A total of 118 participants were enrolled at 22 sites, and 117 received at least one dose of SMART AboBoNT-A. The full analysis set included 108 participants with available baseline documentation and post-baseline primary endpoint data. The primary endpoint, change in DAS PTT score from baseline to Week 12–16 (Visit 3), showed clinically and statistically significant improvement. Mean DAS decreased from 2.7 at baseline to 1.9 at Visit 3, corresponding to a mean change of –0.8. Nearly 60% of participants were considered responders, i.e. achieving the minimum detectable, clinically meaningful improvement of at least one level, and no subject worsened.
Secondary endpoints supported these results. MAS PTMG decreased by an average of –0.75, and nearly two-thirds of subjects met the responder definition, i.e., achieving the minimum clinically meaningful improvement of at least one grade. Pain VAS improved by –2.05 points, which constitutes, according to the literature, a meaningful reduction in the context of chronic neurological pain. The SQoL-6D total score improved by an average of 16 points, with consistent improvements across all functional domains. Twelve participants experienced 19 treatment-emergent adverse events (TEAEs), none of which were considered related to the study treatment. Nine participants experienced serious TEAEs, and five deaths occurred. All deaths were assessed as unrelated to AboBoNT-A and consistent with the advanced age and comorbidity burden typical of a chronic post-stroke population. No AEs of special interest, such as hypersensitivity reactions or potential remote spread of toxin, were reported, and no participants discontinued treatment due to adverse events.
Conclusion: These results indicate that SMART-guided BoNT-A treatment provides benefit across functional, symptomatic, and quality-of-life dimensions relevant to patients with post-stroke spasticity. Overall, SMART-guided AboBoNT-A therapy was well tolerated with no safety concerns