The Effects of Waning of Botulinum Toxin in the Treatment of Cervical Dystonia

NCT06886750 | Not Yet Recruiting Phase 4

• 1 other identifier: Dysportstudy1
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main treatment for cervical dystonia is botulinum toxin injections. However, some patients receiving this treatment after many years tend to experience short duration of benefit. Typically, botulinum toxin brands used in clinic are Botox or Xeomin. Another type of botulinum toxin is called Dysport (Ipsen Biopharmaceuticals), and Dysport may increase duration of benefit from the injections. The study is selecting patients from the investigator's clinics who are not satisfied with the duration of their treatment and are willing to switch to Dysport and the investigators will monitor if Dysport will increase the duration of benefit over a total of 3 treatments. A group of patients will be switched to Dysport while another group will remain on their original botulinum toxin formulation. The patients will be unaware of the treatment switch and hence are considered to be blinded. The investigators will not be blinded. Treatments are given every 3 months. All study visits will occur at the local sites of the 3 recruiting sites.

Conditions

Cervical Dystonia, Primary

Keywords

botulinum toxin injections; waning effect; dystonia

Outcome Measures

Primary Outcomes (1)

• Waining time.

  Waning time - time from last injection to participant perception of treatment effects starting to wear off. An increase in waning time is a better outcome. Values will be between 8 to 12 weeks.

  At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.

Secondary Outcomes (4)

• • Modified Tsui Scale

  At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.

• • 5-point Likert participant reported treatment satisfaction tool

  At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.

• • Onset of treatment relief using the symptom tracker

  At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.

• • Safety of the use of botulinum toxin injection for cervical dystonia

  At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.

Study Arms (2)

aboBoNT-A

ACTIVE COMPARATOR

1. Next 3 injections (every 12 weeks) are using aboBoNT-A (Dysport) 2. First Dysport injection: 1:2.5 ona/incoBoNT-A: aboBoNT-A dose ratio conversion (reconstitution is 2 ml in a 500 U aboBoNT-A vial) (V1) 3. Second and third injection: clinical optimization of aboBoNT-A dosing pattern at 12-weeks post aboBoNT-A injection. (V2 and V3). The 12 week period is compulsory. 4. Return to original BoNT-A formulation (1:2.5 ona/incoBoNT-A: aboBoNT-A dose ratio), using same injection pattern as V3 (V4) 5. Non-injection final study visit to conduct all assessments (V5)

Drug: Botulinum toxin type A injection

Original toxin arm

ACTIVE COMPARATOR

1. Next 3 injections (every 12 weeks) are the same toxin as the original 2. First injection: Dose may be optimized as per the investigators discretion or kept the same (reconstitution is 1 ml in a 100 U ona/incoBoNT-A vial) (V1) 3. Second and third injection: clinical optimization of the dose as required with dosing pattern at weeks 12 post injection. (V2 and V3). The 12 week period is compulsory. 4. Continue with the original toxin, using same injection pattern as V3 (V4) 5. Non-injection final study visit to conduct all assessments (V5)

Drug: Botulinum toxin type A injection

Interventions

Botulinum toxin type A injection DRUG

Injection of toxin

Original toxin arm; aboBoNT-A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or above with a diagnosis of isolated CD
• Experience efficacious relief with a waning time of ≤8 weeks post-injection
• Must have received the same dose and injection pattern of onaBoNT-A or incoBoNT-A for at least 3 injection cycles prior to study initiation with an injection cycle of 12 weeks

You may not qualify if:

• Require a total dose \<80 U or \>300 U ona/incoBoNT-A
• Pure reterocollis or suspected secondary non-responsiveness
• No interest in switching between BoNT-A formulations
• Prolonged history of dysphagia
• History of poor response to BoNT-A or BoNT-B
• Inability to complete study visits or sign informed consent
• Pregnancy
• Known resistance or contradictions to any BoNT-A
• Known hypersensitivity to BoNT-A or related compound

Sponsors & Collaborators

• Western University, Canada: lead
• Manjog Enterprises Limited: collaborator

Related Publications (1)

• Samotus O, Jog M. Conversion to AbobotulinumtoxinA Increases Waning Time and Efficacy for Cervical Dystonia. Mov Disord Clin Pract. 2023 Mar 1;10(5):756-763. doi: 10.1002/mdc3.13696. eCollection 2023 May.

  PMID: 37205243 BACKGROUND

MeSH Terms

Conditions

Cervical Dystonia, Primary; Dystonia

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Mandar Jog, MD

  Univ of Western Ontario

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mandar S Jog, MD

CONTACT

5196633814; mandar.jog@lhsc.on.ca

Rachna Jog, MBA

CONTACT

rach.jog@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patinet blinded to the toxin type
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blind study

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 20, 2025
• Study Start: March 30, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share