Prospective, randomised, doubleblind, placebo controlled trial on changes in acetylcholine receptor antibody titers in autoimmune myasthenia gravis after influenza vaccination EudraCT-Nr. 2006-004374-27
Phase 2
- Conditions
- G70.0Myasthenia gravis
- Registration Number
- DRKS00000360
- Lead Sponsor
- Philipps-Universität MarburgKoordinierungszentrum für Klinische Studien (KKS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
written informed consent
age at least 18 years
age of 80 years maximum
diagnosis of myasthenia gravis according the guideline of the German Neurological Society
positve anti-AChR abs
clinically stable for at least 4 months
Exclusion Criteria
any vaccination within 9 months prior to study entry
history of severe heart disease
cardiac arrythmia
History of cancer
acute infection at screening or Visit 1
allergy against chicken protein
History of severe vaccination reaction
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method relative changes in % of the AChR-ab titer within three months after anti-Influenza vaccination
- Secondary Outcome Measures
Name Time Method vaccination success, changes in pyridostigmine and/or immunosuppresants dosage, modified Besinger-/MGFA score to quantify weakness