Conditions: Spasticity of the Upper and Lower Limb Due to Cerebral Causes
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 155
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.

Detailed description:
A dose-titration approach will be used over three injection cycles, with a flexible observation period after injections of 12-16 weeks and a total duration of up to 48 weeks. Cycle 1 and 2: upper and/or lower limb to be treated; Cycle 3: upper and lower limb to be treated.

Arms:
arm 1: IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection

Interventions: intervention 1: IncobotulinumtoxinA
Intervention descriptions: intervention 1: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.

For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: intramuscular injection.

Protocol document: