Long-Term Safety and Efficacy of Repeat Treatments with DaxibotulinumtoxinA in Cervical Dystonia: Results from the ASPEN-Open-Label Study.

ABSTRACT:

Background

DaxibotulinumtoxinA (DAXI), a novel botulinum neurotoxin (BoNT) formulation, was shown to be safe, effective, and long-lasting in the treatment of cervical dystonia (CD) over one treatment cycle in the phase 3, randomized, placebo-controlled ASPEN-1 trial.

Objectives

To evaluate the safety, immunogenicity, and efficacy of repeat DAXI treatments for CD over 52 weeks in the phase 3, open-label ASPEN-OLS (NCT03617367).

Methods

Adults with moderate-to-severe CD (Toronto Western Spasmodic Torticollis Rating Scale [TWSTRS] score ≥20) initially received DAXI 125U or 250U based on treatment history and investigator judgment. Retreatment could be titrated (50U-75U) each cycle (maximum 300U) for up to four cycles over 52 weeks. Assessments were conducted at Week 4, 6

SUBMITTER: McAllister P 

PROVIDER: S-EPMC12625142 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature