Trial reportAdvances in therapy2026
A Phase IV, Randomized, Double-Blind, Crossover Study to Compare the Clinical Safety and Efficacy of AbobotulinumtoxinA and OnabotulinumtoxinA in Adult Upper Limb Spasticity.
Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04936542 (A Multicentre, Interventional, Post-marketing, Randomised, Double-blind, Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA), which is not on this map. Not yet cited in PubMed.
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A Multicentre, Interventional, Post-marketing, Randomised, Double-blind, Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport®) in Comparison With OnabotulinumtoxinA (Botox®) When Treating Adults With Upper Limb Spasticity
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Authors and funding
10 authors.
Funding
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Abstract
introductionLack of head-to-head comparative safety and efficacy data for abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) represented an important gap for informed spasticity management. This study compared the safety and efficacy of aboBoNT-A and onaBoNT-A for upper limb spasticity (ULS).
methodsDIRECTION (NCT04936542), a phase IV, randomized, double-blind, crossover study, involved 72 sites. Patients stratified by botulinum toxin A status (naïve/non-naïve) were randomized (1:1) to aboBoNT-A 900U followed by onaBoNT-A 360U (one cycle each), or vice versa. Muscles (wrist/finger flexors, biceps brachii) were injected with a fixed volume, using instrument-guided injection techniques. Participants fulfilling retreatment criteria received a second cycle at Week 12; otherwise, they were reassessed every 4 weeks (to Week 24) until requiring retreatment. Primary analyses tested non-inferiority based on treatment-emergent adverse events (TEAEs) from injection to Week 12 using a 5% non-inferiority margin [non-inferiority demonstrated if upper bound of the 80% confidence interval (CI) of the adjusted difference in TEAE rates was < 5%]. Secondary analyses compared duration of response based on time to symptom re-emergence.
resultsOverall, 464 patients [mean (standard deviation) age 56.8 (13.1) years, 34.1% female] were randomized (aboBoNT-A → onaBoNT-A [n = 231]; onaBoNT-A → aboBoNT-A [n = 233)]. Baseline characteristics were similar in both sequence arms. Adjusted rate of TEAEs for aboBoNT-A (20.3%) was non-inferior to onaBoNT-A (23.0%); adjusted difference (aboBoNT-A - onaBoNT-A) was - 2.7% (80%CI - 6.2%, 0.9%). Adjusted mean duration of response was 99.3 days for aboBoNT-A and 96.3 days for onaBoNT-A; adjusted difference of 3.0 (80%CI 0.2, 5.9) days favoring aboBoNT-A (p = 0.17; statistically significant under the pre-specified α = 0.20 framework). Longer duration of response with aboBoNT-A versus onaBoNT-A was seen across most subgroups over a fixed-interval follow-up.
conclusionIn this first head-to-head study of aboBoNT-A and onaBoNT-A in ULS, the aboBoNT-A TEAE rate was non-inferior to onaBoNT-A. At 90% of the maximum unit dose for adult ULS in the approved label for each formulation, duration of response was 3 days longer with aboBoNT-A than onaBoNT-A. These findings may support informed therapeutic decision-making.
trial registrationClinicalTrials.gov: NCT04936542; EudraCT: 2023-509196-16-00.
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