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Episodic MigrainePhase 3E-BEONDNCT06047457

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

A Phase 3 study testing Botulinum toxin type A in people with Episodic Migraine, run by Ipsen at 105 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Episodic Migraine
What is being tested?
Botulinum toxin type A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
751 participants
Where
105 sitesin 8 countries
Study dates
29 Sep 2023to 16 Nov 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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
  • 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

Trial locations and contacts

105 sites in 8 countries.

105 sites in 8 countries

United States66 sites

  • Asheville Neurology Specialists

    Asheville, North Carolina, 28806

  • Visionary Investigators Network (VIN)

    Aventura, Florida, 33180

  • Central Research Associates

    Birmingham, Alabama, 35205

  • Boston Clinical Trials Inc

    Boston, Massachusetts, 02131

  • Beth Israel Deaconess Medical Center - Arnold Pain Management

    Brookline, Massachusetts, 02115

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235

  • Minneapolis Clinic of Neurology

    Burnsville, Minnesota, 55337

  • Hope Clinical Research, LLC

    Canoga Park, California, 91303

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • Chicago Headache Center & Research Institute

    Chicago, Illinois, 60657

  • Headache Center of Hope

    Cincinnati, Ohio, 45236

  • Axiom Research LLC

    Colton, California, 92324

  • MedStar Health - Department of Neurology

    Columbia, Washington, 20010

  • Neurology Clinic, PC

    Cordova, Tennessee, 38018

  • Herzog, Steven MD

    Dallas, Texas, 75214

  • Zenos Clinical Research

    Dallas, Texas, 75230

  • Yale University School of Medicine

    East Hartford, Connecticut, 06118

  • Inova Medical Group - Neurology

    Fairfax, Virginia, 22031

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • MD Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804

  • Neurology Center of NE,PC - Neurology

    Foxborough, Massachusetts, 02035

  • KCA Neurology, PLLC

    Franklin, Tennessee, 37067

  • Comprehensive Neurology Services

    Frederick, Maryland, 21702

  • Lone Star Neurology

    Frisco, Texas, 75035

  • Fullerton Neurological Center

    Fullerton, California, 92835

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • BCN Research, LLC

    Greenfield, Wisconsin, 53228

  • Headache Wellness Center

    Greensboro, North Carolina, 27405

  • Velocity Clinical Research - Hallandale Beach

    Hallandale, Florida, 33009

  • Blue Sky MD

    Hendersonville, North Carolina, 28792

  • AGA Clinical Trials

    Hialeah, Florida, 33012

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33024

  • Clinical Trial Network

    Houston, Texas, 77074

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

    Jackson, Tennessee, 38305

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

    Jacksonville, Florida, 32256

  • Frontier Clinical Research, LLC

    Kingwood, West Virginia, 26537

  • M3 Wake Research - Las Vegas Wellness Way

    Las Vegas, Nevada, 89106

  • Alliance Clinical Las Vegas (Excel Clinical Research)

    Las Vegas, Nevada, 89109

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • 840042

    Miami, Florida, 33136

  • Quantum Clinical Trials

    Miami Beach, Florida, 33140

  • Neuroscience Group of Northeast Wisconsin-Neenah

    Neenah, Wisconsin, 54956

  • OrthoNeuro

    New Albany, Ohio, 43054

  • Hasbani Neurology

    New Haven, Connecticut, 06511

  • Coastal Carolina Research Center - North Charleston

    North Charleston, South Carolina, 29405

  • SDS Clinical Trials

    Orange, California, 92868

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

    Orlando, Florida, 32801

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

    Philadelphia, Pennsylvania, 19107

  • CCT Research

    Phoenix, Arizona, 85044

  • Research Your Health

    Plano, Texas, 75093

  • Nuvance Health Medical Practice

    Poughkeepsie, New York, 12601

  • Robbins Headache Clinic

    Riverwoods, Illinois, 60015

  • Rochester Clinical Research

    Rochester, New York, 14609

  • J. Lewis Research Inc.-Foothill

    Salt Lake City, Utah, 84109

  • Alliance Clinical San Diego (Acclaim Clinical Research)

