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Cervical DystoniaRELY-CDNCT05884528

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

An observational study of Cervical Dystonia, run by Merz Therapeutics GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Cervical Dystonia
What is being tested?
CC BoNT/A, CF BoNT/A and CF to CC BoNT/A
How many people
270 participants
Where
1 siteGermany
Study dates
8 Jul 2023to 31 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

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).

  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Düsseldorf University Hospital

    Düsseldorf, North Rhine-Westphalia, 40255

Other trials in Germany

About this study

Official title: Assessment of Long-term Clinical Response to BoNT in Cervical Dystonia - Real-world Evidence of LongevitY of Botulinum Toxin 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).

Read the 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.

Being tested
CC BoNT/A, CF BoNT/A, CF to CC BoNT/A, CC to CF BoNT/A
Keywords
spasmodic torticollis, focal dystonia
Medical subject headings
Torticollis, Dystonic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC BoNT/ABiological

    Also called onabotulinumtoxinA, abobotulinumtoxinA

    Complex-containing BotulinumtoxinA (BoNT/A) formulations

  • CF BoNT/ABiological

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

    Complex-free BotulinumtoxinA (BoNT/A) formulation

  • CF to CC BoNT/ABiological

    Also called incobotulinumtoxinA, onabotulinumtoxinA, abobotulinumtoxinA

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

  • CC to CF BoNT/ABiological

    Also called onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA

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

Study groups in NCT05884528
Study groupRoleWhat they receive
Complex-free BoNT/A formulationPatients exclusively treated with the complex-free (CF) formulation (incobotulinumtoxinA). A maximum of 328 patients will be enrolled in this group.
Receives: Biological: CF BoNT/A
Complex-containing BoNT/A formulationsPatients exclusively treated with a single complex-containing (CC) formulation (onabotulinumtoxinA or abobotulinumtoxinA). A maximum of 328 patients will be enrolled in this group.
Receives: Biological: CC BoNT/A
Switcher CF to CC BoNT/A formulationsThe 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.
Receives: Biological: CF to CC BoNT/A
Switcher CC to CF BoNT/A formulationsThe 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.
Receives: Biological: CC to CF BoNT/A

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

    Measured: Year 2 and year 7

Secondary outcomes (1)

  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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2023
  2. Study start8 Jul 2023
  3. Primary completion31 May 2024
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05884528
Sponsor's protocol ID
M602011073
Acronym
RELY-CD
Status last verified
Aug 2024
First submitted
8 May 2023
Last updated
21 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ware JE Jr, Kosinski M, Gandek B, Aaronson NK, Apolone G, Bech P, Brazier J, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. The factor structure of the SF-36 Health Survey in 10 countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1159-65. doi: 10.1016/s0895-4356(98)00107-3.

    PubMed 9817133

  • Albanese A, Bhatia K, Bressman SB, Delong MR, Fahn S, Fung VS, Hallett M, Jankovic J, Jinnah HA, Klein C, Lang AE, Mink JW, Teller JK. Phenomenology and classification of dystonia: a consensus update. Mov Disord. 2013 Jun 15;28(7):863-73. doi: 10.1002/mds.25475. Epub 2013 May 6.

    PubMed 23649720

  • Albrecht P, Jansen A, Lee JI, Moll M, Ringelstein M, Rosenthal D, Bigalke H, Aktas O, Hartung HP, Hefter H. High prevalence of neutralizing antibodies after long-term botulinum neurotoxin therapy. Neurology. 2019 Jan 1;92(1):e48-e54. doi: 10.1212/WNL.0000000000006688. Epub 2018 Nov 21.

    PubMed 30464031

  • Carr WW, Jain N, Sublett JW. Immunogenicity of Botulinum Toxin Formulations: Potential Therapeutic Implications. Adv Ther. 2021 Oct;38(10):5046-5064. doi: 10.1007/s12325-021-01882-9. Epub 2021 Sep 13.

    PubMed 34515975

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Dystonia, run by Merz Therapeutics GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05884528, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.

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