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)

Phase 3

Completed

• Conditions: Focal Epilepsy

• Registration Number: CTRI/2011/07/001898
• Lead Sponsor: SCHWARZ BIOSCIENCES INC A Member of the UCB Group of Companies

Brief Summary

UCB is developing BRV(Brivaracetam) as an adjunctive antiepileptic treatment in subjects 16 years and older suffering from focal epilepsy. N01379 will give subjects who have completed N01358 the opportunity to access BRV (Brivaracetam)  under the present protocol. N01358 is an adequate and well-controlled study to provide additional data confirming the efficacy and safety of BRV (Brivaracetam) as an AED (Anti Epiletic Drug) in adults (more than or equal to16 years) with refractory POS whether or not secondarily generalized. N01379 will explore the long-term safety and efficacy of BRV (Brivaracetam) in subjects with POS (Partial Onset Seizures) whether or not secondarily generalized while providing access to BRV (Brivaracetam) for subjects who may benefit from open-label treatment with BRV (Brivaracetam) .

Study is globally in recruitment. In India recruitment has started.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-23
• Last Update Posted: 2018-06-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 900

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The secondary objective is to evaluate the maintenance of efficacy of	BRV over time.

Trial Locations

Locations (6)

Apollo Speciality Hospitals; 🇮🇳 Madurai, TAMIL NADU, India

Krishna Institute of Medical Sciences Ltd,; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

M.S.Ramaiah Memorial Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Neurocare; 🇮🇳 Nashik, MAHARASHTRA, India

PD Hinduja National Hospital and Medical Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Seth G. S. Medical College, K.E.M. Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Apollo Speciality Hospitals

🇮🇳Madurai, TAMIL NADU, India

Dr Salvadeeswaran Meenakshi Sudaram

Principal investigator

919842142999

drsundarsms@gmail.com