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:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT07233993
Eligibility Criteria:
Inclusion Criteria:
* Minimum age 18 years old
* Clinical diagnosis of Idiopathic Cervical Dystonia
* On a stable dose of other medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to screening and expected to be maintained throughout the study
* Treatment non-naïve to BoNT type A therapy for CD
* At least 4 months have passed between the last BoNT injection at screening
* Good clinical response to previous BoNT injections, on stable dosing and treatment scheme
* Informed Consent as documented by signature.
* Ability to perform study requirements (to attend assessment and treatments)
Exclusion Criteria:
* Diagnosis of other types of Cervical Dystonia (Inherited and Acquired)
* Concomitant diagnosis of diseases that contraindicate the use of botulinum toxin, such as myasthenia gravis
* Known hypersensitivity or allergy to Botulinum-A Toxin
* Women who are pregnant or breast feeding
* Intention to become pregnant during the study
* Lack of safe contraception
* Other clinically significant and unstable concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.).
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Previous enrolment into the current study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07233993
Study Brief:
Protocol Section:
NCT07233993