Upper limb spasticity (ULS) of any aetiology (in US and France) or post- stroke ULS (in Canada)
Conditions
Brief summary
Rate of TEAEs from injection to 12 weeks
Detailed description
Rate of ADRs, SAEs and AESIs from injection to 12 weeks, Duration of response based on retreatment criteria, Muscle tone assessed by the MAS for finger, wrist and elbow flexors at 1, 4, 10, 12 ± 16, 20, 24 weeks based on PTMG and MAS total score, Perceived function and pain assessed by the DAS at 1, 4, 10, 12 ± 16, 20, 24 weeks based on PTT and DAS total score, PGA of treatment response at 1, 4, 10, 12 ± 16, 20, 24 weeks, QoL, using the SF-12 perceived health score and SQoL-6D at 4 weeks, 12 weeks and at end of each cycle
Interventions
Sponsors
Ipsen Pharma
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of TEAEs from injection to 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of ADRs, SAEs and AESIs from injection to 12 weeks, Duration of response based on retreatment criteria, Muscle tone assessed by the MAS for finger, wrist and elbow flexors at 1, 4, 10, 12 ± 16, 20, 24 weeks based on PTMG and MAS total score, Perceived function and pain assessed by the DAS at 1, 4, 10, 12 ± 16, 20, 24 weeks based on PTT and DAS total score, PGA of treatment response at 1, 4, 10, 12 ± 16, 20, 24 weeks, QoL, using the SF-12 perceived health score and SQoL-6D at 4 weeks, 12 weeks and at end of each cycle | — |
Countries
France
Outcome results
None listed