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NCT05028569TerminatedPhase 3

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

Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX (Botulinum Toxin Type A) for the Prevention of Migraine in Subjects With Episodic Migraine

Source: ClinicalTrials.gov · Last updated 9 Dec 2025

Reason given: The study was terminated early due to lack of efficacy from the primary analysis results.

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
775 (actual)
First submitted
25 Aug 2021
Start date
5 Nov 2021
Primary completion date
6 Nov 2024
Lead sponsor
AbbVie
Diseases
Migraine
NCT number
NCT05028569
EudraCT number
2021-001979-16

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • 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.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (133)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
CHAMP Clinic /ID# 231635CalgaryCanadaUnknown status
Maritime Neurology /ID# 232048HalifaxCanadaUnknown status
Clinique Neuro Levis /ID# 232049LévisCanadaUnknown status
Toronto Memory Program /ID# 240006TorontoCanadaUnknown status
Vancouver Island Health Authority /ID# 231992VictoriaCanadaUnknown status
Fakultní Nemocnice U Sv. Anny V Brně /ID# 232213BrnoCzechiaUnknown status
Nemocnice Jihlava, prispevkova organizace /ID# 232164JihlavaCzechiaUnknown status
Fakultni Nemocnice Ostrava /ID# 232211OstravaCzechiaUnknown status
Fakultni Thomayerova nemocnice /ID# 232214PragueCzechiaUnknown status
DADO MEDICAL s.r.o. /ID# 232157PragueCzechiaUnknown status
Clintrial s.r.o. /ID# 232208PragueCzechiaUnknown status
Axon Clinical, s.r.o. /ID# 232212PragueCzechiaUnknown status
Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 232472BerlinGermanyUnknown status
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 239283DresdenGermanyUnknown status
Universitaetsklinikum Essen /ID# 232478EssenGermanyUnknown status
Praxis Dr. Gendolla /ID# 232474EssenGermanyUnknown status
Duplicate_Kopfschmerzzentrum Frankfurt /ID# 234066Frankfurt am MainGermanyUnknown status
Universitaetsklinikum Halle (Saale) /ID# 241506HalleGermanyUnknown status
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 232475KasselGermanyUnknown status
Schmerzklinik Kiel /ID# 232480KielGermanyUnknown status
Duplicate_Neurologie Klinikum Großhadern /ID# 232479MunichGermanyUnknown status
Universitaetsmedizin Rostock /ID# 232471RostockGermanyUnknown status
Hospital Universitario Vall d'Hebron /ID# 232268BarcelonaSpainUnknown status
Hospital Universitario La Paz /ID# 232495MadridSpainUnknown status
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 233320MadridSpainUnknown status
Hospital Universitario Central de Asturias /ID# 232428OviedoSpainUnknown status
Clinica Universidad de Navarra - Pamplona /ID# 232270PamplonaSpainUnknown status
Hospital Clinico Universitario de Valladolid /ID# 232272ValladolidSpainUnknown status
Duplicate_Queen Elizabeth University Hospital /ID# 244870GlasgowUnited KingdomUnknown status
Hull University Teaching Hospitals NHS Trust /ID# 242763HullUnited KingdomUnknown status
NHS Highland /ID# 242855InvernessUnited KingdomUnknown status
Walton Centre /ID# 242857LiverpoolUnited KingdomUnknown status
St Pancras Clinical Research /ID# 242764LondonUnited KingdomUnknown status
Hillel Yaffe Medical Center /ID# 232122HaderaIsraelUnknown status
Rambam Health Care Campus /ID# 238732HaifaIsraelUnknown status
Shaare Zedek Medical Center /ID# 239485JerusalemIsraelUnknown status
Maccabi Healthcare Services /ID# 238605Kfar SabaIsraelUnknown status
The Chaim Sheba Medical Center /ID# 232119Ramat GanIsraelUnknown status
Tel Aviv Sourasky Medical Center /ID# 232598Tel AvivIsraelUnknown status
Silmedic Sp. z o.o. /ID# 232358KatowicePolandUnknown status
Specjalistyczne Gabinety Sp. z o.o. /ID# 233526KrakowPolandUnknown status
Linden Sp. z o.o. sp.k. /ID# 245685KrakowPolandUnknown status
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 232355LublinPolandUnknown status
Instytut Zdrowia Dr Boczarska Jedynak /ID# 251857OświęcimPolandUnknown status
Solumed Centrum Medyczne /ID# 238446PoznanPolandUnknown status
Warszawska Klinika Sp. z o.o. /ID# 240612WarsawPolandUnknown status
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 241887WroclawPolandUnknown status
Linkoping University Hospital /ID# 234040LinköpingSwedenUnknown status
Skaneuro Privatmottagning /ID# 232175LundSwedenUnknown status
Neurology Clinic /ID# 234067StockholmSwedenUnknown status
Optimuskliniken /ID# 232174Upplands VasbySwedenUnknown status
Abington Neurological Associates - Abington /ID# 231798AbingtonUnited StatesUnknown status
Albuquerque Clinical Trials, Inc. /ID# 231101AlbuquerqueUnited StatesUnknown status
Lehigh Center for Clinical Research /ID# 231355AllentownUnited StatesUnknown status
Duplicate_Accellacare - McFarland Clinic /ID# 231496AmesUnited StatesUnknown status
Duplicate_Dent Neurosciences Research Center, Inc. /ID# 252442AmherstUnited StatesUnknown status
Michigan Headache & Neurological Institute (MHNI) /ID# 230659Ann ArborUnited StatesUnknown status
Austin Clinical Trial Partners /ID# 231092AustinUnited StatesUnknown status
Northwest Clinical Research Center /ID# 231336BellevueUnited StatesUnknown status
Neurology Offices of South Florida, PLLC /ID# 232281Boca RatonUnited StatesUnknown status
Northwest Clinical Trials /ID# 230657BoiseUnited StatesUnknown status
Brigham and Women's Faulkner Hospital /ID# 231865BostonUnited StatesUnknown status
Boston Clinical Trials /ID# 231367BostonUnited StatesUnknown status
Nova Clinical Research, LLC /ID# 245256BradentonUnited StatesUnknown status
Minneapolis Clinic of Neurology - Burnsville /ID# 231780BurnsvilleUnited StatesUnknown status
Hope Clinical Research /ID# 232189Canoga ParkUnited StatesUnknown status
Clinical Trials of SC /ID# 231369CharlestonUnited StatesUnknown status
Charlottesville Medical Research /ID# 231368CharlottesvilleUnited StatesUnknown status
Duplicate_Duplicate_University Of Cincinnati Medical Center /ID# 231739CincinnatiUnited StatesUnknown status
StudyMetrix Research /ID# 230642City of Saint PetersUnited StatesUnknown status
Colorado Springs Neurological Associates (CSNA) /ID# 230662Colorado SpringsUnited StatesUnknown status
Ochsner Clinic Foundation /ID# 230645CovingtonUnited StatesUnknown status
Texas Neurology /ID# 230661DallasUnited StatesUnknown status
CenExcel iResearch LLC /ID# 231335DecaturUnited StatesUnknown status
Accel Research Sites Neurostudies /ID# 230665DecaturUnited StatesUnknown status
Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351EncinoUnited StatesUnknown status
Summit Headache and Neurologic Institute /ID# 231809EnglewoodUnited StatesUnknown status
Integrated Neurology Services - Falls Church /ID# 244776Falls ChurchUnited StatesUnknown status
Advanced Neurosciences Research, LLC /ID# 230658Fort CollinsUnited StatesUnknown status
Duplicate_Neuro Pain Medical Center /ID# 231478FresnoUnited StatesUnknown status
Headache Wellness Center /ID# 230819GreensboroUnited StatesUnknown status
Velocity Clinical Research - Hallandale Beach /ID# 232442HallandaleUnited StatesUnknown status
Neurology and Neurodiagnostics of Alabama /ID# 231918HooverUnited StatesUnknown status
NeuroCare Plus /ID# 252499HoustonUnited StatesUnknown status
Rehabilitation & Neurological Services /ID# 252441HuntsvilleUnited StatesUnknown status
Sun Valley Research Center /ID# 231350ImperialUnited StatesUnknown status
Josephson-Wallack-Munshower Neurology - Northeast /ID# 230654IndianapolisUnited StatesUnknown status
