A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults (E-BEOND)

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

The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing episodic migraine.

A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head, and is often accompanied by feeling or being sick and a sensitivity to bright lights and sound.

Episodic Migraine is defined as having less than 15 days of headache a month with at least 6 days with migraine headaches.

Migraines are caused by a series of events which cause the brain to get stimulated / activated, which results in the release of chemicals that cause pain.

Dysport® is a formulation of Botulinum toxin type A (BoNT-A), a medication that stops the release of these chemical messengers.

The study will consist of 3 periods:

1. A 'screening period' of 6 to 12 weeks to assess whether the participant can take part to the study and requires 1 visit.

2. A first Treatment Phase of 24 weeks. On Day 1 and at Week 12 of the first Treatment Phase, participants will receive injections into various muscles across the head, neck, face and shoulders.

   The injections will contain either a dose "A" or a dose ''B'' of Dysport® or a placebo (an inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied).

   Participants will make 4 visits to the clinic in person and have 4 remote (online) visits.

3. A second Treatment Phase of 24 weeks (extension phase). At Week 24 and at Week 36, all participants will get Dysport® (dose "A" or dose "B").

There will be 3 in person visits and 4 remote visits.

Participants will need to complete an e-diary and questionnaires throughout the study.

Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded.

The total study duration for a participant will be up to 60 weeks (approx. 14 months).

Study Overview

• Status: Active, not recruiting
• Conditions: Episodic Migraine
• Intervention / Treatment: Other: Placebo; Biological: Botulinum toxin type A; Biological: Botulinum toxin type A; Biological: Botulinum toxin type A; Biological: Botulinum toxin type A

• Study Type: Interventional
• Enrollment (Actual): 751
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Montreal, Canada, H3A 2B4
    • Genge Partners Inc.
  • Red Deer, Canada
    • CARe Clinic-Calgary
  • Sarnia, Canada, N7T 4X3
    • Bluewater Clinical Research Group Inc.
• Czechia
  • Brno, Czechia
    • Neurologie Brno s.r.o.
  • Brno, Czechia
    • Pratia Brno s.r.o.
  • Choceň, Czechia
    • NEUROHK s.r.o.
  • Jihlava, Czechia
    • Nemocnice Jihlava, p.o.
  • Ostrava, Czechia
    • Fakultni nemocnice Ostrava
  • Prague, Czechia
    • Axon Clinical, s.r.o.
  • Prague, Czechia
    • DADO MEDICAL s.r.o.
  • Prague, Czechia
    • Fakultni Thomayerova nemocnice
  • Prague, Czechia
    • Institut neuropsychiatricke pece
• France
  • Amiens, France
    • CHRU d'Amiens
  • Nîmes, France
    • CHU Nimes - Hôpital Caremeau
  • Paris, France
    • Assistance Publique-Hopitaux de Paris (AP-HP) - Unite de Recherche Clinique Saint-Louis Lariboisere-Ferd Widal
• Georgia
  • Batumi, Georgia, 6010
    • Ltd "Health"
  • Tbilisi, Georgia, 0114
    • LTD New Hospitals
  • Tbilisi, Georgia, 0179
    • LTD S.Khechinashvili University Hospital
  • Tbilisi, Georgia, 0114
    • "Pineo Medical Ecosystem" LTD
  • Tbilisi, Georgia, 0186
    • Multprofil Clinic Consilium Medulla
  • Tbilisi, Georgia
    • ISR-GEO Med Res Clin Healthycore
• Germany
  • Berlin, Germany
    • emovis GmbH
  • Berlin, Germany
    • Charité - Universitätsmedizin Berlin KöR
  • Greifswald, Germany
    • Universitätsmedizin Greifswald
  • Hessen, Germany
    • Kopfschmerzzentrum Frankfurt am Main
  • München, Germany
    • LMU - Klinikum der Universität München - Campus Grosshadern
• Poland
  • Bydgoszcz, Poland
    • Centrum Medyczne Neuromed Pawel Lisewski
  • Gdynia, Poland
    • Synexus Polska Sp. z o.o.
  • Katowice, Poland
    • Centrum Medyczne Pratia Katowice
  • Krakow, Poland
    • Krakowska Akademia Neurologii Sp. z o.o.
  • Krakow, Poland
    • Pratia MCM Krakow
  • Krakow, Poland
    • Krakowskie Centrum MedyczneSp.z o.o
  • Lublin, Poland
    • Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej
  • Oświęcim, Poland
    • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
• Spain
  • Barcelona, Spain
    • Hospital Universitari Vall d Hebron
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Complejo Hospitalario Ruber Juan Bravo
  • Málaga, Spain
    • Hospital Universitario Regional de Málaga
  • Valencia, Spain
    • Hospital Universitario y Politécnico La Fe
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates
  • Arizona
    • Phoenix, Arizona, United States, 85044
      • CCT Research
    • Scottsdale, Arizona, United States, 85251
      • HonorHealth Neurology
  • California
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, LLC
    • Colton, California, United States, 92324
      • Axiom Research LLC
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • Fullerton, California, United States, 92835
      • Fullerton Neurological Center
    • Orange, California, United States, 92868
      • SDS Clinical Trials
    • San Diego, California, United States, 92120
      • Alliance Clinical San Diego (Acclaim Clinical Research)
    • Savannah, California, United States, 31406
      • The Los Angeles Headache Center
  • Connecticut
    • East Hartford, Connecticut, United States, 06118
      • Yale University School of Medicine
    • New Haven, Connecticut, United States, 06511
      • Hasbani Neurology
    • Stamford, Connecticut, United States, 06905
      • New England Institute for Neurology and Headache (NEINH)/Medical Practice
  • Florida
    • Aventura, Florida, United States, 33180
      • Visionary Investigators Network (VIN)
    • Hallandale, Florida, United States, 33009
      • Velocity Clinical Research - Hallandale Beach
    • Hialeah, Florida, United States, 33012
      • Aga Clinical Trials
    • Hollywood, Florida, United States, 33024
      • Infinity Clinical Research, LLC
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions Healthcare, Inc (CNS Healthcare, INC)
    • Miami, Florida, United States, 33136
      • 840042
    • Miami Beach, Florida, United States, 33140
      • Quantum Clinical Trials
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc ((CNS Healthcare) - Psychiatry)
    • Tampa, Florida, United States, 33614
      • Guardian Angel Research Center
    • Winter Park, Florida, United States, 32789
      • Conquest Research
    • Winter Park, Florida, United States, 32131
      • Boston Clinical Trials Inc
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar Crosse Research Center
    • Chicago, Illinois, United States, 60657
      • Chicago Headache Center & Research Institute
    • Riverwoods, Illinois, United States, 60015
      • Robbins Headache Clinic
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • MD Fort Wayne Neurological Center
  • Maryland
    • Frederick, Maryland, United States, 21702
      • Comprehensive Neurology Services
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials Inc
    • Brookline, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center - Arnold Pain Management
    • Foxborough, Massachusetts, United States, 02035
      • Neurology Center of NE,PC - Neurology
    • Westborough, Massachusetts, United States, 01581
      • Lone Star Neurology,
    • Worcester, Massachusetts, United States, 01609
      • New England Regional Headache Center, Inc.
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Minneapolis Clinic of Neurology
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Clinical Research Professionals
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • M3 Wake Research - Las Vegas Wellness Way
    • Las Vegas, Nevada, United States, 89109
      • Alliance Clinical Las Vegas (Excel Clinical Research)
  • New York
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials, LLC
    • Poughkeepsie, New York, United States, 12601
      • Nuvance Health Medical Practice
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Asheville Neurology Specialists
    • Greensboro, North Carolina, United States, 27405
      • Headache Wellness Center
    • Hendersonville, North Carolina, United States, 28792
      • Blue Sky MD
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Headache Center of Hope
    • New Albany, Ohio, United States, 43054
      • OrthoNeuro
    • Wooster, Ohio, United States, 44691
      • Helios Clinical Research
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital - Jefferson Hospital for Neuroscience - Jefferson Neurology Associates - Neurology
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center - North Charleston
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Neurology Clinic, PC
    • Franklin, Tennessee, United States, 37067
      • KCA Neurology, PLLC
    • Jackson, Tennessee, United States, 38305
      • Helios Clinical Research LLC (Helios CR, Inc. Jackson TN)
  • Texas
    • Dallas, Texas, United States, 75230
      • Zenos Clinical Research
    • Dallas, Texas, United States, 75214
      • Herzog, Steven MD
    • Frisco, Texas, United States, 75035
      • Lone Star Neurology
    • Houston, Texas, United States, 77074
      • Clinical Trial Network
    • Plano, Texas, United States, 75093
      • Research Your Health
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research Inc.-Foothill
    • West Valley City, Utah, United States, 84119
      • Metrodora Institute
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Medical Group - Neurology
  • Washington
    • Columbia, Washington, United States, 20010
      • MedStar Health - Department of Neurology
  • West Virginia
    • Kingwood, West Virginia, United States, 26537
