Scoliosis in patients with cerebral palsy MedDRA version: 9.1 Level: LLT Classification code 10039722 Term: Scoliosis
Conditions
Interventions
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 Standardi
Sponsors
University hospital of Hvidovre
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Allergy or toxic reaction to botulinum toksin type A. 2. In case of infection at the injection site. 3. Patients with prior treatment with BTXA within 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To see the radiological effect with Cobb's angle of btxa on scoliosis with intramuscular injection ;Secondary Objective: To see the clinical effect 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. | — |
Countries
Denmark
Outcome results
None listed