A study to determine that long term safety and efficacy of an anti-epileptic drug Brivaracetam when used in combination with other agents in adult patients with epilepsy or fits (partial onset seizures)

An Open label, Multicentre, Follow up study to evaluate the long term safety and efficacy of Brivaracetam used as adjunctive treatment in subject aged 16 years or older with Epilepsy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/07/001898

Enrollment

900

Registered

2011-07-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Brivaracetam: 10mg, 25mg, 50 mg, 52 weeks, route of administration-oral

Eligibility

Inclusion criteria

Inclusion criteria: Subject completed the Treatment Period of N01358. Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected.

Exclusion criteria

Exclusion criteria: Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core study Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject Poor compliance with the visit schedule or medication intake in the previous BRV study Any medical condition which, in the Investigator?s opinion, warrants exclusion

Design outcomes

Primary

Measure	Time frame
The primary efficacy variable is the POS (type I) seizure frequency standardized to a 28-day duration.Timepoint: This will be summarized by 3-month periods over the Evaluation Period.	—

Secondary

Measure	Time frame
The secondary objective is to evaluate the maintenance of efficacy of BRV over time.Timepoint: 3 months	—

Countries

Austria, Belgium, China, Czech Republic, Germany, Hungary, Israel, Italy, Netherlands, Romania, Singapore, Spain, Taiwan, United Kingdom, United States of America

Contacts

Public ContactJigar Lakhani

Pharmaceutical Research Associates India Pvt. Ltd

ParikhAparna@prahs.com91-2271234107

Outcome results