Lower limb spasticity
Conditions
Brief summary
Change from baseline in derived MAS ankle score (knee extended) at Weeks 4 to 6 (using a value modelled from the actual values measured at Week 4 [V3] and Week 6 [V4]), GICS assessed by physician at Week 4 to 6 (using a value modelled from the actual values measured at Week 4 [V3] and Week 6 [V4]) (co-primary for US regulatory authority only, otherwise secondary)., Primary safety variable: • Occurrence of treatment emergent adverse events [TEAEs] in Main Period.
Detailed description
Key secondary efficacy variable: Change from Study Baseline in Goal Attainment Scale [GAS] at Week 6 (V4), GICS assessed by subject at Week 4 (V3) to Week 6 (V4), GICS assessed by caregiver at Week 4 (V3) to Week 6 (V4).
Interventions
DRUGXEOMIN 200 unidades polvo para solución inyectable
DRUGXEOMEEN 200 unités poudre pour solution injectable
DRUGXEOMEEN 200 eenheden poeder voor oplossing voor injectie
DRUGXEOMIN
DRUG200 unità
DRUGXEOMIN 200 jednotek prášek pro injekční roztok
DRUGpoudre pour solution injectable
DRUG200 jednostek
DRUGXEOMIN 200 Einheiten Pulver zur Herstellung einer Injektionslösung
DRUGXEOMIN 200 jednotiek prášok na injekčný roztok
DRUGXEOMIN 200 egység por oldatos injekcióhoz
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in derived MAS ankle score (knee extended) at Weeks 4 to 6 (using a value modelled from the actual values measured at Week 4 [V3] and Week 6 [V4]), GICS assessed by physician at Week 4 to 6 (using a value modelled from the actual values measured at Week 4 [V3] and Week 6 [V4]) (co-primary for US regulatory authority only, otherwise secondary)., Primary safety variable: • Occurrence of treatment emergent adverse events [TEAEs] in Main Period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary efficacy variable: Change from Study Baseline in Goal Attainment Scale [GAS] at Week 6 (V4), GICS assessed by subject at Week 4 (V3) to Week 6 (V4), GICS assessed by caregiver at Week 4 (V3) to Week 6 (V4). | — |
Countries
Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Slovakia, Spain
Outcome results
None listed