A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified March 2026 by Ipsen
Sponsor
Ipsen
Information Provided by (Responsible Party)
Ipsen
Clinicaltrials.gov Identifier
NCT06047444
Other Study ID Numbers:
CLIN-52120-463
First Submitted
September 13, 2023
First Posted
September 20, 2023
Last Update Posted
April 30, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Chronic Migraine
Biological: Botulinum toxin type ABiological: Botulinum toxin type AOther: PlaceboOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment759 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposePrevention
Official TitleA 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
Study Start DateOctober 11, 2023
Actual Primary Completion Date5d 12h from now
Actual Study Completion Date5mos 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Dysport® dose "A"
Participant will receive four treatment cycles, each separated by an interval of 12 weeks. Double-blind placebo-controlled (DBPC) Phase: Dysport® dose "A" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "A" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48)
Biological: Botulinum toxin type A
Dose "A" Unit/Injection (U/I), Intramuscular (IM) on every 12 weeks during a period of 36 weeks with a total of 4 injections.
Dysport® dose "B"
Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Dysport® dose "B" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "B" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48)
Biological: Botulinum toxin type A
Dose "A" Unit/Injection (U/I), Intramuscular (IM) on every 12 weeks during a period of 36 weeks with a total of 4 injections.
Placebo - Dysport dose "A"
Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Placebo dose "A" administered intramuscularly on Day 1 and Week 12 Extension Phase: Dysport® dose "A" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48)
Other: Placebo
"0" U/I, IM on Day 1 and Week 12 with a total of 2 injections.
Placebo - Dysport dose "B"
Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Placebo dose "B" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "B" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48).
Other: Placebo
"0" U/I, IM on Day 1 and Week 12 with a total of 2 injections.

Outcome Measures

Primary Outcome Measures
  1. Change from baseline at week 24 in monthly migraine days (MMD)
    The monthly migraine days (MMD) is assessed by eDiary, completed every day by the participant, to evaluate the efficacy of Dysport® compared to placebo.
Secondary Outcome Measures
  1. Change from baseline in MMD of ≥50%
    The monthly migraine days (MMD) is assessed by a daily eDiary.
  2. Change from baseline in MMD of ≥75%
    The monthly migraine days (MMD) is assessed by a daily eDiary.
  3. Cumulative number of MMD
    The cumulative number of monthly migraine days (MMD) is assessed by a daily eDiary.
  4. Change from baseline in MMD of moderate or severe intensity
    The intensity of MMD is assessed by a daily eDiary.
  5. Change from baseline in the number of MMD over the last 12 weeks prior to Week 24
    The monthly migraine days (MMD) is assessed by a daily eDiary.
  6. Change from baseline in monthly headache days (MHD) of moderate or severe intensity
    The intensity of monthly headache days (MHD) is assessed by a daily eDiary.
  7. Change from baseline in MHD of moderate or severe intensity of ≥50%
    The intensity of monthly headache days (MHD) is assessed by a daily eDiary.
  8. Change from baseline in MHD of moderate or severe intensity of ≥75%
    The intensity of monthly headache days (MHD) is assessed by a daily eDiary.
  9. Cumulative number of MHD of moderate or severe intensity
    The cumulative number of monthly headache days (MHD) is assessed by a daily eDiary.
  10. Change from baseline in the number of days per month of acute migraine medication intake
    The acute migraine specific medication intake will be recorded in the daily eDiary. Acute migraine medication is defined as triptan, ergotamine, gepant, or ditan.
  11. Headache medication overuser (yes, no)
    The headache medication overuse will be assessed by a concomitant medication log completed at each visit and acute medication taken to treat acute attack will be recorded in the daily eDiary. The headache medication overuse is defined as a participant with ≥10 days/month if ergotamine, triptan, gepant, ditan, opioid or combination analgesic, or ≥15 days/month if non-opioid analgesic (such as paracetamol, aspirin, NSAID)
  12. Use of acute migraine medication (yes or no)
    The use of acute migraine medication will be recorded in the daily eDiary.
  13. Patient's Global Impression of Change (PGIC) score
    The PGIC will be assessed by a questionnaire (7-point scale, score of 1 indicates very much improved and score of 7 indicates very much worse)
  14. Change from baseline of ≥1 and ≥2 grades in PGIC score
    The PGIC will be assessed by a questionnaire (7-point scale, score of 1 indicates very much improved and score of 7 indicates very much worse)
  15. Change from baseline in role function restrictive (RFR) domain of Migraine Specific Quality of Life (MSQ) Questionnaire
    The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)
  16. Change from baseline in role function-preventive (RFP) domain of MSQ Questionnaire
    The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)
  17. Change from baseline in emotional function (EF) domain of MSQ Questionnaire
    The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)
  18. Change from baseline in total MSQ score
    The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)
  19. Change in MSQ score to the minimally important change (MIC) thresholds
    The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)
  20. Change from baseline in total 6-item Headache Impact Test (HIT-6) score
    The HIT-6 will be assessed by a questionnaire (scores range from 36-78 and higher scores indicate a greater impact of headache on subject's life)
  21. Change from baseline in HIT-6 score to MIC thresholds
    The HIT-6 will be assessed by a questionnaire (scores range from 36-78 and higher scores indicate a greater impact of headache on subject's life)
  22. Change from baseline in Short Form 12 (SF-12) Questionnaire score
    The SF-12 will be assessed by a questionnaire (scores range from 0-100, with higher scores indicating better functioning)
  23. Chronic migraine status
    Chronic migraine status will be assessed by the daily eDiary and defined as number of participants with ≥15 MHD and ≥8 MMD
  24. Time to onset of effect
    Time to onset of effect is defined as the first time point post randomisation where MMD is reduced from baseline ≥50%
  25. Incidence of Treatment emergent adverse event (TEAEs)
    An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
  26. Percentage of Participants with clinically significant changes in vital signs
    Percentage of participants with clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
  27. Percentage of participants with clinically significant laboratory parameters (blood chemistry, haematology)
    Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will graded by the investigator.
  28. Treatment-emergence of suicidal ideation/suicidal behaviour
    It will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire that consists of 4 subscales: 1. Ideation severity subscale: questions answered yes/no, severity of ideation scored 1-5 with 5 being most severe 2. Intensity of ideation subscale : scores range from 2-25 with higher scores indicating more severe intensity of ideation. 3. Suicide behaviour subscale:4 types of suicidal behaviours are scored yes/no 4. Behaviour Lethality subscale: actual lethality/medical damage scores 0-5, with 5 being most severe ( death) and potential lethality scores 0-2 with 2 being more potentially lethal.
  29. Percentage of participants with binding antibodies to Dysport®
    Presence of binding antibodies will be assessed using a validated method of electrochemiluminescence assay (ECLA).
  30. Percentage of participants with neutralising antibodies to Dysport®
    It will be performed only for confirmed positive samples with ECLA (confirmation of the presence of binding antibodies). Presence of neutralizing antibodies will be assessed using a validated cell-based assay (CBA).

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion 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
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.

