A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults
Launched by IPSEN · Sep 14, 2023
Trial Information
Current as of June 02, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how effective and safe a medication called Dysport® is in preventing chronic migraines in adults. Chronic migraines are defined as having at least 15 headache days a month, with at least 8 of those days being migraine attacks. The trial will compare Dysport® to a placebo (a treatment with no active ingredients) to see if it helps reduce the number of migraine days.
To participate in this study, you need to be at least 18 years old and have been diagnosed with chronic migraines for more than a year. You should experience a significant number of headache days each month. Over the course of about 14 months, participants will receive injections of either Dysport® or a placebo, visit the clinic several times, and keep track of their headaches using an online diary. Additionally, participants will undergo some medical tests and evaluations to monitor their health during the study. If you are interested, be sure to check with the study team about any medications you may be taking, as some might affect your eligibility.
Gender
ALL
Eligibility 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.
About Ipsen
Ipsen is a global biopharmaceutical group dedicated to innovation and specialty care, focusing on the discovery, development, and commercialization of transformative medicines for patients with serious diseases. With a strong emphasis on oncology, neuroscience, and rare diseases, Ipsen leverages cutting-edge research and advanced technologies to deliver high-quality therapies that address unmet medical needs. Committed to scientific excellence and ethical practices, Ipsen collaborates with healthcare professionals and stakeholders to drive patient-centered solutions and improve health outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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Media, Pennsylvania, United States
Berlin, , Germany
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Chicago, Illinois, United States
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New Albany, Ohio, United States
Córdoba, , Spain
Amherst, New York, United States
Farmington Hills, Michigan, United States
Greifswald, , Germany
Zaragoza, , Spain
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Valencia, , Spain
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Katowice, , Poland
Amherst, New York, United States
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Colton, California, United States
Chesterfield, Missouri, United States
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Jihlava, , Czechia
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Franklin, Tennessee, United States
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Kraków, , Poland
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New Haven, Connecticut, United States
Red Deer, , Canada
Berlin, , Germany
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West Valley City, Utah, United States
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Kingwood, West Virginia, United States
Tbilisi, , Georgia
Pavia, , Italy
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Fort Wayne, Indiana, United States
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Tbilisi, , Georgia
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Tempe, Arizona, United States
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Tbilisi, , Georgia
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Montréal, , Canada
Victoria, , Canada
Los Angeles, California, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tempe, Arizona, United States
Fullerton, California, United States
Fullerton, California, United States
Los Angeles, California, United States
Orange, California, United States
Palo Alto, California, United States
Aurora, Colorado, United States
Aventura, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Riverwoods, Illinois, United States
Fort Wayne, Indiana, United States
Boston, Massachusetts, United States
Burnsville, Minnesota, United States
Chesterfield, Missouri, United States
Papillion, Nebraska, United States
Las Vegas, Nevada, United States
Amherst, New York, United States
Brooklyn, New York, United States
Poughkeepsie, New York, United States
Rochester, New York, United States
Hendersonville, North Carolina, United States
New Albany, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Cordova, Tennessee, United States
Frisco, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
Salt Lake City, Utah, United States
West Valley City, Utah, United States
Columbia, Washington, United States
Halifax, , Canada
Montréal, , Canada
Red Deer, , Canada
Sarnia, , Canada
Brno, , Czechia
Brno, , Czechia
Jihlava, , Czechia
Ostrava Poruba, , Czechia
Praha 4, , Czechia
Praha 5, , Czechia
Praha 8, , Czechia
Praha, , Czechia
Batumi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Berlin, , Germany
Berlin, , Germany
Greifswald, , Germany
Haag In Oberbayern, , Germany
Kassel, , Germany
München, , Germany
Bologna, , Italy
Napoli, , Italy
Pavia, , Italy
Pozzilli, , Italy
Roma, , Italy
Roma, , Italy
Bydgoszcz, , Poland
Gdynia, , Poland
Katowice, , Poland
Kraków, , Poland
Kraków, , Poland
Kraków, , Poland
Lublin, , Poland
Oswiecim, , Poland
Córdoba, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Sevilla, , Spain
Valencia, , Spain
Valencia, , Spain
Zaragoza, , Spain
Brighton, , United Kingdom
Brixton, , United Kingdom
Napoli, , Italy
Westborough, Massachusetts, United States
Farmington Hills, Michigan, United States
Durham, North Carolina, United States
North Charleston, South Carolina, United States
Fairfax, Virginia, United States
Victoria, , Canada
Hradec Králové, , Czechia
Greensboro, Georgia, United States
Frederick, Maryland, United States
Worcester, Massachusetts, United States
Media, Pennsylvania, United States
Dallas, Texas, United States
Roma, , Italy
Kingwood, West Virginia, United States
Tampa, Florida, United States
Greensboro, Georgia, United States
Chicago, Illinois, United States
Frederick, Maryland, United States
Frederick, Maryland, United States
Worcester, Massachusetts, United States
New Albany, Ohio, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Red Deer, , Canada
Sarnia, , Canada
Victoria, , Canada
Brno, , Czechia
Brno, , Czechia
Hradec Králové, , Czechia
Praha 4, , Czechia
Praha 5, , Czechia
Praha 8, , Czechia
Praha, , Czechia
Haag In Oberbayern, , Germany
Kassel, , Germany
München, , Germany
Bologna, , Italy
Pozzilli, , Italy
Bydgoszcz, , Poland
Gdynia, , Poland
Kraków, , Poland
Lublin, , Poland
Oswiecim, , Poland
Brighton, , United Kingdom
Brixton, , United Kingdom
Jacksonville, Florida, United States
Orlando, Florida, United States
Wooster, Ohio, United States
Jackson, Tennessee, United States
Patients applied
Trial Officials
Ipsen Medical Director
Study Director
Ipsen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported