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A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2, Randomized, Double-Blind, Multicenter, Placebo Controlled Study to Evaluate the Safety and Efficacy of Intramuscular ABP-450 (prabotulinumtoxinA) Injection for the Treatment of Cervical Dystonia

NCT04849988•AEON Biopharma, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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
+6 more criteria

Locations (21)

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

Key Dates

Start Date

March 29, 2021

Primary Completion Date

July 11, 2022

Completion Date

July 11, 2022

Last Updated

February 14, 2024

Enrollment

ACTUAL participants

Conditions

Cervical Dystonia

Interventions

ABP-450

DRUG

Placebo

DRUG

Accelerating TMS for Cervical Dystonia

NCT06328114

Isolated Cervical Dystonia

View study

COMPLETEDNA

Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia

NCT03938363

Cervical Dystonia, PrimaryBlepharospasm

View study

COMPLETED

Cholinergic Receptor Imaging in Dystonia

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Accelerating TMS for Cervical Dystonia

Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia

Cholinergic Receptor Imaging in Dystonia

Propensity to Develop Plasticity in the Parieto-Motor Networks in Dystonia From the Perspective of Abnormal High-Order Motor Processing

Assessment of Long-term Clinical Response to BoNT in Cervical Dystonia

DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia