Status:
COMPLETED
Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia
Lead Sponsor:
AEON Biopharma, Inc.
Conditions:
Cervical Dystonia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This Open-label Extension trial will evaluate the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 patients across approximately 42 sites in th...
Detailed Description
This Open-label Extension trial will evaluate the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 patients across approximately 42 sites in th...
Eligibility Criteria
Inclusion
- Qualified for and had their initial dose of study drug in the ABP-19000 study.
- Provided written informed consent to being treated for cervical dystonia with ABP-450.
- Were a male or female patient between 18 and 75 years of age (inclusive) when they entered the ABP-19000 study.
- 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
- Participated in another interventional study during participation in this study.
- 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).
- Would not benefit from treatment with ABP-450 for their cervical dystonia, in the investigator's opinion.
- 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.
Key Trial Info
Start Date :
July 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04871451
Start Date
July 27 2021
End Date
July 24 2023
Last Update
August 22 2024
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Neuroscience Research
Phoenix, Arizona, United States, 85032
2
Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
3
Neuro Pain Medical Center
Fresno, California, United States, 93710
4
Loma Linda University
Loma Linda, California, United States, 92354