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

A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam as Replacement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: UCB Biopharma S.P.R.L. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Partial Seizures With or Without Secondary Generalization
• Epilepsy

Interventions

Type	Name	Description
DRUG	Brivaracetam	* Pharmaceutical form: Solution for injection * Concentration: 10 mg/ml * Route of administration: Intravenous injection

Timeline

• Start date: 2019-01-04
• Primary completion: 2021-03-27
• Completion: 2021-03-27
• First posted: 2018-09-26
• Last updated: 2021-04-13

Locations

9 sites across 1 country: Japan