A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia (NCT04849988) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia
United States61 participantsStarted 2021-03-29
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female patients between 18 and 75 years of age (inclusive)
✓. A clinical diagnosis of cervical dystonia (ie, spasmodic torticollis) defined by:
✓. 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 criteria
✕. 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)
✕
What they're measuring
1
Number of Participants With Treatment-Related Serious Adverse Events
. 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