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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 April 23, 2025

Not yet recruiting

Keywords

Botulinum Toxin Injections Waning Effect Dystonia

ClinConnect Summary

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 toxin type A (BoNT-A) is an effective and safe first-line therapy for CD. However, in a recent patient perspective survey, symptom re-emergence between injections (a mean 10.5 weeks) was reported in 88% of patients with a waning time of ≤8 weeks in one-third of patients. Waning treatment effects prior to re-injection reduces quality of life as 47% of patients are somewhat satisfied, and 39% were not...

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

Trial Officials

Mandar Jog, MD

Principal Investigator

Univ of Western Ontario

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported