Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT06886750
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06886750
Study Brief:
Protocol Section:
NCT06886750