A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia
Purpose
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.
Condition
- Cervical Dystonia
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Approximately 60 patients will be randomized in a 1:1:1:1 ratio and receive one of the four treatments: ABP-450 low dose, ABP-450 mid dose, ABP-450 high dose, or placebo via intramuscular injection into affected neck muscles.
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- The investigator, study nurse/other study personnel, and patients will be blinded to the treatment group. An appropriately trained person will reconstitute investigational product, fill masked syringes and provide them to the blinded investigator, but will not perform any assessments with the patient.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ABP-450 - Low Dose |
ABP-450 Low Dose - Intramuscular injections into affected neck muscles. |
|
|
Experimental ABP-450 - Medium Dose |
ABP-450 Mid Dose - Intramuscular injections into affected neck muscles. |
|
|
Experimental ABP-450 - High Dose |
ABP-450 High Dose - Intramuscular injections into affected neck muscles. |
|
|
Placebo Comparator Placebo |
Placebo (0.9% saline, sterile, unpreserved, USP/Ph.Eur.) - Intramuscular injections into affected neck muscles. |
|
More Details
- Status
- Completed
- Sponsor
- AEON Biopharma, Inc.
Study Contact
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.