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

NCT ID: NCT04871451

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-27
• Study Completion Date: 2023-07-24

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.

Conditions

Cervical Dystonia

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABP-450 - Between Low Dose and High Dose

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.

Group Type: EXPERIMENTAL

ABP-450

Intervention Type: DRUG

ABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.

Interventions

ABP-450

ABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.

Intervention Type: DRUG

Other Intervention Names

prabotulinumtoxinA

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AEON Biopharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia Comella

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Joseph Jankovic

Role: PRINCIPAL_INVESTIGATOR

Baylor St. Luke's Medical Center

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABP-19002

Identifier Type: -

Identifier Source: org_study_id