Conditions: Cerebral Palsy Muscle Spasticity Children
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 241
Healthy volunteers: no

Brief summary:
The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.

Detailed description:

Arms:
arm 1: 10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg. arm 2: 15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg. arm 3: Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.

Interventions: intervention 1: Botulinum toxin type A intervention 2: Placebo
Intervention descriptions: intervention 1: I.M. (in the muscle) injection on day 1 of a single treatment cycle. intervention 2: I.M. injection on day 1 of a single treatment cycle.

Protocol document: