[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
Conditions
Interventions
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 I
Sponsors
DAIICHI SANKYO COMPANY, LIMITED
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, efficacy | — |
Outcome results
None listed