The Effects of Waning of Botulinum Toxin in the Treatment of Cervical Dystonia (NCT06886750) | Clinical Trial Compass
Not Yet RecruitingPhase 4
The Effects of Waning of Botulinum Toxin in the Treatment of Cervical Dystonia
45 participantsStarted 2025-03-30
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Waining time.
Timeframe: At the end of each cycle for 3 cycles. Each cycle is 12 weeks in duration as the reinjection is done every 12 weeks.