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New hope for migraine sufferers: dysport shots aim to cut headache days

NCT ID NCT06047444

Disease control Sponsor: Ipsen Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This study tests whether Dysport injections can prevent chronic migraines in adults. Chronic migraine means having at least 15 headache days per month, with 8 being migraines. Participants receive injections into head, neck, and shoulder muscles every 12 weeks for up to 60 weeks. The goal is to see if Dysport reduces the number of migraine days compared to a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

759 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: Within 24 weeks * i. Botulinum toxin for migraine (or for any other medical/aesthetic reason within 16 weeks) 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 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.

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic migraine

Contacts and locations

Locations

  • "Pineo Medical Ecosystem" LTD

    Tbilisi, 0114, Georgia

  • 840011

    Palo Alto, California, 94304, United States

  • AGA Clinical Trials

    Hialeah, Florida, 33012, United States

  • Alliance Clinical Las Vegas (Excel Clinical Research)

    Las Vegas, Nevada, 89109, United States

  • Alliance Clinical San Diego (Acclaim Clinical Research)

    San Diego, California, 92120, United States

  • Axiom Research LLC

    Colton, California, 92324, United States

  • Axon Clinical, s.r.o.

    Prague, Czechia

  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli

    Naples, Italy

  • BCN Research, LLC

    Greenfield, Wisconsin, 53228, United States

  • Beth Israel Deaconess Medical Center - Arnold Pain Management

    Brookline, Massachusetts, 02115, United States

  • Blue Sky MD

    Hendersonville, North Carolina, 28792, United States

  • Bluewater Clinical Research Group Inc.

    Sarnia, N7T 4X3, Canada

  • Boston Clinical Trials Inc

    Boston, Massachusetts, 02131, United States

  • CARe Clinic-Calgary

    Red Deer, Canada

  • CCT Research

    Phoenix, Arizona, 85044, United States

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607, United States

  • Central Research Associates

    Birmingham, Alabama, 35205, United States

  • Centricity Research Halifax Multispecialty

    Halifax, B3S 1N2, Canada

  • Centrum Medyczne Neuromed Pawel Lisewski

    Bydgoszcz, Poland

  • Centrum Medyczne Pratia Katowice

    Katowice, Poland

  • Charité - Universitätsmedizin Berlin KöR

    Berlin, Germany

  • Chicago Headache Center & Research

    Chicago, Illinois, 60657, United States

  • Clinical Neuroscience Solutions Healthcare, Inc (CNS Healthcare, INC)

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions, Inc ((CNS Healthcare) - Psychiatry)

    Orlando, Florida, 32801, United States

  • Clinical Trial Network

    Houston, Texas, 77074, United States

  • Coastal Carolina Research Center - North Charleston

    North Charleston, South Carolina, 29405, United States

  • Comprehensive Neurology Services

    Frederick, Maryland, 21702, United States

  • Conquest Research

    Winter Park, Florida, 32789, United States

  • Curiositas ad sanum Studien- und Beratungs GmbH Haag i.OB

    Haag in Oberbayern, Germany

  • DADO MEDICAL s.r.o.

    Prague, Czechia

  • Dent Neurosciences Research Center, Inc.

    Amherst, New York, 14226, United States

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Emovis GmbH

    Berlin, Germany

  • Fakultni Thomayerova nemocnice

    Prague, Czechia

  • Fakultni nemocnice Ostrava

    Ostrava - Poruba, Czechia

  • Frontier Clinical Research, LLC

    Kingwood, West Virginia, 26537, United States

  • Fullerton Neurological Center

    Fullerton, California, 92835, United States

  • Genge Partners Inc.

    Montreal, Canada

  • Guardian Angel Research Center

    Tampa, Florida, 33614, United States

  • Hasbani Neurology

    New Haven, Connecticut, 06511, United States

  • Headache Center of Hope

    Cincinnati, Ohio, 45236, United States

  • Headache Wellness Center

    Greensboro, Georgia, 27405, United States

  • Helios Clinical Research

    Wooster, Ohio, 44691, United States

  • Helios Clinical Research LLC (Helios CR, Inc. Jackson TN)

    Jackson, Tennessee, 38305, United States

  • Herzog, Steven MD

    Dallas, Texas, 75214, United States

  • HonorHealth Neurology

    Scottsdale, Arizona, 85251, United States

  • Hope Clinical Research, LLC

    Canoga Park, California, 91303, United States

  • Hospital Clinico Universitario De Valencia

    Valencia, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain

  • Hospital Universitario Regional De Malaga

    Málaga, Spain

  • Hospital Universitario Virgen De La Macarena

    Seville, Spain

  • Hospital Universitario y Politécnico La Fe

    Valencia, Spain

  • IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione

    Pavia, Italy

  • IRCCS San Raffaele Pisana

    Roma, Italy

  • ISR-GEO Med Res Clin Healthycore

    Tbilisi, 0112, Georgia

  • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej

    Lublin, Poland

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33024, United States

  • Inova Medical Group - Neurology

    Fairfax, Virginia, 22031, United States

  • Institut neuropsychiatricke pece

    Prague, Czechia

  • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.

