臨床研究等提出・公開システム

Date of registration	April. 20, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221773

Scientific Title	Phase 3 clinical study of RM-003 in patients with homocystinuria
Public Title

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	ReqMed Company, Ltd.
	Address	Pharmaceutical & Business Development
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	ReqMed Company, Ltd.
	Address	betaine@reqmed.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		8
Study Type		Interventional
Study Design	Study Design	Non-randomized, unblinded, uncontrolled, multicenter study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Homocystinuria, described as the following cases - cystathionine beta-synthase deficiency(CBS) - 5,10-methylenetetrahydrofolate reductase deficiency - defects in cobalamin metabolism
	Exclusion Criteria
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Homocystinuria, described as the following cases; cystathionine beta-synthase deficiency(CBS), 5,10-methylenetetrahydrofolate reductase deficiency, defects in cobalamin metabolism
Intervention(s)		investigational material(s) Generic name etc : RM-003 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Two times a day, oral administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Plasma total homocysteine levels at the end of the treatment
Secondary Outcome		Plasma total homocysteine levels at each visit of the treatment Plasma homocystine levels at the end of the treatment

Primary Sponsor	ReqMed Company, 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-121815
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Dec. 11, 2015	Detail	Changes
5	Dec. 11, 2015	Detail	Changes
4	June. 27, 2013	Detail	Changes
3	June. 27, 2013	Detail	Changes
2	April. 23, 2012	Detail	Changes
1	April. 20, 2012	Detail

List of change history