臨床研究等提出・公開システム

Date of registration	Sept. 09, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080220856

Scientific Title	Post-marketing clinical study of Topina tablets in patients with partial epilepsy (incremental dose comparative study)
Public Title	Post-marketing clinical study of Topina tablets

Completion Date or Terminated date
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
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
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Kyowa Hakko Kirin Co., Ltd.
	Address	clinical.info@kyowa-kirin.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		180
Study Type		Interventional
Study Design	Study Design	Double-blind comparative study
Study Design	Objective
Phase		4
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who continue the treatment of one or more antiepileptic drugs with same usage and dosage except Topina tablets Patients who experience one or more partial seizures in every four weeks regardless of the treatment of antiepileptic drugs except Topina tablets
	Exclusion Criteria
	Minimum Age	18age old over
	Maximum Age	64age old under
	Gender	Both
Health Condition or Problem Studied		Partial epilepsy
Intervention(s)		investigational material(s) Generic name etc : Topina tablets (INN:topiramate) INN of investigational material : Therapeutic category code : 113 Antiepileptics Dosage and Administration for Investigational material : Orally twice daily administration for 12 weeks
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety
Secondary Outcome		Efficacy

Primary Sponsor	Kyowa Hakko Kirin Co., Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-090887
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	Mar. 01, 2013	Detail	Changes
9	Aug. 28, 2012	Detail	Changes
8	Aug. 28, 2012	Detail	Changes
7	Dec. 02, 2010	Detail	Changes
6	Sept. 15, 2010	Detail	Changes
5	Sept. 15, 2010	Detail	Changes
4	June. 14, 2010	Detail	Changes
3	June. 14, 2010	Detail	Changes
2	Sept. 09, 2009	Detail	Changes
1	Sept. 09, 2009	Detail

List of change history