Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine

Last updated: December 5, 2024
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Migraine (Adult)

Migraine (Pediatric)

Oral Facial Pain

Treatment

BOTOX

Placebo

Clinical Study ID

NCT05028569
M21-307
2021-001979-16
  • Ages 18-65
  • All Genders

Study Summary

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (ICHD 2018). Migraine can be further categorized according to the frequency of attacks as episodic migraine (EM) or chronic migraine (CM). This study will assess the effects of BOTOX in preventing migraine in adult participants with EM.

BOTOX is being developed for the prevention of migraine in adults with episodic migraine (EM). Participants will be enrolled in 3 different treatment groups. There is 1 in 3 chance that participants will be assigned to receive placebo. Approximately 777 adult participants with EM will be enrolled in approximately 125 sites across the world.

Participants will receive intramuscular injections (injected into the muscle) of BOTOX or Placebo on Week 0 and Week 12. Eligible participants will receive BOTOX on Week 24 and Week 36.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of migraine headache disorder meeting International Classification ofHeadache Disorders (ICHD)-3 diagnostic criteria for migraine with aura or migrainewithout aura for >= 12 months.

  • Onset of migraine before 50 years of age.

  • History of 6 to 14 migraine days/month in each of the 3 months prior to Visit 1.

  • Six to 14 migraine/probable migraine days during the 4-week screening/baselinephase.

  • Less than 15 headache days/month in each of the 3 months prior to Visit 1 and duringthe 4-week screening/baseline phase.

Exclusion

Exclusion Criteria:

  • Current diagnosis of chronic migraine according to ICHD-3.

  • History or current diagnosis of migraine with brainstem aura, retinal migraine,complications of migraine, chronic tension-type headache, trigeminal autonomiccephalalgias, hypnic headache, hemicrania continua, or new daily persistentheadache.

  • History of headache attributed to another disorder (e.g., cervical dystonia,craniotomy, head/neck trauma) with exception that medication overuse headache perICHD-3 criteria is allowed.

  • History of inadequate response to > 4 prophylactic treatment for migraine, 2 ofwhich have different mechanisms of action.

  • Female who is pregnant, breastfeeding, or considering becoming pregnant during thestudy or within 90 days after the last dose of study drug.

Study Design

Total Participants: 775
Treatment Group(s): 2
Primary Treatment: BOTOX
Phase: 3
Study Start date:
November 05, 2021
Estimated Completion Date:
November 06, 2024

Connect with a study center

  • CHAMP Clinic /ID# 231635

    Calgary, Alberta T3M 1M4
    Canada

    Site Not Available

  • Vancouver Island Health Authority /ID# 231992

    Victoria, British Columbia V8R 1J8
    Canada

    Site Not Available

  • Maritime Neurology /ID# 232048

    Halifax, Nova Scotia B3R 1V9
    Canada

    Site Not Available

  • Toronto Memory Program /ID# 240006

    Toronto, Ontario M3B 2S7
    Canada

    Site Not Available

  • Clinique Neuro Levis /ID# 232049

    Lévis, Quebec G6W 0M5
    Canada

    Site Not Available

  • Fakultní Nemocnice U Sv. Anny V Brně /ID# 232213

    Brno, Brno-mesto 656 91
    Czechia

    Site Not Available

  • Fakultni Nemocnice Ostrava /ID# 232211

    Ostrava, Ostrava-mesto 708 52
    Czechia

    Site Not Available

  • Fakultni nemocnice u sv. Anny v Brne /ID# 232213

    Brno, 656 91
    Czechia

    Site Not Available

  • Nemocnice Jihlava, prispevkova organizace /ID# 232164

    Jihlava, 586 01
    Czechia

    Site Not Available

  • Fakultni nemocnice Ostrava /ID# 232211

    Ostrava, 708 52
    Czechia

    Active - Recruiting

  • CLINTRIAL s.r.o. /ID# 232208

    Prague 10, 100 00
    Czechia

    Active - Recruiting

  • Clintrial s.r.o. /ID# 232208

    Prague 10, 100 00
    Czechia

    Site Not Available

  • Axon Clinical, s.r.o. /ID# 232212

    Praha, 140 00
    Czechia

    Site Not Available

  • DADO MEDICAL s.r.o. /ID# 232157

    Praha, 120 00
    Czechia

    Site Not Available

  • Fakultni Thomayerova nemocnice /ID# 232214

    Praha, 140 59
    Czechia

    Site Not Available

  • Universitaetsmedizin Rostock /ID# 232471

    Rostock, Mecklenburg-Vorpommern 18057
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 239283

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Schmerzklinik Kiel /ID# 232480

    Kiel, Schleswig-Holstein 24149
    Germany

    Site Not Available

  • Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 232472

    Berlin, 10117
    Germany

    Site Not Available

  • Praxis Dr. Stude /ID# 232477

    Bochum, 44787
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 239283

    Dresden, 01307
    Germany

    Site Not Available

  • Praxis Dr. Gendolla /ID# 232474

    Essen, 45133
    Germany

    Site Not Available

  • Universitaetsklinikum Essen /ID# 232478

    Essen, 45147
    Germany

    Site Not Available

  • Kopfschmerzzentrum Frankfurt /ID# 234066

    Frankfurt am Main, 65929
    Germany

    Site Not Available

  • Universitaetsklinikum Halle (Saale) /ID# 241506

    Halle (Saale), 06120
    Germany

    Site Not Available

  • Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 232475

    Kassel, 34131
    Germany

    Site Not Available

  • Neurologie Klinikum Großhadern /ID# 232479

    Munich, 81344
    Germany

    Site Not Available

  • Hillel Yaffe Medical Center /ID# 232122

    Hadera, H_efa 38100
    Israel

    Site Not Available

  • Rambam Health Care Campus /ID# 238732

    Haifa, H_efa 3109601
    Israel

    Site Not Available

  • Maccabi Healthcare Services /ID# 238605

    Kfar Saba, HaMerkaz 4420123
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center /ID# 232119

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center /ID# 232598

    Tel Aviv, Tel-Aviv 6423906
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center /ID# 232598

    Tel Aviv-Yafo, Tel-Aviv 6423906
    Israel

    Site Not Available

  • Shaare Zedek Medical Center /ID# 239485

    Jerusalem, Yerushalayim 91031
    Israel

    Site Not Available

  • AppleTree Clinics /ID# 245687

    Lodz, Lodzkie 90-349
    Poland

    Site Not Available

  • AppleTree Clinics /ID# 245687

    Łódź, Lodzkie 90-349
    Poland

    Site Not Available

  • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 232355

    Lublin, Lubelskie 20-582
    Poland

    Site Not Available

  • Linden Sp. z o.o. sp.k. /ID# 245685

    Krakow, Malopolskie 30-721
    Poland

    Site Not Available

  • Specjalistyczne Gabinety Sp. z o.o. /ID# 233526

    Krakow, Malopolskie 30-539
    Poland

    Site Not Available

  • Instytut Zdrowia Dr Boczarska-Jedynak Sp. Z O.O. Sp.K. /Id# 251857

    Oswiecim, Malopolskie 32-600
    Poland

    Site Not Available

  • Instytut Zdrowia Dr Boczarska Jedynak /ID# 251857

    Oświęcim, Malopolskie 32-600
    Poland

    Site Not Available

  • Instytut Zdrowia Dr Boczarska-Jedynak Sp. Z O.O. Sp.K. /Id# 251857

    Oświęcim, Malopolskie 32-600
    Poland

    Site Not Available

  • Warszawska Klinika Sp. z o.o. /ID# 240612

    Warszawa, Mazowieckie 02-119
    Poland

    Site Not Available

  • Silmedic Sp. z o.o. /ID# 232358

    Katowice, Slaskie 40-282
    Poland

    Site Not Available

  • Solumed Centrum Medyczne /ID# 238446

    Poznan, Wielkopolskie 60-529
    Poland

    Site Not Available

  • Linden /ID# 245685

    Cracow, 30-721
    Poland

    Active - Recruiting

  • Linden Sp. z o.o. sp.k. /ID# 245685

    Cracow, 30-721
    Poland

    Site Not Available

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 241887

    Wroclaw, 52-210
    Poland

    Site Not Available

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 241887

    Wrocław, 52-210
    Poland

    Site Not Available

  • Hospital Universitario Central de Asturias /ID# 232428

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 232270

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Clinica Universidad de Navarra - Pamplona /ID# 232270

