A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia

NCT ID: NCT04849988

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2022-07-11

Brief Summary

This Phase 2 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 30 sites in the United States. Study subjects will be divided evenly across a low dose group, a medium dose group, a high dose group, and a placebo group for one treatment cycle.

Detailed Description

This Phase 2 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 30 sites in the United States. Study subjects will be divided evenly across a low dose, a medium dose group, a high dose and placebo group for one treatment cycle.

Conditions

Cervical Dystonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ABP-450 - Low Dose

ABP-450 Low Dose - Intramuscular injections into affected neck muscles.

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.

ABP-450 - Medium Dose

ABP-450 Mid Dose - Intramuscular injections into affected neck muscles.

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.

ABP-450 - High Dose

ABP-450 High Dose - Intramuscular injections into affected neck muscles.

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.

Placebo

Placebo (0.9% saline, sterile, unpreserved, USP/Ph.Eur.) - Intramuscular injections into affected neck muscles.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% sodium chloride, sterile, unpreserved, USP/Ph.Eur.

Interventions

ABP-450

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

Intervention Type: DRUG

Placebo

0.9% sodium chloride, sterile, unpreserved, USP/Ph.Eur.

Intervention Type: DRUG

Other Intervention Names

prabotulinumtoxinA; 0.9% sodium chloride; saline

Eligibility Criteria

Inclusion Criteria

1. Male or female patients between 18 and 75 years of age (inclusive)

2. A clinical diagnosis of cervical dystonia (ie, spasmodic torticollis) defined by:

• TWSTRS total score ≥20
• TWSTRS severity score ≥10
• TWSTRS disability score ≥3
• TWSTRS pain score ≥1

3. On a stable dose of medications (if any) used for focal dystonia treatment (eg, anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the study duration

4. For pre-treated patients only: Source documentation (eg, patient history) of the last 2 consecutive injection sessions with a botulinum toxin type A

5. For pre-treated patients only: At least 16 weeks must have passed between the last injection with botulinum toxin for cervical dystonia and baseline treatment (patients can be screened at Week 15 but cannot be enrolled until 16 weeks [for Day 0 injection])

6. Provided written informed consent to being treated for cervical dystonia with ABP-450

7. 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 televisits

Exclusion Criteria

1. Traumatic torticollis or tardive torticollis

2. Predominant retrocollis or anterocollis

3. Myotomy or denervation surgery in the affected muscles (eg, peripheral denervation and/or spinal cord stimulation)

4. Hypersensitivity to human serum albumin, sucrose, or botulinum toxin type A

5. Previous treatment for cervical dystonia with rimabotulinumtoxin B

6. Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease that might interfere with the trial

7. Current swallowing disorder of any origin (dysphagia scale ≥3, ie, severe, with swallowing difficulties and requiring a change in diet)

8. Marked limitation on passive range of motion that suggests contractures or other structural abnormality, eg, cervical contractures or cervical spine syndrome

9. Treatment with botulinum toxins of any type for any indication other than cervical dystonia within 16 weeks prior to baseline and during the study

10. Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study

11. Participation in another interventional study during participation in this study

12. Pregnant or lactating females, or females of child-bearing potential not willing to use an acceptable method of contraception (ie, intrauterine device, barrier methods with spermicide, or abstinence)

13. For pre-treated patients only: The patient's most recent injection with botulinum toxin exceeding the number of units specified as follows:

• OnabotulinumtoxinA (BOTOX®): >300 units
• IncobotulinumtoxinA (Xeomin®): >300 units
• AbobotulinumtoxinA (Dysport®): >750 units

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

Sponsors

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

AEON Biopharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia Comella, MD

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

Movement Disorder Center of Arizona

Scottsdale, 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

The Neurology Research Group

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-19000

Identifier Type: -

Identifier Source: org_study_id