CNS Healthcare - Jacksonville /ID# 231345JacksonvilleUnited StatesUnknown status
Frontier Clinical Research - Kingwood /ID# 234127KingwoodUnited StatesUnknown status
Excel Clinical Research /ID# 232188Las VegasUnited StatesUnknown status
Arkansas Clinical Research /ID# 231640Little RockUnited StatesUnknown status
Woodland International Research Group /ID# 231492Little RockUnited StatesUnknown status
Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 231908Los AlamitosUnited StatesUnknown status
Suburban Research Associates - Media /ID# 231354MediaUnited StatesUnknown status
Clinical Neuroscience Solutions - Memphis /ID# 231328MemphisUnited StatesUnknown status
Velocity Clinical Research - Boise /ID# 230660MeridianUnited StatesUnknown status
Brainstorm Research /ID# 243825MiamiUnited StatesUnknown status
Nashville Neuroscience Group /ID# 231642NashvilleUnited StatesUnknown status
Deaconess Clinic - Gateway Health Center /ID# 231329NewburghUnited StatesUnknown status
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 231337Newport BeachUnited StatesUnknown status
Fieve Clinical Research, Inc. /ID# 231365New YorkUnited StatesUnknown status
Coastal Carolina Research Center - North Charleston /ID# 231353North CharlestonUnited StatesUnknown status
Las Vegas Clinical Trials /ID# 232628North Las VegasUnited StatesUnknown status
Sensible Healthcare /ID# 231340OcoeeUnited StatesUnknown status
IPS Research Company /ID# 231085Oklahoma CityUnited StatesUnknown status
Cutting Edge Research Group /ID# 231095Oklahoma CityUnited StatesUnknown status
Sooner Clinical Research /ID# 231096Oklahoma CityUnited StatesUnknown status
Lynn Institute of Oklahoma City /ID# 231349Oklahoma CityUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc /ID# 231362OrlandoUnited StatesUnknown status
Kansas Institute of Research /ID# 231862Overland ParkUnited StatesUnknown status
Jefferson Hospital for Neuroscience /ID# 230664PhiladelphiaUnited StatesUnknown status
Alea Research /ID# 233329PhoenixUnited StatesUnknown status
Duplicate_Barrow Neurological Institute /ID# 231799PhoenixUnited StatesUnknown status
M3 Wake Research Inc. /ID# 232285RaleighUnited StatesUnknown status
Robbins Headache Clinic /ID# 230970RiverwoodsUnited StatesUnknown status
Clinical Endpoints /ID# 232625ScottsdaleUnited StatesUnknown status
Duplicate_Frontier Clinical Research /ID# 232623SmithfieldUnited StatesUnknown status
Clinvest Research LLC /ID# 252440SpringfieldUnited StatesUnknown status
Clinical Research Institute /ID# 239517StockbridgeUnited StatesUnknown status
Pain Relief Centers /ID# 232415Sun City CenterUnited StatesUnknown status
Puget Sound Neurology /ID# 230640TacomaUnited StatesUnknown status
Olympian Clinical Research - Tampa /ID# 239519TampaUnited StatesUnknown status
University of South Florida- Neuroscience Institute /ID# 231808TampaUnited StatesUnknown status
Accel Research Sites - Tampa Clinical Research Unit /ID# 231670TampaUnited StatesUnknown status
Montefiore Headache Center /ID# 232130The BronxUnited StatesUnknown status
Tucson Neuroscience Research /ID# 232288TucsonUnited StatesUnknown status
Sentara Neurology Specialists - Virginia Beach /ID# 231341Virginia BeachUnited StatesUnknown status
Tidewater Integr Med Research /ID# 231359Virginia BeachUnited StatesUnknown status
Georgetown University Hospital /ID# 232129Washington D.C.United StatesUnknown status
Premiere Research Institute - Palm Beach /ID# 230646West Palm BeachUnited StatesUnknown status
Upstate Clinical Research Associates /ID# 231343WilliamsvilleUnited StatesUnknown status
Neurology - Triad /ID# 231733Winston-SalemUnited StatesUnknown status
Conquest Research /ID# 232604Winter ParkUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.