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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported