (BRV) as adjunctive therapy administered as a replacement for oral BRV at doses ranging from BRV 50 mg/day to 200 mg/day in Japanese subjects \>=16 years of age with partial seizures with or without secondary generalization and to evaluate the partial seizure frequency after switching from oral administration to iv BRV.

Timeline

Start
2019-01-04
Primary completion
2021-03-27
Completion
2021-03-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Brivaracetam Small molecule 50 mg Intravenous
Subject Brivaracetam Small molecule 200 mg Intravenous

Indications