Ipsen Reports Head-to-Head Trial Results Comparing Dysport and Botox for Upper Limb Spasticity
Ipsen announced results from a Phase IV trial that compared Dysport and Botox in adults with upper limb spasticity. The study met its primary safety endpoint and a secondary efficacy endpoint showing longer duration of response for Dysport.
medpagetoday.comIpsen announced results from the DIRECTION trial, a Phase IV head-to-head study comparing Dysport (abobotulinumtoxinA) and Botox (onabotulinumtoxinA) in adults with upper limb spasticity. The data will be presented as a late-breaking session at the International Society of Physical and Rehabilitation Medicine world congress in Vancouver on May 19, 2026.
The randomized, double-blind, crossover trial enrolled 464 participants at 72 sites in the United States, France, and Canada. Patients had an average age of 57 years, two-thirds were male, and most had spasticity following a stroke. Each participant received one treatment cycle with each product.
0 percent for Botox. 9 percent, meeting the criterion for non-inferiority. 8 weeks for Botox. 20.
Statements "Today, for the first time, we have comparative evidence that distinguishes the performance of two widely used botulinum toxin treatments in patients with spasticity," said Dr. Alberto Esquenazi, DIRECTION Principal Investigator. "Ipsen is committed to generating robust clinical evidence that supports scientific understanding and real-world practice," said Sandra Silvestri, Chief Medical Officer at Ipsen.
" The findings address a gap in direct comparative data between the two treatments and are consistent with prior real-world observations of longer-lasting effects with Dysport.
Key Facts
Potential Impact
- 01
Ipsen gains additional comparative evidence for Dysport marketing and regulatory discussions.
- 02
Clinicians may consider duration data when selecting botulinum toxin treatments for spasticity.
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