Skolioser hos cerebral parese patienter behandlet med Botulinum toxin A

INTERVENTION: Trade Name: botox Product Name: botox Pharmaceutical Form: Injection* INN or Proposed INN: Botulinumtoksini type A CAS Number: 93384‐43‐1 Other descriptive name: botox Concentration unit: SU Standardised Unit(s) (Deprecated) Concentration type: equal Concentration number: 150 kilodalton‐50 LD (mice) Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use CONDITION: Scoliosis in patients with cerebral palsy ; MedDRA version: 9.1 Level: LLT Classification code 10039722 Term: Scoliosis PRIMARY OUTCOME: Main Objective: To see the radiological effect with Cobb's angle of btxa on scoliosis with intramuscular injection Primary end point(s): 1. Radiographical cobb's angle and nash and moe's measurements.; 2. Clinical evaluation with QOL, GMFM/GMFCS and VAS score. Secondary Objective: To see the clinical effect of btxa on scoliosis with intramuscular injection INCLUSION CRITERIA: 1. Cerebral palsy patients with neuromuscular scoliosis in the age from 2 to 18 years. 2. Need to treat the scoliosis and no prior surgery. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range