Category: Dystonia: Clinical Trials and Therapy
Objective: To evaluate the safety and the efficacy of ABP-450 (prabotulinumtoxinA) in patients with cervical dystonia (CD).
Background: ABP-450 (prabotulinumtoxinA) is a new 900kDA botulinumtoxinA.
Method: Adult subjects with moderate to severe CD with a baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score of ≥20 were invited to participate in a randomized double blinded, multi-center, placebo-controlled study of ABP-450 at doses of 150 U, 250 U and 350 U. The study drug was administered to the affected muscles and the subjects were evaluated every 4 weeks following the injection. At least 6 weeks post injection, the subjects were invited to discontinue their participation in the blinded study and enroll in the open label extension if there was minimal response or loss of efficacy in the opinion of the investigators and the subjects. The primary efficacy outcome was the change in TWSTRS from baseline to week 4. The secondary outcomes included the duration of effect, patient global impression of change (PGI-C) and clinical global impression of change (CGI-C) at week 4.
Results: Of the 70 subjects screened, 61 were randomized, 59 were dosed, and 57 were included in the efficacy analysis. Treatment effect (vs. placebo) based on mean change from baseline in TWSTRS total score at week 4 was -10.44 (p=0.0070) for 150U, -7.71 (p=0.0406) for 250U, and -6.35 (p=0.0864) for 350U. There was no statistically significant difference between the three doses. CGI-C and PGI-C were statistically significantly improved over placebo at week 4 in all three ABP-450 groups and the median duration of treatment effect were ≥20. Treatment-related adverse events, reported in 16 subjects (36%), included dysphagia (11.1%), neck weakness (6.7%), and headache (4.4%).
Conclusion: ABP-450 at doses of 150U and 250U demonstrated statistically significant and clinically meaningful efficacy with relatively sustained benefit. ABP-450 appeared to be generally safe and well tolerated.
To cite this abstract in AMA style:
J. Jankovic, C. Oh, Y. Liu, C. Comella. A Phase 2, Double-blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ABP-450 (PrabotulinumtoxinA) in Adults with Isolated Cervical Dystonia [abstract]. Mov Disord. 2023; 38 (suppl 1). https://www.mdsabstracts.org/abstract/a-phase-2-double-blinded-placebo-controlled-trial-to-evaluate-the-efficacy-and-safety-of-abp-450-prabotulinumtoxina-in-adults-with-isolated-cervical-dystonia/. Accessed June 23, 2025.« Back to 2023 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/a-phase-2-double-blinded-placebo-controlled-trial-to-evaluate-the-efficacy-and-safety-of-abp-450-prabotulinumtoxina-in-adults-with-isolated-cervical-dystonia/