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron /ID# 232268

    Barcelona, 08035
    Spain

    Site Not Available

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 233320

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital Universitario La Paz /ID# 232495

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valladolid /ID# 232272

    Valladolid, 47003
    Spain

    Site Not Available

  • Linkoping University Hospital /ID# 234040

    Linkoping, Ostergotlands Lan 581 85
    Sweden

    Site Not Available

  • Skaneuro Privatmottagning /ID# 232175

    Lund, Skane Lan 227 33
    Sweden

    Site Not Available

  • Neurology Clinic /ID# 234067

    Stockholm, Stockholms Lan 114 33
    Sweden

    Site Not Available

  • Optimuskliniken /ID# 232174

    Upplands Vasby, 194 61
    Sweden

    Site Not Available

  • Migrankliniken /ID# 240533

    Värnamo, 331 50
    Sweden

    Site Not Available

  • Hull University Teaching Hospitals NHS Trust /ID# 242763

    Hull, East Riding Of Yorkshire HU3 2JZ
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital /ID# 244870

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • NHS Highland /ID# 242855

    Inverness, IV2 3UJ
    United Kingdom

    Site Not Available

  • Walton Centre /ID# 242857

    Liverpool, L9 7LJ
    United Kingdom

    Site Not Available

  • St Pancras Clinical Research /ID# 242764

    London, EC2Y 8EA
    United Kingdom

    Site Not Available

  • Neurology and Neurodiagnostics of Alabama /ID# 231918

    Hoover, Alabama 35244-5700
    United States

    Site Not Available

  • Rehabilitation & Neurological Services /ID# 252441

    Huntsville, Alabama 35805-4046
    United States

    Site Not Available

  • Alea Research /ID# 233329

    Phoenix, Arizona 85012-2707
    United States

    Site Not Available

  • Barrow Neurological Institute /ID# 231799

    Phoenix, Arizona 85013-4407
    United States

    Site Not Available

  • Duplicate_Barrow Neurological Institute /ID# 231799

    Phoenix, Arizona 85013-4407
    United States

    Site Not Available

  • Clinical Endpoints /ID# 232625

    Scottsdale, Arizona 85258-4595
    United States

    Site Not Available

  • Tucson Neuroscience Research /ID# 232288

    Tucson, Arizona 85710-6152
    United States

    Site Not Available

  • Arkansas Clinical Research /ID# 231640

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Woodland International Research Group /ID# 231492

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Hope Clinical Research /ID# 232189

    Canoga Park, California 91303
    United States

    Site Not Available

  • Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351

    Encino, California 91316
    United States

    Site Not Available

  • Neuro Pain Medical Center /ID# 231478

    Fresno, California 93710-5473
    United States

    Site Not Available

  • Sun Valley Research Center /ID# 231350

    Imperial, California 92251-9401
    United States

    Site Not Available

  • Collaborative Neuroscience Research - Long Beach /ID# 231608

    Long Beach, California 90806
    United States

    Site Not Available

  • Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 231908

    Los Alamitos, California 90720-3500
    United States

    Site Not Available

  • Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 231908

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 231337

    Newport Beach, California 92660
    United States

    Site Not Available

  • Excell Research, Inc /ID# 231334

    Oceanside, California 92056
    United States

    Site Not Available

  • Artemis Institute for Clinical Research - San Diego /ID# 231103

    San Diego, California 92103-2204
    United States

    Site Not Available

  • Colorado Springs Neurological Associates (CSNA) /ID# 230662

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Summit Headache and Neurologic Institute /ID# 231809

    Englewood, Colorado 80113-3781
    United States

    Site Not Available

  • Advanced Neurosciences Research, LLC /ID# 230658

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • New England Institute for Clinical Research /ID# 230656