    San Diego, California, 92120

  • The Los Angeles Headache Center

    Savannah, California, 31406

  • HonorHealth Neurology

    Scottsdale, Arizona, 85251

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

    Stamford, Connecticut, 06905

  • Guardian Angel Research Center

    Tampa, Florida, 33614

  • Metrodora Institute

    West Valley City, Utah, 84119

  • Lone Star Neurology,

    Westborough, Massachusetts, 01581

  • Boston Clinical Trials Inc

    Winter Park, Florida, 32131

  • Conquest Research

    Winter Park, Florida, 32789

  • Helios Clinical Research

    Wooster, Ohio, 44691

  • New England Regional Headache Center, Inc.

    Worcester, Massachusetts, 01609

Other trials in United States

Czechia9 sites

  • Neurologie Brno s.r.o.

    Brno

  • Pratia Brno s.r.o.

    Brno

  • NEUROHK s.r.o.

    Choceň

  • Nemocnice Jihlava, p.o.

    Jihlava

  • Fakultni nemocnice Ostrava

    Ostrava

  • Axon Clinical, s.r.o.

    Prague

  • DADO MEDICAL s.r.o.

    Prague

  • Fakultni Thomayerova nemocnice

    Prague

  • Institut neuropsychiatricke pece

    Prague

Other trials in Czechia

Poland8 sites

  • Centrum Medyczne Neuromed Pawel Lisewski

    Bydgoszcz

  • Synexus Polska Sp. z o.o.

    Gdynia

  • Centrum Medyczne Pratia Katowice

    Katowice

  • Krakowska Akademia Neurologii Sp. z o.o.

    Krakow

  • Krakowskie Centrum MedyczneSp.z o.o

    Krakow

  • Pratia MCM Krakow

    Krakow

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

    Lublin

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

    Oświęcim

Other trials in Poland

Georgia6 sites

  • Ltd "Health"

    Batumi, 6010

  • "Pineo Medical Ecosystem" LTD

    Tbilisi, 0114

  • LTD New Hospitals

    Tbilisi, 0114

  • LTD S.Khechinashvili University Hospital

    Tbilisi, 0179

  • Multprofil Clinic Consilium Medulla

    Tbilisi, 0186

  • ISR-GEO Med Res Clin Healthycore

    Tbilisi

Other trials in Georgia

Germany5 sites

  • Charité - Universitätsmedizin Berlin KöR

    Berlin

  • Emovis GmbH

    Berlin

  • Universitätsmedizin Greifswald

    Greifswald

  • Kopfschmerzzentrum Frankfurt am Main

    Hessen

  • LMU - Klinikum der Universität München - Campus Grosshadern

    München

Other trials in Germany

Spain5 sites

  • Hospital Universitari Vall D Hebron

    Barcelona

  • Complejo Hospitalario Ruber Juan Bravo

    Madrid

  • Hospital Universitario 12 De Octubre

    Madrid

  • Hospital Universitario Regional De Malaga

    Málaga

  • Hospital Universitario y Politécnico La Fe

    Valencia

Other trials in Spain

Canada3 sites

  • Genge Partners Inc.

    Montreal, H3A 2B4

  • CARe Clinic-Calgary

    Red Deer

  • Bluewater Clinical Research Group Inc.

    Sarnia, N7T 4X3

Other trials in Canada

France3 sites

  • CHRU d'Amiens

    Amiens

  • CHU Nimes - Hôpital Caremeau

    Nîmes

  • Assistance Publique-Hopitaux de Paris (AP-HP) - Unite de Recherche Clinique Saint-Louis Lariboisere-Ferd Widal

    Paris

Other trials in France

About this study

Official title: 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.

Read more

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).

Being tested
Botulinum toxin type A, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum toxin type ABiological

    Also called Dysport®

    Dose "A" U /Injection (U/I) , Intramuscular (IM) on every 12 weeks during a period of 36 weeks with a total of 4 injections.

  • Botulinum toxin type ABiological

    Also called Dysport®

    Dose "B" U/I, IM on every 12 weeks during a period of 36 weeks with a total of 4 injections.

  • PlaceboOther

    "0" U/I, IM on Day 1 and Week 12 with a total of 2 injections.

  • Botulinum toxin type ABiological

    Also called Dysport®

    Dose "A" U/I, IM on Week 24 and Week 36 with a total of 2 injections.

  • Botulinum toxin type ABiological

    Also called Dysport®

    Dose "B" U/I, IM on Week 24 and Week 36 with a total of 2 injections.

Study groups in NCT06047457
Study groupRoleWhat they receive
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)
Receives: Biological: Botulinum toxin type A
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)
Receives: Biological: Botulinum toxin type A
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).
Receives: Other: Placebo; Biological: Botulinum toxin type A
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).
Receives: Other: Placebo; Biological: Botulinum toxin type A

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)

Secondary outcomes (30)

  1. Change from baseline in MMD of ≥50%

    The monthly migraine days (MMD) is assessed by a daily eDiary.

    Measured: Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)

  2. Change from baseline in MMD of ≥75%

    The monthly migraine days (MMD) is assessed by a daily eDiary.

    Measured: Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)

  3. Cumulative number of MMD

    The cumulative number of monthly migraine days (MMD) is assessed by a daily eDiary.

    Measured: From Day 1 to Week 24

  4. Change from baseline in MMD of moderate or severe intensity

    The intensity of MMD is assessed by a daily eDiary.

    Measured: Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)

  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.

    Measured: Weeks 13-24

  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.

    Measured: Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)

  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.

    Measured: Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)

  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.

    Measured: Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)

  9. Cumulative number of MHD of moderate to severe intensity

    The cumulative number of monthly headache days (MHD) is assessed by a daily eDiary.

    Measured: From Day 1 to Week 24

  10. 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

    Measured: Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)

  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)

    Measured: Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)

  12. Use of acute migraine medication (yes or no)

    The use of acute migraine medication will be recorded in the daily eDiary.

    Measured: Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)

  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)

    Measured: At Week 12 and Week 24

  14. 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)

    Measured: At Week 12 and Week 24

  15. 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)

    Measured: At Week 12 and Week 24

  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)

    Measured: At Week 12 and Week 24

  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)

    Measured: At Week 12 and Week 24

  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)

    Measured: At Week 12 and Week 24

  19. 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)

    Measured: At Week 12 and Week 24

  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)

    Measured: At Week 12 and Week 24

  21. 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)

    Measured: At Week 12 and Week 24

  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)

    Measured: At Week 12 and Week 24

  23. 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

    Measured: At Week 24 (Week 21-24)

  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%

    Measured: From first time point post randomisation to Week 24

  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.

    Measured: Up to Week 24

  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.

    Measured: From baseline up to Week 24

  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.

    Measured: From baseline up to Week 24

  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.

    Measured: From baseline up to Week 24

  29. Percentage of participants with binding antibodies to Dysport®

    Presence of binding antibodies will be assessed using a validated method of electrochemiluminescence assay (ECLA).

    Measured: At Week 24

  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).

    Measured: At Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start29 Sep 2023
  3. Primary completion1 Jun 2026
  4. Study completion16 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
751 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06047457
Sponsor's protocol ID
CLIN-52120-464
Other IDs
2023-504839-40-00, 2023
Acronym
E-BEOND
Status last verified
Sep 2026
First submitted
14 Sep 2023
Last updated
4 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Botulinum toxin type A in people with Episodic Migraine, run by Ipsen at 105 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Czechia, Poland, Georgia, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in monthly migraine days (MMD) (time frame: Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06047457.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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