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Evaluating Dysport® for Preventing Chronic 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 Chronic Migraine in Adult Participants

Phase 3 Interventional Ipsen · NCT06047444

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

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment720 (estimated)
Ages18 Years and up
SexAll
SponsorIpsen Industry-sponsored
Locations119 sites (Birmingham, Alabama and 118 other locations)
Trial IDNCT06047444 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 chronic 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. Chronic migraine is characterized by having at least 15 headache days per month, with at least 8 of those being migraine days. The study will collect data on the frequency of migraines and the overall impact on participants' quality of life.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of chronic migraine for over a year and a history of preventive treatment.

Not a fit: Patients with a history or current diagnosis of migraine that does not meet the chronic criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency and severity of chronic migraines for patients.

How similar studies have performed: Previous studies have shown that Botulinum toxin type A can be effective in treating chronic migraines, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria :

* Participant 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 chronic migraine 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) ≥15 and baseline number of monthly migraine days (MMD) of ≥8, 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:

  1. Within 24 weeks

     * i. Botulinum toxin for migraine (or for any other medical/aesthetic reason within 16 weeks)
  2. 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. Cannabidiol or other types of cannabinoids
  3. 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 118 other locations

+69 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 Chronic 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.