    Stamford, Connecticut 06905-1224
    United States

    Site Not Available

  • Georgetown University Hospital /ID# 232129

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Neurology Offices of South Florida, PLLC /ID# 232281

    Boca Raton, Florida 33428-2231
    United States

    Site Not Available

  • Nova Clinical Research, LLC /ID# 245256

    Bradenton, Florida 34209-4616
    United States

    Site Not Available

  • Velocity Clinical Research - Hallandale Beach /ID# 232442

    Hallandale Beach, Florida 33009-4427
    United States

    Site Not Available

  • CNS Healthcare - Jacksonville /ID# 231345

    Jacksonville, Florida 32256-6039
    United States

    Site Not Available

  • Brainstorm Research /ID# 243825

    Miami, Florida 33176-2315
    United States

    Site Not Available

  • The Neurology Research Group /ID# 243825

    Miami, Florida 33176-2315
    United States

    Active - Recruiting

  • Sensible Healthcare /ID# 231340

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc /ID# 231362

    Orlando, Florida 32801-2986
    United States

    Site Not Available

  • Pain Relief Centers /ID# 232415

    Sun City Center, Florida 33573-6828
    United States

    Site Not Available

  • Accel Research Sites - Tampa Clinical Research Unit /ID# 231670

    Tampa, Florida 33634
    United States

    Site Not Available

  • Olympian Clinical Research - Tampa /ID# 239519

    Tampa, Florida 33615
    United States

    Site Not Available

  • University of South Florida /ID# 231808

    Tampa, Florida 33612
    United States

    Site Not Available

  • University of South Florida- Neuroscience Institute /ID# 231808

    Tampa, Florida 33613
    United States

    Site Not Available

  • Premiere Research Institute - Palm Beach /ID# 230646

    West Palm Beach, Florida 33407-3209
    United States

    Site Not Available

  • Conquest Research /ID# 232604

    Winter Park, Florida 32789
    United States

    Site Not Available

  • NeuroTrials Research Inc. /ID# 230639

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Accel Research Sites Neurostudies /ID# 230665

    Decatur, Georgia 30030-2627
    United States

    Site Not Available

  • CenExcel iResearch LLC /ID# 231335

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Clinical Research Institute /ID# 239517

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Northwest Clinical Trials /ID# 230657

    Boise, Idaho 83704
    United States

    Site Not Available

  • Velocity Clinical Research - Boise /ID# 230660

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Robbins Headache Clinic /ID# 230970

    Riverwoods, Illinois 60015-5711
    United States

    Site Not Available

  • Josephson-Wallack-Munshower Neurology - NE /ID# 230654

    Indianapolis, Indiana 46256-4692
    United States

    Active - Recruiting

  • Josephson-Wallack-Munshower Neurology - Northeast /ID# 230654

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • Josephson-Wallack-Munshower Neurology - PC /ID# 230654

    Indianapolis, Indiana 46256-4692
    United States

    Site Not Available

  • Deaconess Clinic - Gateway Health Center /ID# 231329

    Newburgh, Indiana 47630
    United States

    Site Not Available

  • Accellacare /ID# 231496

    Ames, Iowa 50010
    United States

    Site Not Available

  • Kansas Institute of Research /ID# 231862

    Overland Park, Kansas 66211-1363
    United States

    Site Not Available

  • Ochsner Clinic Foundation /ID# 230645

    Covington, Louisiana 70433-8107
    United States

    Site Not Available

  • Boston Clinical Trials /ID# 231367

    Boston, Massachusetts 02131-2515
    United States

    Site Not Available

  • Brigham and Women's Faulkner Hospital /ID# 231865

    Boston, Massachusetts 02130-3446
    United States

    Site Not Available

  • Michigan Headache & Neurological Institute (MHNI) /ID# 230659

    Ann Arbor, Michigan 48104-5131
    United States

    Site Not Available

  • Minneapolis Clinic of Neurology - Burnsville /ID# 231780

    Burnsville, Minnesota 55337-6732
    United States

    Site Not Available

  • StudyMetrix Research /ID# 230642

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Clinvest Research LLC /ID# 252440

