tilisation of botulinum toxin type A on masticatory muscel hyperactivity in CP.
- Conditions
- Masticatory muscle hyperactivity/bruxism in patients with Cerebral Palsy.MedDRA version: 14.1Level: HLGTClassification code 10028037Term: Movement disorders (incl parkinsonism)System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-004795-19-SE
- Lead Sponsor
- Folktandvården Västra Götaland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Willingness to participate
2. Female and male aged 18 years or older
3. CP with masticatory muscle hyperactivity/bruxism
4. Obvious tooth wear
5. Capabillity to decide
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Inability to understand the study and complete the questionnaire
2. Patients with known hypersensitivity to Botox
3. Patients with any infection in the injection site
4. Treatment with BTX-A injection last month
5. Medication with aminoglycoside antibiotics, spectinomycin and neuromuskular blockers
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