Ipsen's Dysport hits primary endpoint in Phase 3 episodic migraine trial
E-BEOND is the first Phase III trial of a botulinum toxin to show a statistically significant cut in monthly migraine days versus placebo in episodic migraine.
Executive Summary
- Ipsen's Phase III trial of Dysport in episodic migraine met its primary endpoint, reducing monthly migraine days against placebo, extending a positive result the company also reported in chronic migraine.
- No botulinum toxin has previously cleared a Phase III bar for statistical significance in episodic migraine, a population that is larger than the chronic migraine indication where Dysport-class toxins are already used.
- The disclosure is topline: the size of the migraine-day reduction, its statistical strength, and durability beyond week 24 are reserved for a future scientific presentation, which will determine how the result is weighed against oral and injectable preventives.
- A same-target, same-modality rival is running parallel Phase 3 trials in both migraine subtypes, so the result lands in a field with an active direct comparator rather than a mechanism working in isolation.
The disclosure
Ipsen announced on July 9, 2026 that E-BEOND (NCT06047457) met its primary endpoint, a statistically significant reduction in monthly migraine days for Dysport versus placebo at week 24. The trial enrolled 751 adults with episodic migraine, defined as up to 14 headache days per month with at least 6 migraine days, across sites in the United States, Canada, and six European countries. Ipsen paired the readout with a second Phase III trial, C-BEOND, in chronic migraine, which also met its primary endpoint on the same measure. The two trials together enrolled 1,510 patients across 120 centers. Dysport+1Dysport® is the first botulinum toxin to achieve positive topline Phase III results in both ...Jul 9, 2026A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in AdultsNCT06047457
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The stake
Christelle Huguet, Ipsen's EVP and Global Head of R&D, called the results "an advance in the development of botulinum toxin therapies for migraine" and said the program positions Dysport "as a potential first-in-class treatment for a broad migraine population". Cristina Tassorelli, principal investigator for C-BEOND, and Jessica Ailani, principal investigator for E-BEOND, both framed the results as expanding preventive options where they said choices remain limited, particularly for episodic migraine. Ipsen said Dysport's safety findings in both trials were consistent with its established use in approved indications, with no new signals identified. DysportDysport® is the first botulinum toxin to achieve positive topline Phase III results in both ...Jul 9, 2026
What the design tests
E-BEOND is a randomized, placebo-controlled Phase 3 trial with a single primary endpoint, change from baseline in monthly migraine days, and 25 secondary endpoints spanning headache-day reduction thresholds, quality-of-life scores, and acute medication use. Enrollment finished at 751 patients, exactly matching the trial's target, and the study moved to Active, not recruiting status in October 2025 once enrollment closed. The registry lists the primary completion date as May 27, 2026, following a series of date revisions during the trial's three-year enrollment period. Ipsen said full endpoint-level detail, including effect size and durability out to week 48 under an extension phase, will be presented at a future scientific congress rather than in the topline release. NCT06047457+1A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in AdultsNCT06047457Dysport® is the first botulinum toxin to achieve positive topline Phase III results in both ...Jul 9, 2026
The competitive field
Merz Pharmaceuticals is running an identical-target, identical-modality Phase 3 program with Xeomin in both episodic migraine (NCT07018700) and chronic migraine (NCT07018713), placing a direct comparator inside the same mechanism class rather than leaving Dysport's result unchallenged. Beyond botulinum toxins, episodic migraine prevention is also contested by CGRP-targeted oral and injectable therapies, including AbbVie's atogepant and Pfizer's rimegepant, which work through a different mechanism and are not displaced by this result. Within the botulinum-toxin class specifically, three sponsors have recorded Phase 3 failures in SNAP-25-targeted migraine programs, underscoring that a statistically significant primary endpoint in this class had not been established in episodic migraine before this trial. NCT06047457A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in AdultsNCT06047457
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.