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Excel Clinical Research /ID# 232188

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Las Vegas Clinical Trials /ID# 232628

    North Las Vegas, Nevada 89030-7187
    United States

    Site Not Available

  • Albuquerque Clinical Trials, Inc /ID# 231101

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Albuquerque Clinical Trials, Inc. /ID# 231101

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Dent Neurosciences Research Center, Inc. /ID# 252442

    Amherst, New York 14226
    United States

    Site Not Available

  • Montefiore Headache Center /ID# 232130

    Bronx, New York 10461-2720
    United States

    Site Not Available

  • Fieve Clinical Research, Inc. /ID# 231365

    New York, New York 10017-1921
    United States

    Site Not Available

  • Upstate Clinical Research Associates /ID# 231343

    Williamsville, New York 14221-6046
    United States

    Site Not Available

  • Headache Wellness Center /ID# 230819

    Greensboro, North Carolina 27405
    United States

    Site Not Available

  • M3 Wake Research Inc. /ID# 232285

    Raleigh, North Carolina 27612-8106
    United States

    Site Not Available

  • Neurology - Triad /ID# 231733

    Winston-Salem, North Carolina 27103-6984
    United States

    Site Not Available

  • Duplicate_University Of Cincinnati Medical Center /ID# 231739

    Cincinnati, Ohio 45267-0585
    United States

    Site Not Available

  • University of Cincinnati /ID# 231739

    Cincinnati, Ohio 45267-0585
    United States

    Site Not Available

  • Cutting Edge Research Group /ID# 231095

    Oklahoma City, Oklahoma 73116-1423
    United States

    Site Not Available

  • IPS Research Company /ID# 231085

    Oklahoma City, Oklahoma 73106
    United States

    Site Not Available

  • Lynn Health Science Institute (LHSI) /ID# 231349

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Lynn Institute of Oklahoma City /ID# 231349

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Sooner Clinical Research /ID# 231096

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • Abington Neurological Associates - Abington /ID# 231798

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • Lehigh Center for Clinical Research /ID# 231355

    Allentown, Pennsylvania 18104
    United States

    Site Not Available

  • Suburban Research Associates - Media /ID# 231354

    Media, Pennsylvania 19063-1760
    United States

    Site Not Available

  • Jefferson Hospital for Neuroscience /ID# 230664

    Philadelphia, Pennsylvania 19107-5191
    United States

    Site Not Available

  • Frontier Clinical Research /ID# 232623

    Smithfield, Pennsylvania 15478
    United States

    Site Not Available

  • Clinical Trials of SC /ID# 231369

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Coastal Carolina Research Center - North Charleston /ID# 231353

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Coastal Carolina Research Center /ID# 231353

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Clinical Neuroscience Solutions - Memphis /ID# 231328

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Nashville Neuroscience Group /ID# 231642

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Austin Clinical Trial Partners /ID# 231092

    Austin, Texas 78737
    United States

    Site Not Available

  • Texas Neurology /ID# 230661

    Dallas, Texas 75214
    United States

    Site Not Available

  • NeuroCare Plus /ID# 252499

    Houston, Texas 77094-1385
    United States

    Site Not Available

  • Charlottesville Medical Research /ID# 231368

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Integrated Neurology Services - Falls Church /ID# 244776

    Falls Church, Virginia 22043-2367
    United States

    Site Not Available

  • Sentara Neurology Specialists - Virginia Beach /ID# 231341

    Virginia Beach, Virginia 23456-0019
    United States

    Site Not Available

  • Tidewater Integr Med Research /ID# 231359

    Virginia Beach, Virginia 23451
    United States

    Site Not Available

  • Northwest Clinical Research Center /ID# 231336

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Puget Sound Neurology /ID# 230640

    Tacoma, Washington 25328
    United States

    Site Not Available

  • Frontier Clinical Research - Kingwood /ID# 234127

    Kingwood, West Virginia 26537-9797
    United States

    Site Not Available

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