JPRN-jRCT1080220031
Unknown
Phase 4
Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- 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
- Sponsor
- DAIICHI SANKYO COMPANY, LIMITED
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- Not provided
Outcomes
Primary Outcomes
Not specified
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