Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia
- Conditions
- Cervical Dystonia
- Interventions
- Drug: ABP-450
- Registration Number
- NCT04871451
- Lead Sponsor
- AEON Biopharma, Inc.
- 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 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.
- 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 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. Study subjects will receive a predetermined dose of ABP-450 between the Low Dose and High Dose, based on the investigator's discretion and clinical judgment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ABP-450 - Between Low Dose and High Dose ABP-450 ABP-450 Between Low Dose and High Dose - Intramuscular injections into affected neck muscles with investigator's determined dose within the range of low dose and high dose - 4 injection cycles at 3-month intervals.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-related Serious Adverse Events Up to 52 weeks The primary safety endpoint will be the incidence of treatment-related serious adverse events since the start of treatment by Treatment Group when dosed with ABP-450 between Low Dose and High Dose.
- Secondary Outcome Measures
Name Time Method Mean Change in Patient Global Impression of Change (PGI-C) Four weeks after the dose of each cycle (4 cycles) The Patient Global Impression of Change (PGI-C) enables the patient to rate changes in their perception of their general health status over the duration of the assessment via a 7-point scale ranging from "much improved" to "much worse". The 7-point scale range is much improved (+3) to much worse (-3) with no change at "0". For the analysis, the data was transformed to a linear 7 point scale where 1 = much better and 7 = much worse.
The mean change in the subject's assessment of the change in clinical status since the start of treatment measured by the Patients' Global Impression of Change (PGI-C) Scale was assessed by Treatment Group at Week 4.Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS) Four weeks after the dose of each cycle (4 cycles) The Disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is used to assess the severity of disability in cervical dystonia. The disability subscale has a minimum score of 0 and maximum score of 30, where higher scores represent worse outcomes.
Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Four weeks after the dose of each cycle (4 cycles) The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale is used to assess the severity of cervical Dystonia. The TWSTRS-total score has a minimum score of 0 and a maximum score of 85, where higher scores represent worse outcomes. It comprises 3 subscales, which are summated to get the total score: the Torticollis Severity Scale (minimum score of 0, maximum score of 35), the Disability Scale (minimum score of 0, maximum score of 30), and the Pain Scale (minimum score of 0, maximum score of 20).
Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Four weeks after the dose of each cycle (4 cycles) The Pain subscale of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is used to assess the severity of pain in cervical dystonia. The pain subscale has a minimum score of 0 and maximum score of 20, where higher scores represent worse outcomes.
Mean Change in Clinical Global Impression of Change (CGI-C) Four weeks after the dose of each cycle (4 cycles) The Clinical Global Impression of Change (CGI-C) enables the patient to rate changes in their perception of their general health status over the duration of the assessment via a 7-point scale ranging from "much improved" to "much worse". The 7-point scale range is much improved (+3) to much worse (-3) with no change at "0". For the analysis, the data was transformed to a linear 7 point scale where 1 = much better and 7 = much worse.
The mean change from Baseline in the Clinical Global Impression of Change (CGI-C) Score was assessed by Treatment Group at Week 4.Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Four weeks after the dose of each cycle (4 cycles) The Severity subscale of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is used to assess the severity of torticollis in cervical dystonia. The severity subscale has a minimum score of 0 and maximum score of 35, where higher scores represent worse outcomes.
Trial Locations
- Locations (20)
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
New England Institute for Neurology and Headache
🇺🇸Stamford, Connecticut, United States
Neuro Pain Medical Center
🇺🇸Fresno, California, United States
Veracity Neuroscience LLC
🇺🇸Memphis, Tennessee, United States
The Orthopedic Foundation
🇺🇸New Albany, Ohio, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
🇺🇸Cleveland, Ohio, United States
Neurology One
🇺🇸Winter Park, Florida, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
Quest Research Institute - Hunt - PPDS
🇺🇸Farmington Hills, Michigan, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Brainstorm Research
🇺🇸Miami, Florida, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Arizona Neuroscience Research
🇺🇸Phoenix, Arizona, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Loma Linda University
🇺🇸Loma Linda, California, United States
Infinity Clinical Research LLC
🇺🇸Hollywood, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Parkinson's and Movement Disorder Institute
🇺🇸Fountain Valley, California, United States