Upper limb spasticity or Lower limb Spasticity
Conditions
Interventions
The investigator injects NT 201 into the patient's tonic muscles.
The treatment period will be up to 36 weeks after the first dose, and the NT 201 will be administered 2 to 4 times.
Sponsors
Tsushima Shohei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients aged 2 or more and less than 15 years at the time of obtaining informed consent (2)Patients who have been diagnosed with upper limb spasticity, lower limb spasticity, or upper and lower limb spasticity and who meet either or both of the following criteria: - Patients who require administration of NT 201 to one or both upper limbs - Patients who require administration of NT 201 to one or both lower limbs (3)Patients who meet the criteria for severity of spasticity at the time of pre-registration examination (4)If patients have previously undergone botulinum toxin treatment, 14 weeks or more have passed since their last botulinum toxin treatment before the pre-registration examination
Exclusion criteria
Exclusion criteria: (1)Patients with fixed contractures in the joints (wrists, elbows, knees, ankles, etc.) where NT 201 will be injected (2)Patients who have not seen any therapeutic effect from previous botulinum toxin treatments (3)Patients with an unhealed fracture at the injection site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Change from baseline in the Modified Ashworth Scale(MAS) score in wrist flexors at 4 weeks after the first injection. -Change from baseline in the Modified Ashworth Scale(MAS) score in planter flexors at 4 weeks after the first injection. | — |
Contacts
Public ContactShohei Tsushima
Teijin Pharma Limited
Outcome results
None listed