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 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT03905304
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged between 20 and 75.
* Patient who is diagnosed with primary cervical dystonia over 1 year.
* Patients whose total score is over 20 in TWSTRS and the severity score is over 10 in TWSTRS.
* For patients with prior treatments of Botox®, over 12 weeks have passed.
* Patients who voluntarily sign the informed consent
* Patients who can comply with the study procedures and visit schedule
Exclusion Criteria:
* Patient who has been diagnosed with pure anterocollis.
* Patient who has been diagnosed with neuromuscular disorder(myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)\\
* Severe respiratory function disorder or dysphasia
* Allergy in Investigational Product.
* Pregnant women, breast feeding women and patients disagreeing to use an acceptable contraception method
* Investigator's decision.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT03905304
Study Brief:
Protocol Section:
NCT03905304