Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia

Completed · Phase 2

Conditions studied: Cervical Dystonia

In brief

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 the United States from Phase 2 (ABP-19000) trial. Study subjects who had their initial dose of study drug in the Phase 2 trial, irrespective of treatment allocation, will be eligible to enroll in this OLE study.

Key facts

Study ID

NCT04871451

Run by

AEON Biopharma, Inc.

People needed

51

Starts

2021-07-27

Expected to finish

2023-07-24

Last updated by the study team

2024-08-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Neuroscience Research — Phoenix, Arizona, United States
• Parkinson's and Movement Disorder Institute — Fountain Valley, California, United States
• Neuro Pain Medical Center — Fresno, California, United States
• Loma Linda University — Loma Linda, California, United States
• New England Institute for Neurology and Headache — Stamford, Connecticut, United States
• Infinity Clinical Research LLC — Hollywood, Florida, United States
• Brainstorm Research — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Neurology One — Winter Park, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Michigan State University — East Lansing, Michigan, United States
• Quest Research Institute - Hunt - PPDS — Farmington Hills, Michigan, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Cleveland Clinic Lou Ruvo Center for Brain Health — Cleveland, Ohio, United States
• The Orthopedic Foundation — New Albany, Ohio, United States
• Veracity Neuroscience LLC — Memphis, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.