Conditions: Post-stroke Spasticity of the Upper Limb
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 317
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.

Detailed description:
The study consists of a randomized, double-blind, placebo-controlled, parallel-group, single-dose main period followed by an open-label, non-controlled, repeated-dose extension period (Open-Label Extension Period - OLEX).

Arms:
arm 1: IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment arm 2: Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment

Interventions: intervention 1: IncobotulinumtoxinA (400 Units) intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection intervention 2: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

Protocol document: