Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
NCT ID: NCT05028569
Last Updated: 2025-12-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
775 participants
INTERVENTIONAL
2021-11-05
2024-11-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine
NCT05216263
An Observational Study of BOTOX® as Headache Prophylaxis for Chronic Migraine
NCT01686581
A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
NCT01516892
Patient Reported Outcomes in Patients With Chronic Migraine Treated With BOTOX®
NCT02502123
Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
NCT02191579
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Double-Blind Phase: Placebo
Participants received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12.
Placebo
Intramuscular Injection
Double-Blind Phase: BOTOX 155 U
Participants received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12.
BOTOX
Intramuscular Injection
Double-Blind Phase: BOTOX 195 U
Participants received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12.
BOTOX
Intramuscular Injection
Open-Label Phase: BOTOX 195 U
Eligible participants received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36.
BOTOX
Intramuscular Injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BOTOX
Intramuscular Injection
Placebo
Intramuscular Injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neurology and Neurodiagnostics of Alabama /ID# 231918
Hoover, Alabama, United States
Rehabilitation & Neurological Services /ID# 252441
Huntsville, Alabama, United States
Alea Research /ID# 233329
Phoenix, Arizona, United States
Duplicate_Barrow Neurological Institute /ID# 231799
Phoenix, Arizona, United States
Clinical Endpoints /ID# 232625
Scottsdale, Arizona, United States
Tucson Neuroscience Research /ID# 232288
Tucson, Arizona, United States
Arkansas Clinical Research /ID# 231640
Little Rock, Arkansas, United States
Woodland International Research Group /ID# 231492
Little Rock, Arkansas, United States
Hope Clinical Research /ID# 232189
Canoga Park, California, United States
Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351
Encino, California, United States
Duplicate_Neuro Pain Medical Center /ID# 231478
Fresno, California, United States
Sun Valley Research Center /ID# 231350
Imperial, California, United States
Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 231908
Los Alamitos, California, United States
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 231337
Newport Beach, California, United States
Colorado Springs Neurological Associates (CSNA) /ID# 230662
Colorado Springs, Colorado, United States
Summit Headache and Neurologic Institute /ID# 231809
Englewood, Colorado, United States
Advanced Neurosciences Research, LLC /ID# 230658
Fort Collins, Colorado, United States
Georgetown University Hospital /ID# 232129
Washington D.C., District of Columbia, United States
Neurology Offices of South Florida, PLLC /ID# 232281
Boca Raton, Florida, United States
Nova Clinical Research, LLC /ID# 245256
Bradenton, Florida, United States
Velocity Clinical Research - Hallandale Beach /ID# 232442
Hallandale, Florida, United States
CNS Healthcare - Jacksonville /ID# 231345
Jacksonville, Florida, United States
Brainstorm Research /ID# 243825
Miami, Florida, United States
Sensible Healthcare /ID# 231340
Ocoee, Florida, United States
Clinical Neuroscience Solutions, Inc /ID# 231362
Orlando, Florida, United States
Pain Relief Centers /ID# 232415
Sun City Center, Florida, United States
University of South Florida- Neuroscience Institute /ID# 231808
Tampa, Florida, United States
Olympian Clinical Research - Tampa /ID# 239519
Tampa, Florida, United States
Accel Research Sites - Tampa Clinical Research Unit /ID# 231670
Tampa, Florida, United States
Premiere Research Institute - Palm Beach /ID# 230646
West Palm Beach, Florida, United States
Conquest Research /ID# 232604
Winter Park, Florida, United States
Accel Research Sites Neurostudies /ID# 230665
Decatur, Georgia, United States
CenExcel iResearch LLC /ID# 231335
Decatur, Georgia, United States
Clinical Research Institute /ID# 239517
Stockbridge, Georgia, United States
Northwest Clinical Trials /ID# 230657
Boise, Idaho, United States
Velocity Clinical Research - Boise /ID# 230660
Meridian, Idaho, United States
Robbins Headache Clinic /ID# 230970
Riverwoods, Illinois, United States
Josephson-Wallack-Munshower Neurology - Northeast /ID# 230654
Indianapolis, Indiana, United States
Deaconess Clinic - Gateway Health Center /ID# 231329
Newburgh, Indiana, United States
Duplicate_Accellacare - McFarland Clinic /ID# 231496
Ames, Iowa, United States
Kansas Institute of Research /ID# 231862
Overland Park, Kansas, United States
Ochsner Clinic Foundation /ID# 230645
Covington, Louisiana, United States
Brigham and Women's Faulkner Hospital /ID# 231865
Boston, Massachusetts, United States
Boston Clinical Trials /ID# 231367
Boston, Massachusetts, United States
Michigan Headache & Neurological Institute (MHNI) /ID# 230659
Ann Arbor, Michigan, United States
Minneapolis Clinic of Neurology - Burnsville /ID# 231780
Burnsville, Minnesota, United States
StudyMetrix Research /ID# 230642
City of Saint Peters, Missouri, United States
Clinvest Research LLC /ID# 252440
Springfield, Missouri, United States
Excel Clinical Research /ID# 232188
Las Vegas, Nevada, United States
Las Vegas Clinical Trials /ID# 232628
North Las Vegas, Nevada, United States
Albuquerque Clinical Trials, Inc. /ID# 231101
Albuquerque, New Mexico, United States
Duplicate_Dent Neurosciences Research Center, Inc. /ID# 252442
Amherst, New York, United States
Fieve Clinical Research, Inc. /ID# 231365
New York, New York, United States
Montefiore Headache Center /ID# 232130
The Bronx, New York, United States
Upstate Clinical Research Associates /ID# 231343
Williamsville, New York, United States
Headache Wellness Center /ID# 230819
Greensboro, North Carolina, United States
M3 Wake Research Inc. /ID# 232285
Raleigh, North Carolina, United States
Neurology - Triad /ID# 231733
Winston-Salem, North Carolina, United States
Duplicate_Duplicate_University Of Cincinnati Medical Center /ID# 231739
Cincinnati, Ohio, United States
IPS Research Company /ID# 231085
Oklahoma City, Oklahoma, United States
Lynn Institute of Oklahoma City /ID# 231349
Oklahoma City, Oklahoma, United States
Cutting Edge Research Group /ID# 231095
Oklahoma City, Oklahoma, United States
Sooner Clinical Research /ID# 231096
Oklahoma City, Oklahoma, United States
Abington Neurological Associates - Abington /ID# 231798
Abington, Pennsylvania, United States
Lehigh Center for Clinical Research /ID# 231355
Allentown, Pennsylvania, United States
Suburban Research Associates - Media /ID# 231354
Media, Pennsylvania, United States
Jefferson Hospital for Neuroscience /ID# 230664
Philadelphia, Pennsylvania, United States
Duplicate_Frontier Clinical Research /ID# 232623
Smithfield, Pennsylvania, United States
Clinical Trials of SC /ID# 231369
Charleston, South Carolina, United States
Coastal Carolina Research Center - North Charleston /ID# 231353
North Charleston, South Carolina, United States
Clinical Neuroscience Solutions - Memphis /ID# 231328
Memphis, Tennessee, United States
Nashville Neuroscience Group /ID# 231642
Nashville, Tennessee, United States
Austin Clinical Trial Partners /ID# 231092
Austin, Texas, United States
Texas Neurology /ID# 230661
Dallas, Texas, United States
NeuroCare Plus /ID# 252499
Houston, Texas, United States
Charlottesville Medical Research /ID# 231368
Charlottesville, Virginia, United States
Integrated Neurology Services - Falls Church /ID# 244776
Falls Church, Virginia, United States
Tidewater Integr Med Research /ID# 231359
Virginia Beach, Virginia, United States
Sentara Neurology Specialists - Virginia Beach /ID# 231341
Virginia Beach, Virginia, United States
Northwest Clinical Research Center /ID# 231336
