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

NCT04871451 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ABP-19002
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 20

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.

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-related Serious Adverse Events

  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.

  Up to 52 weeks

Secondary Outcomes (6)

• Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score

  Four weeks after the dose of each cycle (4 cycles)

• 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)

• 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)

• 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)

• Mean Change in Patient Global Impression of Change (PGI-C)

  Four weeks after the dose of each cycle (4 cycles)

Study Arms (1)

ABP-450 - Between Low Dose and High Dose

EXPERIMENTAL

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.

Drug: ABP-450

Interventions

ABP-450 DRUG

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

Also known as: prabotulinumtoxinA

ABP-450 - Between Low Dose and High Dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AEON Biopharma, Inc.: lead

Study Sites (20)

Arizona Neuroscience Research

Phoenix, Arizona, 85032, United States

Location

Parkinson's and Movement Disorder Institute

Fountain Valley, California, 92708, United States

Location

Neuro Pain Medical Center

Fresno, California, 93710, United States

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

New England Institute for Neurology and Headache

Stamford, Connecticut, 06905, United States

Location

Infinity Clinical Research LLC

Hollywood, Florida, 33024, United States

Location

Brainstorm Research

Miami, Florida, 33176, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Neurology One

Winter Park, Florida, 32792, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Quest Research Institute - Hunt - PPDS

Farmington Hills, Michigan, 48334, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Cleveland Clinic Lou Ruvo Center for Brain Health

Cleveland, Ohio, 89106, United States

Location

The Orthopedic Foundation

New Albany, Ohio, 43054, United States

Location

Veracity Neuroscience LLC

Memphis, Tennessee, 38157, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Torticollis

Interventions

prabotulinumtoxin A

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dana Testa, PharmD
• Organization: AEON Biopharma, Inc.

dt@aeonbiopharma.com

949-354-6499

Study Officials

• Cynthia Comella

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Joseph Jankovic

  Baylor St. Luke's Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: July 27, 2021
• Primary Completion: July 24, 2023
• Study Completion: July 24, 2023
• Last Updated: August 22, 2024
• Results First Posted: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)