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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT04871451
Eligibility Criteria:
Inclusion Criteria:
1. Qualified for and had their initial dose of study drug in the ABP-19000 study.
2. Provided written informed consent to being treated for cervical dystonia with ABP-450.
3. Were a male or female patient between 18 and 75 years of age (inclusive) when they entered the ABP-19000 study.
4. Stated willingness to comply with all study procedures, including attendance at the study center for all study visits as scheduled and have technological capabilities to have tele visits.
Exclusion Criteria:
1. Participated in another interventional study during participation in this study.
2. Were a pregnant or lactating female, or female of child-bearing potential not willing to use an acceptable method of contraception (ie, intrauterine device, barrier methods with spermicide, or abstinence).
3. Would not benefit from treatment with ABP-450 for their cervical dystonia, in the investigator's opinion.
4. Viral or other active infection or any medical condition that, in the opinion of the investigator, classifies the patient as unsuitable for participation in the study or patients who do not seem to be in good general health at the time of Day 0 "rollover", and prior to any investigational study drug administration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04871451
Study Brief:
Protocol Section:
NCT04871451