Can local botulinum toxin improve swallowing difficulties in persons with msucle disease?
Phase 1
- Conditions
- Oculopharyngesl muscle dystrophy, inclusion body myositisMedDRA version: 18.1 Level: LLT Classification code 10019897 Term: Hereditary progressive muscular dystrophy System Organ Class: 100000004850Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2014-002210-23-DK
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
•18-80 years old
•IBM or OPMD
•Dysphagia
•Signed informed consent
•Stable dosing of immunemodulation
•No other important reason for dysphagia
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
Involvement in other trial last 30 days
Medication or disease incompatible with botox
Botox allergy
Botox treatment within 6 mth
Pregnant or lactating
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate if local intramuscular botulinum toxin can alleviate myopahtic dysphagia;Secondary Objective: None;Primary end point(s): Improvement in dysphagia;Timepoint(s) of evaluation of this end point: 4 and 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): none;Timepoint(s) of evaluation of this end point: 0