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 : May 20, 2024
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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).
Condition or disease | Intervention/treatment |
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Cervical Dystonia | Biological: CC BoNT/A Biological: CF BoNT/A Biological: CF to CC BoNT/A Biological: CC to CF BoNT/A |
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 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 |
Group/Cohort | Intervention/treatment |
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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.
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Biological: CF BoNT/A
Complex-free BotulinumtoxinA (BoNT/A) formulation
Other Names:
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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.
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Biological: CC BoNT/A
Complex-containing BotulinumtoxinA (BoNT/A) formulations
Other Names:
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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.
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Biological: CF to CC BoNT/A
Switch from complex-free to complex-containing BoNT/A formulations
Other Names:
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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.
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Biological: CC to CF BoNT/A
Switch from complex-containing to complex-free BoNT/A formulations
Other Names:
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- 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.
- 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 ]
- Incidence of frequent AEs overall and in patients with altered dose-effect [ Time Frame: Years 2, 5,7, and 10 ]
- Health-related quality of life measured by the EQ-5D [ Time Frame: Years 2, 5,7, and 10 ]
- Health-related quality of life measured by the SF-36 [ Time Frame: Years 2, 5,7, and 10 ]
- Health-related quality of life measured by the CDQ24 [ Time Frame: Years 2, 5,7, and 10 ]
- 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 ]
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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 |
- 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.
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
Contact: Benjamin Waeschle | +496915030 | benjamin.waeschle@uni-duesseldorf.de | |
Contact: Public Disclosure Manager | +496915030 | clinicaltrials@merz.de |
Germany | |
Düsseldorf University Hospital | Recruiting |
Düsseldorf, North Rhine-Westphalia, Germany, 40255 | |
Contact: Philipp Albrecht, M.D. |
Study Director: | Merz Medical Expert | Merz Therapeutics |
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: | May 20, 2024 |
Last Verified: | May 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
spasmodic torticollis, focal dystonia |
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 |