Contacts and Locations

Sponsors and CollaboratorsIpsen
Locations
Central Research Associates | Birmingham Alabama, United States, 35205CCT Research | Phoenix Arizona, United States, 85044HonorHealth Neurology | Scottsdale Arizona, United States, 85251Hope Clinical Research, LLC | Canoga Park California, United States, 91303Axiom Research LLC | Colton California, United States, 92324Fullerton Neurological Center | Fullerton California, United States, 92835Neurology Center of North Orange County | Fullerton California, United States, 92835The Los Angeles Headache Center | Los Angeles California, United States, 90067SDS Clinical Trials | Orange California, United States, 92868840011 | Palo Alto California, United States, 94304Stanford University School of Medicine - Stanford Cardiovascular Institute (CVI) | Palo Alto California, United States, 94304Alliance Clinical San Diego (Acclaim Clinical Research) | San Diego California, United States, 92120University of Colorado Hospital - Neurology Clinic | Aurora Colorado, United States, 80045Yale University School of Medicine | East Hartford Connecticut, United States, 06118Hasbani Neurology | New Haven Connecticut, United States, 06511New England Institute for Neurology and Headache (NEINH)/Medical Practice | Stamford Connecticut, United States, 06905Visionary Investigators Network (VIN) | Aventura Florida, United States, 33180Velocity Clinical Research - Hallandale Beach | Hallandale Florida, United States, 33009AGA Clinical Trials | Hialeah Florida, United States, 33012Infinity Clinical Research, LLC | Hollywood Florida, United States, 33024Neurology Clinical Research, Inc. | Hollywood Florida, United States, 33024Clinical Neuroscience Solutions Healthcare, Inc (CNS Healthcare, INC) | Jacksonville Florida, United States, 32256University of Miami Leonard M. Miller School of Medicine - Professional Arts Center | Miami Florida, United States, 33136Quantum Clinical Trials | Miami Beach Florida, United States, 33140Clinical Neuroscience Solutions, Inc ((CNS Healthcare) - Psychiatry) | Orlando Florida, United States, 32801Guardian Angel Research Center | Tampa Florida, United States, 33614USF Health-Morsani Center | Tampa Florida, United States, 33620Conquest Research | Winter Park Florida, United States, 32789Headache Wellness Center | Greensboro Georgia, United States, 27405Cedar Crosse Research Center | Chicago Illinois, United States, 60607Chicago Headache Center & Research | Chicago Illinois, United States, 60657Robbins Headache Clinic | Riverwoods Illinois, United States, 60015MD Fort Wayne Neurological Center | Fort Wayne Indiana, United States, 46804Comprehensive Neurology Services | Frederick Maryland, United States, 21702Boston Clinical Trials Inc | Boston Massachusetts, United States, 02131Beth Israel Deaconess Medical Center - Arnold Pain Management | Brookline Massachusetts, United States, 02115Neurology Center of NE,PC - Neurology | Foxborough Massachusetts, United States, 02035Mass Institute of Clinical Research | Westborough Massachusetts, United States, 01581New England Regional Headache Center, Inc. | Worcester Massachusetts, United States, 01609Quest Research Institute | Farmington Hills Michigan, United States, 48334Minneapolis Clinic of Neurology | Burnsville Minnesota, United States, 55337Papillion Research Center | Papillion Nebraska, United States, 68046WR-CRCN | Las Vegas Nevada, United States, 89106Alliance Clinical Las Vegas (Excel Clinical Research) | Las Vegas Nevada, United States, 89109Dent Neurosciences Research Center, Inc. | Amherst New York, United States, 14226SPRI Clinical Trials, LLC | Brooklyn New York, United States, 11235Nuvance Health Medical Practice | Poughkeepsie New York, United States, 12601Rochester Clinical Research | Rochester New York, United States, 14609Duke University Medical Center | Durham North Carolina, United States, 27705Blue Sky MD | Hendersonville North Carolina, United States, 28792Headache Center of Hope | Cincinnati Ohio, United States, 45236OrthoNeuro | New Albany Ohio, United States, 43054Helios Clinical Research | Wooster Ohio, United States, 44691Suburban