臨床研究等提出・公開システム

Date of registration	Sept. 06, 2005
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080220031

Scientific Title	Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval)
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
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO COMPANY, LIMITED
	Address	http://www.daiichisankyo.co.jp/contact/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Observational
Study Design	Study Design	multi-center trials
Study Design	Objective
Phase		4
Key inclusion & exclusion criteria	Inclusion Criteria	Patient meeting the criteria for inclusion, who intend to continue the treatment with intrathecal baclofen using the implanted pump system after approval of NDA. The written informed consent by the patients or the legal representative is a must. [Criteria for inclusion] 1) Patient effective to the intrathecal baclofen therapy at the long term safety clinical trial(phase 3), and is judged as no safety issue by the doctor. 2) Patient who can be regularly followed during clinical trial.
	Exclusion Criteria
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		[Spinal cord Origin] Spinal cord Injury, Multiple sclerosis, Spinocerebellar degeneration, Circulatory disorder of the spinal, Ossification of the posterior longitudinal ligament [Cerebral Origin] Cerebral palsy, Traumatic head injury
Intervention(s)		investigational material(s) Generic name etc : Baclofen INN of investigational material : Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : Intertheacal injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety, efficacy
Secondary Outcome

Primary Sponsor	DAIICHI SANKYO COMPANY, LIMITED
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name	None
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-050031
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
13	Dec. 17, 2018	(this page)	Changes
12	Jan. 10, 2012	Detail	Changes
11	Aug. 05, 2011	Detail	Changes
10	Aug. 05, 2011	Detail	Changes
9	Aug. 01, 2011	Detail	Changes
8	Aug. 01, 2011	Detail	Changes
7	April. 01, 2007	Detail	Changes
6	April. 01, 2007	Detail	Changes
5	April. 07, 2006	Detail	Changes
4	April. 07, 2006	Detail	Changes
3	Dec. 21, 2005	Detail	Changes
2	Dec. 02, 2005	Detail	Changes
1	Sept. 06, 2005	Detail

List of change history