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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-08

Study Completion Date

2024-07-31

Brief Summary

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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).

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Detailed Description

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Botulinum neurotoxin type A (BoNT/A) is first-line treatment in patients suffering from cervical dystonia. Effect of BoNT/A is temporary and must be repeated to maintain clinical effect. As for all biologics, repeated treatment bears the risk of activating an immune response due to the immunogenic nature of foreign proteins. Clinical signs of a potential immune response are reduced, or loss of efficacy, decreased duration of effect, and the need of a dose increase to maintain effect. Due to the different degree of purity and protein content, it is reasonable to assume that commercial BoNT/A formulations differ in immunogenic properties.

Pivotal clinical trials and monocentric real-world studies demonstrated an increased incidence of neutralizing antibodies (NAbs) and NAb-associated partial or complete secondary non-response. However, the clinical relevance of potential immunogenicity-related mechanisms has not been demonstrated in a larger multicentric cohort in a real-world setting. This chart abstraction is designed to address this gap.

Conditions

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Cervical Dystonia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Complex-free BoNT/A formulation

Patients exclusively treated with the complex-free (CF) formulation (incobotulinumtoxinA). A maximum of 328 patients will be enrolled in this group.

CF BoNT/A

Intervention Type BIOLOGICAL

Complex-free BotulinumtoxinA (BoNT/A) formulation

Complex-containing BoNT/A formulations

Patients exclusively treated with a single complex-containing (CC) formulation (onabotulinumtoxinA or abobotulinumtoxinA). A maximum of 328 patients will be enrolled in this group.

CC BoNT/A

Intervention Type BIOLOGICAL

Complex-containing BotulinumtoxinA (BoNT/A) formulations

Switcher CF to CC BoNT/A formulations

The CF to CC switcher group includes all patients that were switched from a CF to a CC BoNT/A formulation. If more than one switch occurred, the first switch determines the group. Both switcher groups will in sum not exceed 325 patients.

CF to CC BoNT/A

Intervention Type BIOLOGICAL

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

Switcher CC to CF BoNT/A formulations

The CC to CF switcher group includes all patients that were switched from a CC to a CF BoNT/A formulation. If more than one switch occurred, the first switch determines the group. Both switcher groups will in sum not exceed 325 patients.

CC to CF BoNT/A

Intervention Type BIOLOGICAL

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

Interventions

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CC BoNT/A

Complex-containing BotulinumtoxinA (BoNT/A) formulations

Intervention Type BIOLOGICAL

CF BoNT/A

Complex-free BotulinumtoxinA (BoNT/A) formulation

Intervention Type BIOLOGICAL

CF to CC BoNT/A

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

Intervention Type BIOLOGICAL

CC to CF BoNT/A

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

Intervention Type BIOLOGICAL

Other Intervention Names

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onabotulinumtoxinA abobotulinumtoxinA incobotulinumtoxinA NT 201 Botulinum toxin type A (150 kiloDalton), free from complexing proteins incobotulinumtoxinA onabotulinumtoxinA abobotulinumtoxinA onabotulinumtoxinA abobotulinumtoxinA incobotulinumtoxinA

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No