Research Associates | Media Pennsylvania, United States, 19063Thomas Jefferson University Hospital - Jefferson Hospital for Neuroscience - Jefferson Neurology Associates - Neurology | Philadelphia Pennsylvania, United States, 19107Coastal Carolina Research Center - North Charleston | North Charleston South Carolina, United States, 29405Neurology Clinic, PC | Cordova Tennessee, United States, 38018KCA Neurology, PLLC | Franklin Tennessee, United States, 37067Helios Clinical Research LLC (Helios CR, Inc. Jackson TN) | Jackson Tennessee, United States, 38305Herzog, Steven MD | Dallas Texas, United States, 75214Texas Neurology | Dallas Texas, United States, 75214Zenos Clinical Research | Dallas Texas, United States, 75230Lone Star Neurology | Frisco Texas, United States, 75035Clinical Trial Network | Houston Texas, United States, 77074Research Your Health | Plano Texas, United States, 75093J. Lewis Research Inc.-Foothill | Salt Lake City Utah, United States, 84109Metrodora Institute | West Valley City Utah, United States, 84119Inova Medical Group - Neurology | Fairfax Virginia, United States, 22031MedStar Health - Department of Neurology | Columbia Washington, United States, 20010Frontier Clinical Research, LLC | Kingwood West Virginia, United States, 26537BCN Research, LLC | Greenfield Wisconsin, United States, 53228Neuroscience Group of Northeast Wisconsin-Neenah | Neenah Wisconsin, United States, 54956Centricity Research Halifax Multispecialty | Halifax , Canada, B3S 1N2Genge Partners Inc. | Montreal , Canada, CARe Clinic-Calgary | Red Deer , Canada, Bluewater Clinical Research Group Inc. | Sarnia , Canada, N7T 4X3Royal Julilee Hospital | Victoria , Canada, V8R 1J8Neurologie Brno s.r.o. | Brno , Czechia, Pratia Brno s.r.o. | Brno , Czechia, NeuropsychiatrieHK, s.r.o. | Hradec Králové , Czechia, Nemocnice Jihlava, p.o. | Jihlava , Czechia, Fakultni nemocnice Ostrava | Ostrava - Poruba , Czechia, Axon Clinical, s.r.o. | Prague , Czechia, DADO MEDICAL s.r.o. | Prague , Czechia, Fakultni Thomayerova nemocnice | Prague , Czechia, Institut neuropsychiatricke pece | Prague , Czechia, Ltd "Health" | Batumi , Georgia, 6010ISR-GEO Med Res Clin Healthycore | Tbilisi , Georgia, 0112"Pineo Medical Ecosystem" LTD | Tbilisi , Georgia, 0114LTD New Hospitals | Tbilisi , Georgia, 0114LTD S.Khechinashvili University Hospital | Tbilisi , Georgia, 0179Multprofil Clinic Consilium Medulla | Tbilisi , Georgia, 0186Charité - Universitätsmedizin Berlin KöR | Berlin , Germany, Emovis GmbH | Berlin , Germany, Universitätsmedizin Greifswald | Greifswald , Germany, Curiositas ad sanum Studien- und Beratungs GmbH Haag i.OB | Haag in Oberbayern , Germany, Vitos Orthopaedische Klinik Kassel | Kassel , Germany, LMU - Klinikum der Universität München - Campus Grosshadern | München , Germany, Ospedale Bellaria, IRCCS Istituto delle Scienze Neurologiche, AUSL di Bologna | Bologna , Italy, Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli | Naples , Italy, IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione | Pavia , Italy, Istituto Neurologico Mediterraneo - NEUROMED, Istituto di Ricovero e Cura a Carattere Scientifico | Pozzilli , Italy, IRCCS San Raffaele Pisana | Roma , Italy, PU Campus Bio-Medico di Roma | Roma , Italy, Centrum Medyczne Neuromed Pawel Lisewski | Bydgoszcz , Poland, Synexus Polska Sp. z o.o. | Gdynia , Poland, Centrum Medyczne Pratia Katowice | Katowice , Poland, Krakowska Akademia Neurologii Sp. z o.o. | Krakow , Poland, Krakowskie Centrum MedyczneSp.z o.o | Krakow , Poland, Pratia MCM Krakow | Krakow , Poland, Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej | Lublin , Poland, Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K. | Oświęcim , Poland, 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 Clinico Universitario De Valencia | Valencia , Spain, Hospital Universitario y Politécnico La Fe | Valencia , Spain, University Hospitals Sussex NHS Foundation Trust - Royal Sussex County Hospital | Brighton , United Kingdom, King's College Hospital (KCH) NHS Foundation Trust | Brixton , United Kingdom,
Investigators
Study Director: Ipsen Medical Director, Ipsen