Conditions: Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 370
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age 2-17 years) long-term with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: IncobotulinumtoxinA (16-20 Units per kg body weight)
Intervention descriptions: intervention 1: Active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total dose per injection cycle: up to 500 units; Mode of administration: intramuscular injection into spastic muscles.

Protocol document: