Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval)
Phase 4
- Conditions
- [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
- Registration Number
- JPRN-jRCT1080220031
- Lead Sponsor
- DAIICHI SANKYO COMPANY, LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, efficacy
- Secondary Outcome Measures
Name Time Method