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
2 other identifiers
interventional
751
8 countries
105
Brief Summary
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.
- 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").
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2023
Typical duration for phase_3
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
September 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 6, 2026
May 1, 2026
April 1, 2026
2.7 years
September 14, 2023
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (30)
Change from baseline in MMD of ≥50%
Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Change from baseline in MMD of ≥75%
Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Cumulative number of MMD
From Day 1 to Week 24
Change from baseline in MMD of moderate or severe intensity
Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)
Change from baseline in the number of MMD over the last 12 weeks prior to Week 24
Weeks 13-24
- +25 more secondary outcomes
Study Arms (4)
Dysport® dose "A"
EXPERIMENTALParticipant 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)
Dysport® dose "B"
EXPERIMENTALParticipant 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)
Placebo - Dysport dose "A"
PLACEBO COMPARATORParticipant 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).
Placebo - Dysport dose "B"
PLACEBO COMPARATORParticipant 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).
Interventions
"0" U/I, IM on Day 1 and Week 12 with a total of 2 injections.
Dose "A" U /Injection (U/I) , Intramuscular (IM) on every 12 weeks during a period of 36 weeks with a total of 4 injections.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (105)
Central Research Associates
Birmingham, Alabama, 35205, United States
CCT Research
Phoenix, Arizona, 85044, United States
HonorHealth Neurology
Scottsdale, Arizona, 85251, United States
Hope Clinical Research, LLC
Canoga Park, California, 91303, United States
Axiom Research LLC
Colton, California, 92324, United States
Fullerton Neurological Center
Fullerton, California, 92835, United States
Neurology Center of North Orange County
Fullerton, California, 92835, United States
SDS Clinical Trials
Orange, California, 92868, United States
Alliance Clinical San Diego (Acclaim Clinical Research)
San Diego, California, 92120, United States
The Los Angeles Headache Center
Savannah, California, 31406, United States
Yale University School of Medicine
East Hartford, Connecticut, 06118, United States
Hasbani Neurology
New Haven, Connecticut, 06511, United States
New England Institute for Neurology and Headache (NEINH)/Medical Practice
Stamford, Connecticut, 06905, United States
Visionary Investigators Network (VIN)
Aventura, Florida, 33180, United States
Velocity Clinical Research - Hallandale Beach
Hallandale, Florida, 33009, United States
AGA Clinical Trials
Hialeah, Florida, 33012, United States
Infinity Clinical Research, LLC
Hollywood, Florida, 33024, United States
Clinical Neuroscience Solutions Healthcare, Inc (CNS Healthcare, INC)
Jacksonville, Florida, 32256, United States
840042
Miami, Florida, 33136, United States
Quantum Clinical Trials
Miami Beach, Florida, 33140, United States
Clinical Neuroscience Solutions, Inc ((CNS Healthcare) - Psychiatry)
Orlando, Florida, 32801, United States
Guardian Angel Research Center
Tampa, Florida, 33614, United States
Boston Clinical Trials Inc
Winter Park, Florida, 32131, United States
Conquest Research
Winter Park, Florida, 32789, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607, United States
Chicago Headache Center & Research Institute
Chicago, Illinois, 60657, United States
Robbins Headache Clinic
Riverwoods, Illinois, 60015, United States
MD Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804, United States
Comprehensive Neurology Services
Frederick, Maryland, 21702, United States
Boston Clinical Trials Inc
Boston, Massachusetts, 02131, United States
Beth Israel Deaconess Medical Center - Arnold Pain Management
Brookline, Massachusetts, 02115, United States
Neurology Center of NE,PC - Neurology
Foxborough, Massachusetts, 02035, United States
Lone Star Neurology,
Westborough, Massachusetts, 01581, United States
New England Regional Headache Center, Inc.
