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Search / Trial NCT06886750

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

Launched by WESTERN UNIVERSITY, CANADA · Mar 13, 2025

Trial Information

Current as of May 09, 2025

Not yet recruiting

Keywords

Botulinum Toxin Injections Waning Effect Dystonia

ClinConnect Summary

This clinical trial is studying a new approach to help people with cervical dystonia, a condition that causes involuntary neck muscle contractions. The main treatment for this condition is botulinum toxin injections, which can lose their effectiveness over time. In this study, researchers want to see if switching from the usual botulinum toxin brands (like Botox or Xeomin) to a different one called Dysport can help patients experience longer relief from their symptoms. Patients who feel their current treatment isn’t lasting long enough may be eligible to participate.

To qualify for the study, participants must be 18 years or older, have been diagnosed with isolated cervical dystonia, and have experienced some relief from their current treatment but find it wears off within eight weeks. The trial will involve giving treatments every three months for a total of three injections, with some patients receiving Dysport and others continuing with their original treatment, all while keeping the details of their treatment a secret from them to ensure unbiased results. Participants will visit local clinics for their treatments and monitoring, and the study is not yet recruiting patients.

Gender

ALL

Eligibility criteria

  • 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

About Western University, Canada

Western University, located in Canada, is a leading research institution committed to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses the expertise of its faculty and research teams to conduct high-quality studies that address pressing medical challenges. Western University is dedicated to fostering a culture of ethical research practices, ensuring participant safety, and generating impactful findings that contribute to evidence-based medicine and improve patient outcomes. Through its robust infrastructure and commitment to excellence, Western University plays a vital role in the field of clinical research.

Locations

Patients applied

0 patients applied

Trial Officials

Mandar Jog, MD

Principal Investigator

Univ of Western Ontario

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported