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

NCT05028569 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: M21-3072021-001979-16
• Study Type: interventional
• Target: 775
• Locations: 9 countries
• Sites: 133

Brief Summary

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (International Classification of Headache Disorders, 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 Day 1 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.

Conditions

Episodic Migraine

Keywords

Migraine; Episodic Migraine; BOTOX; Botulinum Toxin Type A

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6

  The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.

  Baseline, Months 5-6

• Number of Participants With Treatment-Emergent Adverse Events (AEs)

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

  Double-Blind Phase (Week 0-24); Open-Label Phase (Week 24-48)

Secondary Outcomes (6)

• Change From Baseline in the Frequency of Monthly Headache Days Across Months 5 and 6

  Baseline, Months 5-6

• Percentage of Participants With ≥ 50% Reduction From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6

  Baseline, Months 5-6

• Change From Baseline in the Frequency of Monthly Acute Headache Medication Days Across Months 5 and 6

  Baseline, Months 5-6

• Change From Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score At Month 6

  Baseline, Month 6

• Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score Across Months 5 and 6

  Baseline, Months 5-6

Study Arms (4)

Double-Blind Phase: Placebo

PLACEBO COMPARATOR

Participants received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12.

Drug: Placebo

Double-Blind Phase: BOTOX 155 U

EXPERIMENTAL

Participants received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12.

Drug: BOTOX

Double-Blind Phase: BOTOX 195 U

EXPERIMENTAL

Participants received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12.

Drug: BOTOX

Open-Label Phase: BOTOX 195 U

EXPERIMENTAL

Eligible participants received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36.

Drug: BOTOX

Interventions

BOTOX DRUG

Intramuscular Injection

Also known as: Botulinum Toxin Type A

Double-Blind Phase: BOTOX 155 U; Double-Blind Phase: BOTOX 195 U; Open-Label Phase: BOTOX 195 U

Placebo DRUG

Intramuscular Injection

Double-Blind Phase: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of migraine headache disorder meeting International Classification of Headache Disorders (ICHD)-3 diagnostic criteria for migraine with aura or migraine without 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/baseline phase.
• Less than 15 headache days/month in each of the 3 months prior to Visit 1 and during the 4-week screening/baseline phase.

You may not qualify if:

• 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 autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache.
• History of headache attributed to another disorder (e.g., cervical dystonia, craniotomy, head/neck trauma) with exception that medication overuse headache per ICHD-3 criteria is allowed.
• History of inadequate response to \> 4 prophylactic treatment for migraine, 2 of which have different mechanisms of action.
• Female who is pregnant, breastfeeding, or considering becoming pregnant during the study or within 90 days after the last dose of study drug.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (133)

Neurology and Neurodiagnostics of Alabama /ID# 231918

Hoover, Alabama, 35244-5700, United States

Location

Rehabilitation & Neurological Services /ID# 252441

Huntsville, Alabama, 35805-4046, United States

Location

Alea Research /ID# 233329

Phoenix, Arizona, 85012-2707, United States

Location

Duplicate_Barrow Neurological Institute /ID# 231799

Phoenix, Arizona, 85013-4407, United States

Location

Clinical Endpoints /ID# 232625

Scottsdale, Arizona, 85258-4595, United States

Location

Tucson Neuroscience Research /ID# 232288

Tucson, Arizona, 85710-6152, United States

Location

Arkansas Clinical Research /ID# 231640

Little Rock, Arkansas, 72205, United States

Location

Woodland International Research Group /ID# 231492

Little Rock, Arkansas, 72211, United States

Location

Hope Clinical Research /ID# 232189

Canoga Park, California, 91303, United States

Location

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

Encino, California, 91316, United States

Location

Duplicate_Neuro Pain Medical Center /ID# 231478

Fresno, California, 93710-5473, United States

Location

Sun Valley Research Center /ID# 231350

Imperial, California, 92251-9401, United States

Location

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

Los Alamitos, California, 90720, United States

Location

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

Newport Beach, California, 92660, United States

Location

Colorado Springs Neurological Associates (CSNA) /ID# 230662

Colorado Springs, Colorado, 80907, United States

Location

Summit Headache and Neurologic Institute /ID# 231809

Englewood, Colorado, 80113-3781, United States

Location

Advanced Neurosciences Research, LLC /ID# 230658

Fort Collins, Colorado, 80528, United States

Location

Georgetown University Hospital /ID# 232129

Washington D.C., District of Columbia, 20007, United States

Location

Neurology Offices of South Florida, PLLC /ID# 232281

Boca Raton, Florida, 33428-2231, United States

Location

Nova Clinical Research, LLC /ID# 245256

Bradenton, Florida, 34209-4616, United States

Location

Velocity Clinical Research - Hallandale Beach /ID# 232442

Hallandale, Florida, 33009-4427, United States

Location

CNS Healthcare - Jacksonville /ID# 231345

Jacksonville, Florida, 32256-6039, United States

Location

Brainstorm Research /ID# 243825

Miami, Florida, 33176-2315, United States

Location

Sensible Healthcare /ID# 231340

Ocoee, Florida, 34761, United States

Location

Clinical Neuroscience Solutions, Inc /ID# 231362

Orlando, Florida, 32801-2986, United States

Location

Pain Relief Centers /ID# 232415

Sun City Center, Florida, 33573-6828, United States

Location

University of South Florida- Neuroscience Institute /ID# 231808

Tampa, Florida, 33613, United States

Location

Olympian Clinical Research - Tampa /ID# 239519

Tampa, Florida, 33615, United States

Location

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

Tampa, Florida, 33634, United States

Location

Premiere Research Institute - Palm Beach /ID# 230646

West Palm Beach, Florida, 33407-3209, United States

Location

Conquest Research /ID# 232604

Winter Park, Florida, 32789, United States

Location

Accel Research Sites Neurostudies /ID# 230665

Decatur, Georgia, 30030-2627, United States

Location

CenExcel iResearch LLC /ID# 231335

Decatur, Georgia, 30030, United States

Location

Clinical Research Institute /ID# 239517

Stockbridge, Georgia, 30281, United States

Location

Northwest Clinical Trials /ID# 230657

Boise, Idaho, 83704, United States

Location

Velocity Clinical Research - Boise /ID# 230660

Meridian, Idaho, 83642, United States

Location

Robbins Headache Clinic /ID# 230970

Riverwoods, Illinois, 60015-5711, United States

Location

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

Indianapolis, Indiana, 46256, United States

Location

Deaconess Clinic - Gateway Health Center /ID# 231329

Newburgh, Indiana, 47630, United States

Location

Duplicate_Accellacare - McFarland Clinic /ID# 231496

Ames, Iowa, 50010, United States

Location

Kansas Institute of Research /ID# 231862

Overland Park, Kansas, 66211-1363, United States

Location

Ochsner Clinic Foundation /ID# 230645

Covington, Louisiana, 70433-8107, United States

Location

Brigham and Women's Faulkner Hospital /ID# 231865

Boston, Massachusetts, 02130-3446, United States

Location

Boston Clinical Trials /ID# 231367

Boston, Massachusetts, 02131-2515, United States

Location

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

Ann Arbor, Michigan, 48104-5131, United States

Location

Minneapolis Clinic of Neurology - Burnsville /ID# 231780

Burnsville, Minnesota, 55337-6732, United States

Location

StudyMetrix Research /ID# 230642

City of Saint Peters, Missouri, 63303, United States

Location

Clinvest Research LLC /ID# 252440

Springfield, Missouri, 65807, United States

Location

Excel Clinical Research /ID# 232188

Las Vegas, Nevada, 89109, United States

Location

Las Vegas Clinical Trials /ID# 232628

North Las Vegas, Nevada, 89030-7187, United States

Location

Albuquerque Clinical Trials, Inc. /ID# 231101

Albuquerque, New Mexico, 87102, United States

Location

Duplicate_Dent Neurosciences Research Center, Inc. /ID# 252442

Amherst, New York, 14226, United States

Location

Fieve Clinical Research, Inc. /ID# 231365

New York, New York, 10017-1921, United States

Location

Montefiore Headache Center /ID# 232130

The Bronx, New York, 10461-2720, United States

Location

Upstate Clinical Research Associates /ID# 231343

Williamsville, New York, 14221-6046, United States

Location

Headache Wellness Center /ID# 230819

Greensboro, North Carolina, 27405, United States

Location

M3 Wake Research Inc. /ID# 232285

Raleigh, North Carolina, 27612-8106, United States

Location

Neurology - Triad /ID# 231733

Winston-Salem, North Carolina, 27103-6984, United States

Location

Duplicate_Duplicate_University Of Cincinnati Medical Center /ID# 231739

Cincinnati, Ohio, 45267-0585, United States

Location

IPS Research Company /ID# 231085

Oklahoma City, Oklahoma, 73106, United States

Location

Lynn Institute of Oklahoma City /ID# 231349

Oklahoma City, Oklahoma, 73112, United States

Location

Cutting Edge Research Group /ID# 231095

Oklahoma City, Oklahoma, 73116-1423, United States

Location

Sooner Clinical Research /ID# 231096

Oklahoma City, Oklahoma, 73116, United States

Location

Abington Neurological Associates - Abington /ID# 231798

Abington, Pennsylvania, 19001, United States

Location

Lehigh Center for Clinical Research /ID# 231355

Allentown, Pennsylvania, 18103, United States

Location

Suburban Research Associates - Media /ID# 231354

Media, Pennsylvania, 19063-1760, United States

Location

Jefferson Hospital for Neuroscience /ID# 230664

Philadelphia, Pennsylvania, 19107-5191, United States

Location

Duplicate_Frontier Clinical Research /ID# 232623

Smithfield, Pennsylvania, 15478, United States

Location

Clinical Trials of SC /ID# 231369

Charleston, South Carolina, 29406, United States

Location

Coastal Carolina Research Center - North Charleston /ID# 231353

North Charleston, South Carolina, 29405, United States

Location

Clinical Neuroscience Solutions - Memphis /ID# 231328

Memphis, Tennessee, 38119, United States

Location

Nashville Neuroscience Group /ID# 231642

Nashville, Tennessee, 37203, United States

Location

Austin Clinical Trial Partners /ID# 231092

Austin, Texas, 78737, United States

Location

Texas Neurology /ID# 230661

Dallas, Texas, 75214, United States

Location

NeuroCare Plus /ID# 252499

Houston, Texas, 77094-1385, United States

Location

Charlottesville Medical Research /ID# 231368

Charlottesville, Virginia, 22911, United States

Location

Integrated Neurology Services - Falls Church /ID# 244776

Falls Church, Virginia, 22043-2367, United States

Location

Tidewater Integr Med Research /ID# 231359

Virginia Beach, Virginia, 23451, United States

Location

Sentara Neurology Specialists - Virginia Beach /ID# 231341

Virginia Beach, Virginia, 23456-0019, United States

Location

Northwest Clinical Research Center /ID# 231336

Bellevue, Washington, 98007, United States

Location

Puget Sound Neurology /ID# 230640

Tacoma, Washington, 25328, United States

Location

Frontier Clinical Research - Kingwood /ID# 234127

Kingwood, West Virginia, 26537-9797, United States

Location

CHAMP Clinic /ID# 231635

Calgary, Alberta, T3M 1M4, Canada

Location

Vancouver Island Health Authority /ID# 231992

Victoria, British Columbia, V8R 1J8, Canada

Location

Maritime Neurology /ID# 232048

Halifax, Nova Scotia, B3R 1V9, Canada

Location

Toronto Memory Program /ID# 240006

Toronto, Ontario, M3B 2S7, Canada

Location

Clinique Neuro Levis /ID# 232049

Lévis, Quebec, G6W 0M5, Canada

Location

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

Brno, Brno-mesto, 656 91, Czechia

Location

Fakultni Nemocnice Ostrava /ID# 232211

Ostrava, Ostrava-mesto, 708 52, Czechia

Location

Nemocnice Jihlava, prispevkova organizace /ID# 232164

Jihlava, 586 01, Czechia

Location

Clintrial s.r.o. /ID# 232208

Prague, 100 00, Czechia

Location

DADO MEDICAL s.r.o. /ID# 232157

Prague, 120 00, Czechia

Location

Axon Clinical, s.r.o. /ID# 232212

Prague, 140 00, Czechia

Location

Fakultni Thomayerova nemocnice /ID# 232214

Prague, 140 59, Czechia

Location

Duplicate_Neurologie Klinikum Großhadern /ID# 232479

Munich, Bavaria, 81344, Germany

Location

Duplicate_Kopfschmerzzentrum Frankfurt /ID# 234066

Frankfurt am Main, Hesse, 65929, Germany

Location

Universitaetsmedizin Rostock /ID# 232471

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 239283

Dresden, Saxony, 01307, Germany

Location

Schmerzklinik Kiel /ID# 232480

Kiel, Schleswig-Holstein, 24149, Germany

Location

Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 232472

Berlin, 10117, Germany

Location

Praxis Dr. Gendolla /ID# 232474

Essen, 45133, Germany

Location

Universitaetsklinikum Essen /ID# 232478

Essen, 45147, Germany

Location

Universitaetsklinikum Halle (Saale) /ID# 241506

Halle, 06120, Germany

Location

Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 232475

Kassel, 34131, Germany

Location

Maccabi Healthcare Services /ID# 238605

Kfar Saba, Central District, 4420123, Israel

Location

Hillel Yaffe Medical Center /ID# 232122

Hadera, Haifa District, 38100, Israel

Location

Shaare Zedek Medical Center /ID# 239485

Jerusalem, Jerusalem, 91031, Israel

Location

The Chaim Sheba Medical Center /ID# 232119

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 232598

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Rambam Health Care Campus /ID# 238732

Haifa, 3109601, Israel

Location

Solumed Centrum Medyczne /ID# 238446

Poznan, Greater Poland Voivodeship, 60-529, Poland

Location

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

Krakow, Lesser Poland Voivodeship, 30-539, Poland

Location

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

Krakow, Lesser Poland Voivodeship, 30-721, Poland

Location

Instytut Zdrowia Dr Boczarska Jedynak /ID# 251857

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

Location

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

Lublin, Lublin Voivodeship, 20-582, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-119, Poland

Location

Silmedic Sp. z o.o. /ID# 232358

Katowice, Silesian Voivodeship, 40-282, Poland

Location

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

Wroclaw, 52-210, Poland

Location

Clinica Universidad de Navarra - Pamplona /ID# 232270

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Central de Asturias /ID# 232428

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Universitario Vall d'Hebron /ID# 232268

Barcelona, 08035, Spain

Location

CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 233320

Madrid, 28027, Spain

Location

Hospital Universitario La Paz /ID# 232495

Madrid, 28046, Spain

Location

Hospital Clinico Universitario de Valladolid /ID# 232272

Valladolid, 47003, Spain

Location

Skaneuro Privatmottagning /ID# 232175

Lund, Skåne County, 227 33, Sweden

Location

Neurology Clinic /ID# 234067

Stockholm, Stockholm County, 114 33, Sweden

Location

Optimuskliniken /ID# 232174

Upplands Vasby, 194 61, Sweden

Location

Linkoping University Hospital /ID# 234040

Linköping, Östergötland County, 581 85, Sweden

Location

Hull University Teaching Hospitals NHS Trust /ID# 242763

Hull, East Riding Of Yorkshire, HU3 2JZ, United Kingdom

Location

Duplicate_Queen Elizabeth University Hospital /ID# 244870

Glasgow, Glasgow City, G51 4TF, United Kingdom

Location

NHS Highland /ID# 242855

Inverness, IV2 3UJ, United Kingdom

Location

Walton Centre /ID# 242857

Liverpool, L9 7LJ, United Kingdom

Location

St Pancras Clinical Research /ID# 242764

London, EC2Y 8EA, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Migraine Disorders

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 31, 2021
• Study Start: November 5, 2021
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: December 9, 2025
• Results First Posted: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

IL (6); US (82); PL (8); CA (5); ES (6); SE (4); GB (5); CZ (7); DE (10)