臨床研究等提出・公開システム

Date of registration	Oct. 18, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221270

Scientific Title	A Safety and Efficacy Extension Study of ONO-4641 in Patients with Relapsing-Remitting Multiple Sclerosis
Public Title	A Safety and Efficacy Extension Study of ONO-4641 in Patients with Relapsing-Remitting Multiple Sclerosis

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	ONO PHARMACEUTICAL CO.,LTD.
	Address	y.tani@ono.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		343
Study Type		Interventional
Study Design	Study Design	dose-blind, randomized
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Completed 26 weeks of double-blind phase of Study ONO-4641POU006
	Exclusion Criteria	Presence of any dermatological abnormalities during Study ONO-4641POU006 that could increase the risk of the patient developing a skin cancer.
	Minimum Age	18age old over
	Maximum Age	55age old under
	Gender	Both
Health Condition or Problem Studied		Relapsing-Remitting Multiple Sclerosis
Intervention(s)		investigational material(s) Generic name etc : ONO-4641 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Patients will receive an oral tablet (0.05, 0.1 or 0.15 mg)once per day at about the same time.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		the long-term safety and tolerability of ONO-4641
Secondary Outcome		the number of Gd-enhanced lesions, lesion volume, and brain volume obtained by MRI

Primary Sponsor	ONO PHARMACEUTICAL CO.,LTD.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

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

Secondary ID No.	JapicCTI-101307
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
12	Dec. 17, 2018	(this page)	Changes
11	May. 23, 2017	Detail	Changes
10	May. 23, 2017	Detail	Changes
9	July. 10, 2013	Detail	Changes
8	July. 10, 2013	Detail	Changes
7	July. 02, 2012	Detail	Changes
6	July. 02, 2012	Detail	Changes
5	June. 14, 2011	Detail	Changes
4	June. 14, 2011	Detail	Changes
3	April. 21, 2011	Detail	Changes
2	Oct. 18, 2010	Detail	Changes
1	Oct. 18, 2010	Detail

List of change history