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CompletedNo phase

Assessment of Long-term Clinical Response to BoNT in Cervical Dystonia

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Trial details

Who runs it
Merz Therapeutics GmbH
Trial code
NCT05884528
Record updated
21 August 2024
Original description
The goal of this retrospective, international, multi-center chart abstraction is to learn about the long-term impact of product-specific immunogenicity-related factors in different botulinum neurotoxin type A formulations in patients suffering from cervical dystonia. The main question it aims to answer is:Read full original descriptionShow less

Assessment of Long-term Clinical Response to BoNT in Cervical Dystonia - Real-world Evidence of LongevitY of Botulinum Toxin in Cervical Dystonia

The goal of this retrospective, international, multi-center chart abstraction is to learn about the long-term impact of product-specific immunogenicity-related factors in different botulinum neurotoxin type A formulations in patients suffering from cervical dystonia. The main question it aims to answer is:

Do complex-containing (CC) botulinum toxin formulations impact the long-term clinical outcome in cervical dystonia patients compared to a complex-free (CF) formulation?

Researchers will compare differences observed in years 2 and 7 between two toxin groups, i.e., botulinum neurotoxins type A containing complexing proteins (CC) and without complexing proteins (CF).

Clinical diagnosis of cervical dystonia; Adults (m/f) 18-64 years of age at start of BoNT/A treatment; Patient's written informed consent if required by local and/or national law.

ClinicalTrials.gov NCT05884528