Trial reportMovement disorders clinical practice2025
Long-Term Safety and Efficacy of Repeat Treatments with DaxibotulinumtoxinA in Cervical Dystonia: Results from the ASPEN-Open-Label Study.
Trial report in Movement disorders clinical practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03617367 (A Phase 3, Open-Label, Multi-Center Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Open-Label, Multi-Center Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)
Who cites it
3 citing papers in PubMed.
- Trial
- DaxibotulinumtoxinA for Injection in Adults with Cervical Dystonia: Clinical Insights from a Real-World Early Experience Program.Movement disorders clinical practice · 2026Observational
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundDaxibotulinumtoxinA (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.
objectivesTo evaluate the safety, immunogenicity, and efficacy of repeat DAXI treatments for CD over 52 weeks in the phase 3, open-label ASPEN-OLS (NCT03617367).
methodsAdults 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, 12, and every 4 weeks until retreatment.
resultsIn all, 357 subjects received ≥1 dose of DAXI; most subjects (68.9%) received 250U during Cycle 1. Subjects most commonly received three (47.3%) or two (26.6%) treatments over 52 weeks. The average dose increased with successive cycles (Cycle 2: 239U, Cycle 3: 256U, Cycle 4: 270U). Mean (SD) change in TWSTRS score from baseline increased from -15.4 (10.3) in Cycle 1 to -19.9 (13.6) in Cycle 4. Median duration of effect was 20.1 weeks (Cycle 1, 2). No trend was observed between exposure to DAXI and any safety signals or antibody events. The most frequently reported treatment-related adverse events per treatment were muscular weakness (4.9%), injection-site pain (4.2%), and dysphagia (3.9%).
conclusionDAXI was safe and efficacious over repeated treatments in adults with CD. Adverse event rates were similar to or potentially lower compared with conventional BoNTs.
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