Worcester, Massachusetts, 01609, United States
Quest Research Institute
Farmington Hills, Michigan, 48334, United States
Minneapolis Clinic of Neurology
Burnsville, Minnesota, 55337, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
M3 Wake Research - Las Vegas Wellness Way
Las Vegas, Nevada, 89106, United States
Alliance Clinical Las Vegas (Excel Clinical Research)
Las Vegas, Nevada, 89109, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235, United States
Nuvance Health Medical Practice
Poughkeepsie, New York, 12601, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Asheville Neurology Specialists
Asheville, North Carolina, 28806, United States
Headache Wellness Center
Greensboro, North Carolina, 27405, United States
Blue Sky MD
Hendersonville, North Carolina, 28792, United States
Headache Center of Hope
Cincinnati, Ohio, 45236, United States
OrthoNeuro
New Albany, Ohio, 43054, United States
Helios Clinical Research
Wooster, Ohio, 44691, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Thomas Jefferson University Hospital - Jefferson Hospital for Neuroscience - Jefferson Neurology Associates - Neurology
Philadelphia, Pennsylvania, 19107, United States
Coastal Carolina Research Center - North Charleston
North Charleston, South Carolina, 29405, United States
Neurology Clinic, PC
Cordova, Tennessee, 38018, United States
KCA Neurology, PLLC
Franklin, Tennessee, 37067, United States
Helios Clinical Research LLC (Helios CR, Inc. Jackson TN)
Jackson, Tennessee, 38305, United States
Herzog, Steven MD
Dallas, Texas, 75214, United States
Zenos Clinical Research
Dallas, Texas, 75230, United States
Lone Star Neurology
Frisco, Texas, 75035, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Research Your Health
Plano, Texas, 75093, United States
J. Lewis Research Inc.-Foothill
Salt Lake City, Utah, 84109, United States
Metrodora Institute
West Valley City, Utah, 84119, United States
Inova Medical Group - Neurology
Fairfax, Virginia, 22031, United States
MedStar Health - Department of Neurology
Columbia, Washington, 20010, United States
Frontier Clinical Research, LLC
Kingwood, West Virginia, 26537, United States
BCN Research, LLC
Greenfield, Wisconsin, 53228, United States
Neuroscience Group of Northeast Wisconsin-Neenah
Neenah, Wisconsin, 54956, United States
Genge Partners Inc.
Montreal, H3A 2B4, Canada
CARe Clinic-Calgary
Red Deer, Canada
Bluewater Clinical Research Group Inc.
Sarnia, N7T 4X3, Canada
Neurologie Brno s.r.o.
Brno, Czechia
Pratia Brno s.r.o.
Brno, Czechia
NEUROHK s.r.o.
Choceň, Czechia
Nemocnice Jihlava, p.o.
Jihlava, Czechia
Fakultni nemocnice Ostrava
Ostrava, 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
CHRU d'Amiens
Amiens, France
CHU Nimes - Hôpital Caremeau
Nîmes, France
Assistance Publique-Hopitaux de Paris (AP-HP) - Unite de Recherche Clinique Saint-Louis Lariboisere-Ferd Widal
Paris, France
Ltd "Health"
Batumi, 6010, Georgia
"Pineo Medical Ecosystem" LTD
Tbilisi, 0114, Georgia
LTD New Hospitals
Tbilisi, 0114, Georgia
LTD S.Khechinashvili University Hospital
Tbilisi, 0179, Georgia
Multprofil Clinic Consilium Medulla
Tbilisi, 0186, Georgia
ISR-GEO Med Res Clin Healthycore
Tbilisi, Georgia
Charité - Universitätsmedizin Berlin KöR
Berlin, Germany
Emovis GmbH
Berlin, Germany
Universitätsmedizin Greifswald
Greifswald, Germany
Kopfschmerzzentrum Frankfurt am Main
Hessen, Germany
LMU - Klinikum der Universität München - Campus Grosshadern
München, Germany
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 Universitari Vall D Hebron
Barcelona, Spain
Complejo Hospitalario Ruber Juan Bravo
Madrid, Spain
Hospital Universitario 12 De Octubre
Madrid, Spain
Hospital Universitario Regional De Malaga
Málaga, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2023
First Posted
September 21, 2023
Study Start
September 29, 2023
Primary Completion (Estimated)
May 27, 2026
Study Completion (Estimated)
November 6, 2026
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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/).
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.