Status:
COMPLETED
A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia
Lead Sponsor:
AEON Biopharma, Inc.
Collaborating Sponsors:
PPD Development, LP
Conditions:
Cervical Dystonia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 Stat...
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 Stat...
Eligibility Criteria
Inclusion
- Male or female patients between 18 and 75 years of age (inclusive)
- 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
- 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
- For pre-treated patients only: Source documentation (eg, patient history) of the last 2 consecutive injection sessions with a botulinum toxin type A
- 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 \[for Day 0 injection\])
- Provided written informed consent to being treated for cervical dystonia with ABP-450
- 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
- Traumatic torticollis or tardive torticollis
- Predominant retrocollis or anterocollis
- Myotomy or denervation surgery in the affected muscles (eg, peripheral denervation and/or spinal cord stimulation)
- Hypersensitivity to human serum albumin, sucrose, or botulinum toxin type A
- Previous treatment for cervical dystonia with rimabotulinumtoxin B
- Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease that might interfere with the trial
- Current swallowing disorder of any origin (dysphagia scale ≥3, ie, severe, with swallowing difficulties and requiring a change in diet)
- Marked limitation on passive range of motion that suggests contractures or other structural abnormality, eg, cervical contractures or cervical spine syndrome
- Treatment with botulinum toxins of any type for any indication other than cervical dystonia within 16 weeks prior to baseline and during the study
- 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
- Participation in another interventional study during participation in this study
- 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)
- 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
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2022
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04849988
Start Date
March 29 2021
End Date
July 11 2022
Last Update
February 14 2024
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Neuroscience Research
Phoenix, Arizona, United States, 85032
2
Movement Disorder Center of Arizona
Scottsdale, Arizona, United States, 85258
3
Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
4
Neuro Pain Medical Center
Fresno, California, United States, 93710