Clinical trial NCT04871451: Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia
Official title: An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Repeat Intramuscular ABP-450 (prabotulinumtoxinA) Injection for the Treatment of Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Dystonia
Lead sponsor: AEON Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Approximately 60 subjects from ABP-19000 study, irrespective of treatment allocation, will have the option to continue treatment with ABP-450 via intramuscular injection into affected neck muscles.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Treatment-related Serious Adverse Events
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
timeFrame: Four weeks after the dose of each cycle (4 cycles)
measure: Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
timeFrame: Four weeks after the dose of each cycle (4 cycles)
measure: Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS)
timeFrame: Four weeks after the dose of each cycle (4 cycles)
measure: Mean Change in the Subscale Score of Pain of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
timeFrame: Four weeks after the dose of each cycle (4 cycles)
measure: Mean Change in Patient Global Impression of Change (PGI-C)
timeFrame: Four weeks after the dose of each cycle (4 cycles)
measure: Mean Change in Clinical Global Impression of Change (CGI-C)
timeFrame: Four weeks after the dose of each cycle (4 cycles)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Neuroscience Research
state: Arizona
city: Fountain Valley
country: United States
facility: Parkinson's and Movement Disorder Institute
state: California
city: Fresno
country: United States
facility: Neuro Pain Medical Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Stamford
country: United States
facility: New England Institute for Neurology and Headache
state: Connecticut
city: Hollywood
country: United States
facility: Infinity Clinical Research LLC
state: Florida
city: Miami
country: United States
facility: Brainstorm Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Winter Park
country: United States
facility: Neurology One
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Farmington Hills
country: United States
facility: Quest Research Institute - Hunt - PPDS
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health
state: Ohio
city: New Albany
country: United States
facility: The Orthopedic Foundation
state: Ohio
city: Memphis
country: United States
facility: Veracity Neuroscience LLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Rush University Medical Center
name: Cynthia Comella
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor St. Luke's Medical Center
name: Joseph Jankovic
role: PRINCIPAL_INVESTIGATOR
References: