NCT01728077

Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects With Epilepsy

An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy Phase 3b

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: UCB Pharma SA · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life and to explore the direct medical resource use for BRV (for subjects entering N01372 from a study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of 200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.

Detailed description

Flexible dosing up to 200 mg/day, twice daily (10, 25 and 50 mg oral film-coated tablets). The study will continue until either regulatory approval of BRV has been granted by any Health Authority in an indication of adjunctive treatment of Epilepsy, or until the Sponsor decides to close the study, or until the BRV development is stopped by the Sponsor.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Brivaracetam	Flexible dosing, can up and down-titrate as needed.

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2012-11-16
• Last updated: 2018-07-11
• Results posted: 2017-08-02

Locations

10 sites across 4 countries: United States, France, Germany, Spain