臨床研究等提出・公開システム

Date of registration	Mar. 25, 2014
Last modified on	Nov. 05, 2019
Trial ID	jRCT2080222434

Scientific Title	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
Public Title	Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy (BRITE)

Completion Date or Terminated date	June. 28, 2018
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	-
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	UCB Japan Co., Ltd.
	Address	8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo
	Phone Number	-
	E-mail Address	CTR_SCC_UCBJapan＠UCB.com

Contact for Public Queries	Name
	Contact Name for Public Queries	UCB Japan Co., Ltd.
	Address	8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo
	Phone Number	-
	E-mail Address	CTR_SCC_UCBJapan＠UCB.com

Recruitment Status	completed

Date of First Enrolment		Mar. 18, 2014
Target Sample Size		767
Study Type		Interventional
Study Design	Study Design	open-label, multicenter, follow-up study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	- Subject completed the Treatment Period of N01358 or the evaluation period of N01258 - Subject for whom the Investigator believes a reasonable benefit from the long term administration of Brivaracetam 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 studies - 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
	Minimum Age	16age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Epilepsy and epilepsy syndrome
Intervention(s)		investigational material(s) Generic name etc : ucb 34714 INN of investigational material : Brivaracetam Therapeutic category code : 113 Antiepileptics Dosage and Administration for Investigational material : control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety - Partial onset seizure (type I) frequency per 28 days during the Evaluation Period - Percent reduction in partial onset seizures (type I) frequency per 28 days from Baseline of the previous study to the Evaluation Period - Responder rate in partial onset seizure (type I) frequency over the Evaluation Period
Secondary Outcome		safety efficacy - Partial onset seizure (type I) frequency per 28 days during the Evaluation Period - Percent reduction in partial onset seizures (type I) frequency per 28 days from Baseline of the previous study to the Evaluation Period - Responder rate in partial onset seizure (type I) frequency over the Evaluation Period

Primary Sponsor	UCB Japan Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	NHO Shizuoka Institute of Epilepsy and Neurological Disorders IRB
Address of IRB	Urushiyama 886, Aoi-ku, Shizuoka 420-8688, Japan
Phone Number of IRB	+81-54-245-5446
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	June. 28, 2013

Secondary ID No.	NCT01339559
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-142484
Name of Other Registries

Countries / Regions of Recruitment	Japan/North America/Europe

History of Changes

No	Publication date
3	Nov. 05, 2019	(this page)	Changes
2	July. 10, 2015	Detail	Changes
1	Mar. 25, 2014	Detail

List of change history