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Assessment of Long-term Clinical Response to BoNT in Cervical Dystonia (RELY-CD)

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ClinicalTrials.gov Identifier: NCT05884528
Recruitment Status : Recruiting
First Posted : June 1, 2023
Last Update Posted : April 19, 2024
Sponsor:
Collaborator:
Heinrich-Heine University, Duesseldorf
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH ( Merz Therapeutics GmbH )

Study Description
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Brief 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).


Condition or disease Intervention/treatment
Cervical Dystonia Biological: CC BoNT/A Biological: CF BoNT/A Biological: CF to CC BoNT/A Biological: CC to CF BoNT/A

Detailed Description:

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 981 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Assessment of Long-term Clinical Response to BoNT in Cervical Dystonia - Real-world Evidence of LongevitY of Botulinum Toxin in Cervical Dystonia
Actual Study Start Date : July 8, 2023
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Biological: CF BoNT/A
Complex-free BotulinumtoxinA (BoNT/A) formulation
Other Names:
  • incobotulinumtoxinA
  • NT 201
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins
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.
 Biological: CC BoNT/A
Complex-containing BotulinumtoxinA (BoNT/A) formulations
Other Names:
  • onabotulinumtoxinA
  • abobotulinumtoxinA
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.
 Biological: CF to CC BoNT/A
Switch from complex-free to complex-containing BoNT/A formulations
Other Names:
  • incobotulinumtoxinA
  • onabotulinumtoxinA
  • abobotulinumtoxinA
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.
 Biological: CC to CF BoNT/A
Switch from complex-containing to complex-free BoNT/A formulations
Other Names:
  • onabotulinumtoxinA
  • abobotulinumtoxinA
  • incobotulinumtoxinA


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will comprise of patients with a diagnosis of cervical dystonia who received regular BoNT/A injections for symptomatic treatment of the disease. The sub-populations consist of long-term patients treated with only ever one BoNT/A formulation (monotherapy) or 2 BoNT/A formulations (switcher).
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05884528


Contacts
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Contact: Benjamin Waeschle +496915030 benjamin.waeschle@uni-duesseldorf.de
Contact: Public Disclosure Manager +496915030 clinicaltrials@merz.de

Locations
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Germany
Düsseldorf University Hospital Recruiting
Düsseldorf, North Rhine-Westphalia, Germany, 40255
Contact: Philipp Albrecht, M.D.         
Sponsors and Collaborators
Merz Therapeutics GmbH
Heinrich-Heine University, Duesseldorf
Investigators
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Study Director: Merz Medical Expert Merz Therapeutics
More Information
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Publications:

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Responsible Party: Merz Therapeutics GmbH
ClinicalTrials.gov Identifier: NCT05884528    
Other Study ID Numbers: M602011073
First Posted: June 1, 2023    Key Record Dates
Last Update Posted: April 19, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merz Pharmaceuticals GmbH ( Merz Therapeutics GmbH ):
spasmodic torticollis, focal dystonia
Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
 abobotulinumtoxinA
incobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents