Assessment of Long-term Clinical Response to BoNT in Cervical Dystonia
Completed
- Conditions
- Cervical Dystonia
- Registration Number
- NCT05884528
- Lead Sponsor
- Merz Therapeutics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 270
Inclusion Criteria
Clinical diagnosis of cervical dystonia<br><br> - Adults (m/f) 18-64 years of age at start of BoNT/A treatment<br><br> - Patient's written informed consent if required by local and/or national law.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with a clinically meaningful change in dose-effect at year 7 compared to reference year 2 between complex-free and complex-containing BoNT/A monotherapy
- Secondary Outcome Measures
Name Time Method Clinical meaningfulness of change in efficacy from baseline (first visit on record) at each visit in years 2, 5, 7, 10 in all treatment groups