Bellevue, Washington, United States
Puget Sound Neurology /ID# 230640
Tacoma, Washington, United States
Frontier Clinical Research - Kingwood /ID# 234127
Kingwood, West Virginia, United States
CHAMP Clinic /ID# 231635
Calgary, Alberta, Canada
Vancouver Island Health Authority /ID# 231992
Victoria, British Columbia, Canada
Maritime Neurology /ID# 232048
Halifax, Nova Scotia, Canada
Toronto Memory Program /ID# 240006
Toronto, Ontario, Canada
Clinique Neuro Levis /ID# 232049
Lévis, Quebec, Canada
Fakultní Nemocnice U Sv. Anny V Brně /ID# 232213
Brno, Brno-mesto, Czechia
Fakultni Nemocnice Ostrava /ID# 232211
Ostrava, Ostrava-mesto, Czechia
Nemocnice Jihlava, prispevkova organizace /ID# 232164
Jihlava, , Czechia
Clintrial s.r.o. /ID# 232208
Prague, , Czechia
DADO MEDICAL s.r.o. /ID# 232157
Prague, , Czechia
Axon Clinical, s.r.o. /ID# 232212
Prague, , Czechia
Fakultni Thomayerova nemocnice /ID# 232214
Prague, , Czechia
Duplicate_Neurologie Klinikum Großhadern /ID# 232479
Munich, Bavaria, Germany
Duplicate_Kopfschmerzzentrum Frankfurt /ID# 234066
Frankfurt am Main, Hesse, Germany
Universitaetsmedizin Rostock /ID# 232471
Rostock, Mecklenburg-Vorpommern, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 239283
Dresden, Saxony, Germany
Schmerzklinik Kiel /ID# 232480
Kiel, Schleswig-Holstein, Germany
Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 232472
Berlin, , Germany
Praxis Dr. Gendolla /ID# 232474
Essen, , Germany
Universitaetsklinikum Essen /ID# 232478
Essen, , Germany
Universitaetsklinikum Halle (Saale) /ID# 241506
Halle, , Germany
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 232475
Kassel, , Germany
Maccabi Healthcare Services /ID# 238605
Kfar Saba, Central District, Israel
Hillel Yaffe Medical Center /ID# 232122
Hadera, Haifa District, Israel
Shaare Zedek Medical Center /ID# 239485
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 232119
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 232598
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 238732
Haifa, , Israel
Solumed Centrum Medyczne /ID# 238446
Poznan, Greater Poland Voivodeship, Poland
Specjalistyczne Gabinety Sp. z o.o. /ID# 233526
Krakow, Lesser Poland Voivodeship, Poland
Linden Sp. z o.o. sp.k. /ID# 245685
Krakow, Lesser Poland Voivodeship, Poland
Instytut Zdrowia Dr Boczarska Jedynak /ID# 251857
Oświęcim, Lesser Poland Voivodeship, Poland
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 232355
Lublin, Lublin Voivodeship, Poland
Warszawska Klinika Sp. z o.o. /ID# 240612
Warsaw, Masovian Voivodeship, Poland
Silmedic Sp. z o.o. /ID# 232358
Katowice, Silesian Voivodeship, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 241887
Wroclaw, , Poland
Clinica Universidad de Navarra - Pamplona /ID# 232270
Pamplona, Navarre, Spain
Hospital Universitario Central de Asturias /ID# 232428
Oviedo, Principality of Asturias, Spain
Hospital Universitario Vall d'Hebron /ID# 232268
Barcelona, , Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 233320
Madrid, , Spain
Hospital Universitario La Paz /ID# 232495
Madrid, , Spain
Hospital Clinico Universitario de Valladolid /ID# 232272
Valladolid, , Spain
Skaneuro Privatmottagning /ID# 232175
Lund, Skåne County, Sweden
Neurology Clinic /ID# 234067
Stockholm, Stockholm County, Sweden
Optimuskliniken /ID# 232174
Upplands Vasby, , Sweden
Linkoping University Hospital /ID# 234040
Linköping, Östergötland County, Sweden
Hull University Teaching Hospitals NHS Trust /ID# 242763
Hull, East Riding Of Yorkshire, United Kingdom
Duplicate_Queen Elizabeth University Hospital /ID# 244870
Glasgow, Glasgow City, United Kingdom
NHS Highland /ID# 242855
Inverness, , United Kingdom
Walton Centre /ID# 242857
Liverpool, , United Kingdom
St Pancras Clinical Research /ID# 242764
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-001979-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M21-307
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.