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Evaluating Dysport® for Preventing Episodic Migraine in Adults

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study With Extension Phase to Evaluate the Efficacy and Safety of Dysport® for the Prevention of Episodic Migraine in Adult Participants

Phase 3 Interventional Ipsen · NCT06047457

This study is testing if Dysport®, a type of Botox, can help adults with episodic migraines have fewer headache days compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment714 (estimated)
Ages18 Years and up
SexAll
SponsorIpsen Industry-sponsored
Locations109 sites (Birmingham, Alabama and 108 other locations)
Trial IDNCT06047457 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of Dysport®, a formulation of Botulinum toxin type A, in preventing episodic migraines compared to a placebo. Participants will undergo a screening period followed by a 24-week treatment phase where they will receive either Dysport® or a placebo. The study focuses on adults diagnosed with episodic migraines, defined as having fewer than 15 headache days per month and at least 6 migraine days. The goal is to determine if Dysport® can reduce the frequency of migraine attacks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of episodic migraine for more than 12 months and a history of migraine attacks.

Not a fit: Patients who have not previously used preventive migraine treatments or have a different type of headache disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new preventive treatment option for adults suffering from episodic migraines.

How similar studies have performed: Other studies have shown promising results with Botulinum toxin type A for migraine prevention, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria :

* must be ≥18 years of age inclusive, at the time of signing the informed consent and privacy/data protection documentation.
* Participant has a diagnosis for more than 12 months, prior to screening visit, of migraine with aura or migraine without aura according to the International Classification of Headache Disorders definition and diagnostic criteria
* Migraine onset occurred when participant was \<50 years of age.
* Has baseline number of monthly headache days (MHD) of \<15 and baseline number of monthly migraine days (MMD) of ≥6, using eDiary data collected during the 4 weeks nearest to randomisation on Day 1 (but prior to randomisation).
* Has baseline number of valid diary days ≥22 days collected during the 4 weeks nearest to randomisation on Day 1.
* Participant must have previously used, or is currently using, preventive treatment for migraine (pharmacological) (i.e. non-naïve) prior to start of screening eDiary

Exclusion Criteria :

* History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache.
* Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache, which is permitted.
* Use of any of the following medications in the specified timeframe prior to start of the screening daily headache eDiary:

  * a. Within 24 weeks

    * i. Botulinum toxin for migraine (or for any other medical/aesthetic reason within 16 weeks)
  * b. Within 12 weeks

    * i. CGRP antagonists (monoclonal antibody or gepant) for preventive treatment of migraine (acute treatment of headache/migraine with a gepant is permitted, but limited to no more than 6 days per month (i.e. 6 days per each 4-week period with gepant intake))
    * ii. Cannabinol or other types of cannabinoids
  * c. Within 4 weeks

    * i. Anaesthetic or steroid injection in any region targeted for injection with study intervention
    * ii. Use of medical device to treat migraine (e.g. non-invasive neuromodulation therapies such as nerve stimulation (gammaCore), transcranial magnetic stimulation (cephaly), external trigeminal nerve stimulation, transcutaneous electrical nerve stimulation, and peripheral neuroelectrical stimulation)
    * iii. Other interventions for migraine assessed to interfere with study evaluations (e.g. acupuncture in head and neck region, cranial traction, nociceptive trigeminal inhibition, occipital nerve block treatments, and dental splints for headache) iv. Use of opioids or barbiturates for more than 2 days/month.

Note: participants are permitted to take one concomitant migraine preventative treatment (not listed above); however, the dose of this medication should be stable for ≥3 months before start of the screening eDiary.

• Known history of treatment failure to more than four medications prescribed for the prevention of migraine (two of which have different mechanisms of action) or known history of treatment failure to botulinum toxin prescribed for the prevention of migraine.

Where this trial is running

Birmingham, Alabama and 108 other locations

+59 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Episodic Migraine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.