A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: ABP-450; Placebo
Intervention description: ABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.; 0.9% sodium chloride, sterile, unpreserved, USP/Ph.Eur.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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.
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.
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

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