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)

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2011/07/001898
• Date of registration: 19-07-2011
• Prospective Registration: Yes
• Primary sponsor: SCHWARZ BIOSCIENCES INC A Member of the UCB Group of Companies
• Public title: 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)
• Scientific title: 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
• Date of first enrolment: 23-09-2011
• Target sample size: 900
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2521
• Study type: Interventional
• Study design: Non-randomized, Multiple Arm Trial; Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Dr Aparna Parikh
• Affiliation: Pharmaceutical Research Associates India Pvt. Ltd

• Name: Jigar Lakhani
• Affiliation: Pharmaceutical Research Associates India Pvt. Ltd

Key inclusion & exclusion 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: 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





Age minimum:
Age maximum:
Gender:

Intervention(s)

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

Primary Outcome(s)

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 Outcome(s)

The secondary objective is to evaluate the maintenance of efficacy of

BRV over time.Timepoint: 3 months

Secondary ID(s)

NCT01339559, Protocol Amendment 3 dated 15 May 2015

N01379

Source(s) of Monetary Support

UCB BIOSCIENCES, INC., 8010 Arco Corporate Drive, Suite 100 Raleigh, NC 27617 UNITED STATES

Secondary Sponsor(s)

PRA International

Ethics review

Status: Approved
Approval date: 11/04/2011
Contact:

Shatabdi Hospital Ethics Committee

Status: Approved
Approval date: 30/04/2011
Contact:

Institutional Ethics Committee- KIIMS

Status: Approved
Approval date: 20/05/2011
Contact:

Ethical Review Board

Status: Approved
Approval date: 28/05/2011
Contact:

Apollo hospitals

Status: Approved
Approval date: 15/07/2011
Contact:

Clinical Research and Ethics committee

Status: Approved
Approval date: 23/08/2011
Contact:

Ethics committee for Research on Human subjects