    Oświęcim, Poland

  • Istituto Neurologico Mediterraneo - NEUROMED, Istituto di Ricovero e Cura a Carattere Scientifico

    Pozzilli, Italy

  • J. Lewis Research Inc.-Foothill

    Salt Lake City, Utah, 84109, United States

  • KCA Neurology, PLLC

    Franklin, Tennessee, 37067, United States

  • King's College Hospital (KCH) NHS Foundation Trust

    Brixton, United Kingdom

  • Krakowska Akademia Neurologii Sp. z o.o.

    Krakow, Poland

  • Krakowskie Centrum MedyczneSp.z o.o

    Krakow, Poland

  • LMU - Klinikum der Universität München - Campus Grosshadern

    München, Germany

  • LTD New Hospitals

    Tbilisi, 0114, Georgia

  • LTD S.Khechinashvili University Hospital

    Tbilisi, 0179, Georgia

  • Lone Star Neurology

    Frisco, Texas, 75035, United States

  • Ltd "Health"

    Batumi, 6010, Georgia

  • MD Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804, United States

  • Mass Institute of Clinical Research

    Westborough, Massachusetts, 01581, United States

  • MedStar Health - Department of Neurology

    Columbia, Washington, 20010, United States

  • Metrodora Institute

    West Valley City, Utah, 84119, United States

  • Minneapolis Clinic of Neurology

    Burnsville, Minnesota, 55337, United States

  • Multprofil Clinic Consilium Medulla

    Tbilisi, 0186, Georgia

  • Nemocnice Jihlava, p.o.

    Jihlava, Czechia

  • Neurologie Brno s.r.o.

    Brno, Czechia

  • Neurology Center of NE,PC - Neurology

    Foxborough, Massachusetts, 02035, United States

  • Neurology Center of North Orange County

    Fullerton, California, 92835, United States

  • Neurology Clinic, PC

    Cordova, Tennessee, 38018, United States

  • Neurology Clinical Research, Inc.

    Hollywood, Florida, 33024, United States

  • NeuropsychiatrieHK, s.r.o.

    Hradec Králové, Czechia

  • Neuroscience Group of Northeast Wisconsin-Neenah

    Neenah, Wisconsin, 54956, United States

  • New England Institute for Neurology and Headache (NEINH)/Medical Practice

    Stamford, Connecticut, 06905, United States

  • New England Regional Headache Center, Inc.

    Worcester, Massachusetts, 01609, United States

  • Nuvance Health Medical Practice

    Poughkeepsie, New York, 12601, United States

  • OrthoNeuro

    New Albany, Ohio, 43054, United States

  • Ospedale Bellaria, IRCCS Istituto delle Scienze Neurologiche, AUSL di Bologna

    Bologna, Italy

  • PU Campus Bio-Medico di Roma

    Roma, Italy

  • Papillion Research Center

    Papillion, Nebraska, 68046, United States

  • Pratia Brno s.r.o.

    Brno, Czechia

  • Pratia MCM Krakow

    Krakow, Poland

  • Quantum Clinical Trials

    Miami Beach, Florida, 33140, United States

  • Quest Research Institute

    Farmington Hills, Michigan, 48334, United States

  • Research Your Health

    Plano, Texas, 75093, United States

  • Robbins Headache Clinic

    Riverwoods, Illinois, 60015, United States

  • Rochester Clinical Research

    Rochester, New York, 14609, United States

  • Royal Julilee Hospital

    Victoria, V8R 1J8, Canada

  • SDS Clinical Trials

    Orange, California, 92868, United States

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235, United States

  • Stanford University School of Medicine - Stanford Cardiovascular Institute (CVI)

    Palo Alto, California, 94304, United States

  • Suburban Research Associates

    Media, Pennsylvania, 19063, United States

  • Synexus Polska Sp. z o.o.

    Gdynia, Poland

  • Texas Neurology

    Dallas, Texas, 75214, United States

  • The Los Angeles Headache Center

    Los Angeles, California, 90067, United States

  • Thomas Jefferson University Hospital - Jefferson Hospital for Neuroscience - Jefferson Neurology Associates - Neurology

    Philadelphia, Pennsylvania, 19107, United States

  • USF Health-Morsani Center

    Tampa, Florida, 33620, United States

  • University Hospitals Sussex NHS Foundation Trust - Royal Sussex County Hospital

    Brighton, United Kingdom

  • University of Colorado Hospital - Neurology Clinic

    Aurora, Colorado, 80045, United States

  • University of Miami Leonard M. Miller School of Medicine - Professional Arts Center

    Miami, Florida, 33136, United States

  • Universitätsmedizin Greifswald

    Greifswald, Germany

  • Velocity Clinical Research - Hallandale Beach

    Hallandale, Florida, 33009, United States

  • Visionary Investigators Network (VIN)

    Aventura, Florida, 33180, United States

  • Vitos Orthopaedische Klinik Kassel

    Kassel, Germany

  • WR-CRCN

    Las Vegas, Nevada, 89106, United States

  • Yale University School of Medicine

    East Hartford, Connecticut, 06118, United States

  • Zenos Clinical Research

    Dallas, Texas, 75230, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.