NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-050031

Registered date:06/09/2005

Basic Information

Recruitment status
Health condition(s) or Problem(s) 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
Date of first enrollment
Target sample size
Countries of recruitment
Study typeOBSERVATIONAL
Intervention(s)Intervention name : Baclofen Dosage And administration of the intervention : Intertheacal injection

Outcome(s)

Primary OutcomeSafety, efficacy
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum
Age maximum
GenderBOTH
Include criteriaPatient 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.
Exclude criteria

Related Information

Contact

public contact
Name DAIICHI SANKYO COMPANY, LIMITED Contact for Clinical Trial Information
Address http://www.daiichisankyo.co.jp/contact/index.html
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E-mail
Affiliation
scientific contact
Name
Address
Telephone
E-mail
Affiliation