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

NCT05884528 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2024-08-21

No results posted yet for this study

Summary

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).

Conditions

  • Cervical Dystonia

Interventions

BIOLOGICAL

CC BoNT/A

Complex-containing BotulinumtoxinA (BoNT/A) formulations

BIOLOGICAL

CF BoNT/A

Complex-free BotulinumtoxinA (BoNT/A) formulation

BIOLOGICAL

CF to CC BoNT/A

Switch from complex-free to complex-containing BoNT/A formulations

BIOLOGICAL

CC to CF BoNT/A

Switch from complex-containing to complex-free BoNT/A formulations

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    collaborator OTHER

  • Merz Therapeutics GmbH

    lead INDUSTRY

Principal Investigators

  • Merz Medical Expert · Merz Therapeutics

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-08
Primary Completion
2024-05-31
Completion
2024-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05884528 on ClinicalTrials.gov