Skolioser hos cerebral parese patienter behandlet med Botulinum toxin AInjektioner.
Phase 1
- Conditions
- Scoliosis in patients with cerebral palsyMedDRA version: 9.1Level: LLTClassification code 10039722Term: Scoliosis
- Registration Number
- EUCTR2008-004584-19-DK
- Lead Sponsor
- niversity hospital of Hvidovre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 33
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method