NIPH Clinical Trials Search

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	06/09/2005
Target sample size
Countries of recruitment
Study type	Observational
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

Outcome(s)

Primary Outcome	Safety, efficacy
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude criteria