      • Frontier Clinical Research, LLC
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53228
      • BCN Research, LLC
    • Neenah, Wisconsin, United States, 54956
      • Neuroscience Group of Northeast Wisconsin-Neenah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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" U /Injection (U/I) , Intramuscular (IM) on every 12 weeks during a period of 36 weeks with a total of 4 injections.; Other Names: Dysport®; Biological: Botulinum toxin type A; Dose "B" U/I, IM on every 12 weeks during a period of 36 weeks with a total of 4 injections.; Other Names: Dysport®; Biological: Botulinum toxin type A; Dose "A" U/I, IM on Week 24 and Week 36 with a total of 2 injections.; Other Names: Dysport®; Biological: Botulinum toxin type A; Dose "B" U/I, IM on Week 24 and Week 36 with a total of 2 injections.; Other Names: Dysport®
Experimental: 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" U /Injection (U/I) , Intramuscular (IM) on every 12 weeks during a period of 36 weeks with a total of 4 injections.; Other Names: Dysport®; Biological: Botulinum toxin type A; Dose "B" U/I, IM on every 12 weeks during a period of 36 weeks with a total of 4 injections.; Other Names: Dysport®; Biological: Botulinum toxin type A; Dose "A" U/I, IM on Week 24 and Week 36 with a total of 2 injections.; Other Names: Dysport®; Biological: Botulinum toxin type A; Dose "B" U/I, IM on Week 24 and Week 36 with a total of 2 injections.; Other Names: Dysport®
Placebo Comparator: 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.; Biological: Botulinum toxin type A; Dose "A" U /Injection (U/I) , Intramuscular (IM) on every 12 weeks during a period of 36 weeks with a total of 4 injections.; Other Names: Dysport®; Biological: Botulinum toxin type A; Dose "B" U/I, IM on every 12 weeks during a period of 36 weeks with a total of 4 injections.; Other Names: Dysport®; Biological: Botulinum toxin type A; Dose "A" U/I, IM on Week 24 and Week 36 with a total of 2 injections.; Other Names: Dysport®; Biological: Botulinum toxin type A; Dose "B" U/I, IM on Week 24 and Week 36 with a total of 2 injections.; Other Names: Dysport®
Placebo Comparator: 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.; Biological: Botulinum toxin type A; Dose "A" U /Injection (U/I) , Intramuscular (IM) on every 12 weeks during a period of 36 weeks with a total of 4 injections.; Other Names: Dysport®; Biological: Botulinum toxin type A; Dose "B" U/I, IM on every 12 weeks during a period of 36 weeks with a total of 4 injections.; Other Names: Dysport®; Biological: Botulinum toxin type A; Dose "A" U/I, IM on Week 24 and Week 36 with a total of 2 injections.; Other Names: Dysport®; Biological: Botulinum toxin type A; Dose "B" U/I, IM on Week 24 and Week 36 with a total of 2 injections.; Other Names: Dysport®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in monthly migraine days (MMD)	The monthly migraine days (MMD) is assessed by a daily eDiary, completed by the participant, to evaluate the efficacy of Dysport® compared to placebo.	Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative number of MMD	The cumulative number of monthly migraine days (MMD) is assessed by a daily eDiary.	From Day 1 to Week 24
Change from baseline in MMD of moderate or severe intensity	The intensity of MMD is assessed by a daily eDiary.	Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
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.	Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
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.	Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
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.	Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Change from baseline in the number of days per month of acute migraine medication intake	The acute migraine medication intake will be recorded in the daily eDiary Acute migraine medication is defined as triptan, ergotamine, gepant, or ditan	Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
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)	Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Use of acute migraine medication (yes or no)	The use of acute migraine medication will be recorded in the daily eDiary.	Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
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%	From first time point post randomisation to Week 24
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.	Up to Week 24
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.	From baseline up to Week 24
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.	From baseline up to Week 24
Cumulative number of MHD of moderate to severe intensity	The cumulative number of monthly headache days (MHD) is assessed by a daily eDiary.	From Day 1 to Week 24
Change from baseline in MMD of ≥50%	The monthly migraine days (MMD) is assessed by a daily eDiary.	Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Change from baseline in MMD of ≥75%	The monthly migraine days (MMD) is assessed by a daily eDiary.	Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
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)	At Week 12 and Week 24
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)	At Week 12 and Week 24
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)	At Week 12 and Week 24
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)	At Week 12 and Week 24
Change from baseline to Chronic migraine status	Transition to Chronic migraine status will be assessed by the daily eDiary and defined as number of participants with ≥15 MHD and ≥8 MMD	At Week 24 (Week 21-24)
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: Ideation severity subscale: questions answered yes/no, severity of ideation scored 1-5 with 5 being most severe; Intensity of ideation subscale : scores range from 2-25 with higher scores indicating more severe intensity of ideation.; Suicide behaviour subscale:4 types of suicidal behaviours are scored yes/no; 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.	From baseline up to Week 24
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.	Weeks 13-24
PGIC score of grade ≥1 and ≥2	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)	At Week 12 and Week 24
Change from baseline in role function restrictive (RFR) domain of Migraine Specific Quality of Life Questionnaire (MSQ)	The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)	At Week 12 and Week 24
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)	At Week 12 and Week 24
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)	At Week 12 and Week 24
Change in MSQ score to the minimally important change (MIC)	The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)	At Week 12 and Week 24
Change in total 6-item Headache Impact Text (HIT-6) score to the 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)	At Week 12 and Week 24
Percentage of participants with binding antibodies to Dysport®	Presence of binding antibodies will be assessed using a validated method of electrochemiluminescence assay (ECLA).	At Week 24
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).	At Week 24

Collaborators and Investigators

• Sponsor: Ipsen
• Investigators: Study Director: Ipsen Medical Director, Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Estimated): May 27, 2026
• Study Completion (Estimated): November 6, 2026

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: CLIN-52120-464; 2023-504839-40-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
• IPD Sharing Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
• IPD Sharing Access Criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No