Status:
NOT_YET_RECRUITING
The Effects of Waning of Botulinum Toxin in the Treatment of Cervical Dystonia
Lead Sponsor:
Western University, Canada
Collaborating Sponsors:
Manjog Enterprises Limited
Conditions:
Cervical Dystonia, Primary
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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, botuli...
Detailed Description
Cervical dystonia (CD) is a disabling and often painful condition clinically characterized by abnormal neck and head postures and movements often associated with tremor and chronic pain. Botulinum tox...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06886750
Start Date
March 30 2025
End Date
December 30 2027
Last Update
March 20 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.