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NCT Number: NCT05884528

Assessment of Long-term Clinical Response to BoNT 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).

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Key information

Conditions

Cervical Dystonia Central Nervous System Diseases Dyskinesias Dystonia Dystonic Disorders Movement Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Düsseldorf University Hospital

Düsseldorf, North Rhine-Westphalia, 40255, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

CC BoNT/A

Biological

Complex-containing BotulinumtoxinA (BoNT/A) formulations

Other names: onabotulinumtoxinA, abobotulinumtoxinA

CF BoNT/A

Biological

Complex-free BotulinumtoxinA (BoNT/A) formulation

Other names: incobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kiloDalton), free from complexing proteins

CF to CC BoNT/A

Biological

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

Other names: incobotulinumtoxinA, onabotulinumtoxinA, abobotulinumtoxinA

CC to CF BoNT/A

Biological

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

Other names: onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA

Primary outcomes

  1. 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

    Time frame: Year 2 and year 7

    Dose-effect is a change in treatment response following dose adjustment.

Secondary outcomes

  1. 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

    Time frame: Baseline (first visit on record), years 2, 5, 7, and 10

Other outcomes

  1. Incidence of frequent AEs overall and in patients with altered dose-effect

    Time frame: Years 2, 5,7, and 10

  2. Health-related quality of life measured by the EQ-5D

    Time frame: Years 2, 5,7, and 10

  3. Health-related quality of life measured by the SF-36

    Time frame: Years 2, 5,7, and 10

  4. Health-related quality of life measured by the CDQ24

    Time frame: Years 2, 5,7, and 10

  5. Sub-analysis of all outcome measures in switcher population (patients treated with more than one BoNT/A formulation)

    Time frame: Years 2, 5,7, and 10

Sponsors and collaborators

Lead sponsor

Merz Therapeutics GmbH

Industry

Collaborators

  • Heinrich-Heine University, Duesseldorf

Registry information

Official study title

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

Acronym: RELY-CD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 1, 2023
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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