Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
- Registration Number
- NCT05028569
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 775
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double-Blind, Placebo-Controlled Phase: Placebo Placebo Participants will receive placebo on Week 0 and Week 12. Double-Blind, Placebo-Controlled Phase: BOTOX Dose A BOTOX Participants will receive BOTOX Dose A on Week 0 and Week 12. Double-Blind, Placebo-Controlled Phase: Placebo BOTOX Participants will receive placebo on Week 0 and Week 12. Double-Blind, Placebo-Controlled Phase: BOTOX Dose B BOTOX Participants will receive BOTOX Dose B on Week 0 and Week 12. Open-Label Phase: BOTOX Dose A BOTOX Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Frequency of Monthly Migraine Days 6 Months Change from baseline in the frequency of monthly migraine days (i.e., migraine or probable migraine headache days) will be assessed.
Number of Participants with Treatment Emergent Adverse Events (AEs) Up to approximately 52 weeks An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score 6 Months Role Function Restrictive (RFR) domain assesses how migraines limit one's daily social and work-related activities using a 6-point scale ranging from "none of the time" to "all of the time".
Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score 6 Months AIM-D Physical impairment Domain Score asks participants to rate the level of difficulty experienced with physical impairment using a 6-point rating scale ranging from "not difficult at all" to "I could not do it at all".
Change From Baseline in the Frequency of Monthly Headache Days 6 Months Change from baseline in the frequency of monthly headache days will be assessed.
Responder Status of 50% Reduction From Baseline in the Frequency of Monthly Migraine Days 6 Months Percentage of participants achieving 50% reduction from baseline in the frequency of monthly migraine days will be assessed.
Change From Baseline in the Frequency of Monthly Acute Headache Medication Days 6 Months The change from baseline in acute migraine medication use days will be assessed.
Trial Locations
- Locations (133)
Albuquerque Clinical Trials, Inc. /ID# 231101
๐บ๐ธAlbuquerque, New Mexico, United States
Duplicate_University Of Cincinnati Medical Center /ID# 231739
๐บ๐ธCincinnati, Ohio, United States
Fakultnรญ Nemocnice U Sv. Anny V Brnฤ /ID# 232213
๐จ๐ฟBrno, Brno-mesto, Czechia
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 239283
๐ฉ๐ชDresden, Sachsen, Germany
Neurology and Neurodiagnostics of Alabama /ID# 231918
๐บ๐ธHoover, Alabama, United States
Rehabilitation & Neurological Services /ID# 252441
๐บ๐ธHuntsville, Alabama, United States
Alea Research /ID# 233329
๐บ๐ธPhoenix, Arizona, United States
Duplicate_Barrow Neurological Institute /ID# 231799
๐บ๐ธPhoenix, Arizona, United States
Clinical Endpoints /ID# 232625
๐บ๐ธScottsdale, Arizona, United States
Tucson Neuroscience Research /ID# 232288
๐บ๐ธTucson, Arizona, United States
Arkansas Clinical Research /ID# 231640
๐บ๐ธLittle Rock, Arkansas, United States
Woodland International Research Group /ID# 231492
๐บ๐ธLittle Rock, Arkansas, United States
Hope Clinical Research /ID# 232189
๐บ๐ธCanoga Park, California, United States
Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351
๐บ๐ธEncino, California, United States
Neuro Pain Medical Center /ID# 231478
๐บ๐ธFresno, California, United States
Sun Valley Research Center /ID# 231350
๐บ๐ธImperial, California, United States
Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 231908
๐บ๐ธLos Alamitos, California, United States
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 231337
๐บ๐ธNewport Beach, California, United States
Colorado Springs Neurological Associates (CSNA) /ID# 230662
๐บ๐ธColorado Springs, Colorado, United States
Summit Headache and Neurologic Institute /ID# 231809
๐บ๐ธEnglewood, Colorado, United States
Advanced Neurosciences Research, LLC /ID# 230658
๐บ๐ธFort Collins, Colorado, United States
Georgetown University Hospital /ID# 232129
๐บ๐ธWashington, District of Columbia, United States
Neurology Offices of South Florida, PLLC /ID# 232281
๐บ๐ธBoca Raton, Florida, United States
Nova Clinical Research, LLC /ID# 245256
๐บ๐ธBradenton, Florida, United States
Velocity Clinical Research - Hallandale Beach /ID# 232442
๐บ๐ธHallandale Beach, Florida, United States
CNS Healthcare - Jacksonville /ID# 231345
๐บ๐ธJacksonville, Florida, United States
Brainstorm Research /ID# 243825
๐บ๐ธMiami, Florida, United States
Sensible Healthcare /ID# 231340
๐บ๐ธOcoee, Florida, United States
Clinical Neuroscience Solutions, Inc /ID# 231362
๐บ๐ธOrlando, Florida, United States
Pain Relief Centers /ID# 232415
๐บ๐ธSun City Center, Florida, United States
University of South Florida- Neuroscience Institute /ID# 231808
๐บ๐ธTampa, Florida, United States
Olympian Clinical Research - Tampa /ID# 239519
๐บ๐ธTampa, Florida, United States
Accel Research Sites - Tampa Clinical Research Unit /ID# 231670
๐บ๐ธTampa, Florida, United States
Premiere Research Institute - Palm Beach /ID# 230646
๐บ๐ธWest Palm Beach, Florida, United States
Conquest Research /ID# 232604
๐บ๐ธWinter Park, Florida, United States
Accel Research Sites Neurostudies /ID# 230665
๐บ๐ธDecatur, Georgia, United States
CenExcel iResearch LLC /ID# 231335
๐บ๐ธDecatur, Georgia, United States
Clinical Research Institute /ID# 239517
๐บ๐ธStockbridge, Georgia, United States
Northwest Clinical Trials /ID# 230657
๐บ๐ธBoise, Idaho, United States
Velocity Clinical Research - Boise /ID# 230660
๐บ๐ธMeridian, Idaho, United States
Robbins Headache Clinic /ID# 230970
๐บ๐ธRiverwoods, Illinois, United States
Josephson-Wallack-Munshower Neurology - Northeast /ID# 230654
๐บ๐ธIndianapolis, Indiana, United States
Deaconess Clinic - Gateway Health Center /ID# 231329
๐บ๐ธNewburgh, Indiana, United States
Accellacare /ID# 231496
๐บ๐ธAmes, Iowa, United States
Kansas Institute of Research /ID# 231862
๐บ๐ธOverland Park, Kansas, United States
Ochsner Clinic Foundation /ID# 230645
๐บ๐ธCovington, Louisiana, United States
Brigham and Women's Faulkner Hospital /ID# 231865
๐บ๐ธBoston, Massachusetts, United States
Boston Clinical Trials /ID# 231367
๐บ๐ธBoston, Massachusetts, United States
Michigan Headache & Neurological Institute (MHNI) /ID# 230659
๐บ๐ธAnn Arbor, Michigan, United States
Minneapolis Clinic of Neurology - Burnsville /ID# 231780
๐บ๐ธBurnsville, Minnesota, United States
StudyMetrix Research /ID# 230642
๐บ๐ธSaint Peters, Missouri, United States
Clinvest Research LLC /ID# 252440
๐บ๐ธSpringfield, Missouri, United States
Excel Clinical Research /ID# 232188
๐บ๐ธLas Vegas, Nevada, United States
Las Vegas Clinical Trials /ID# 232628
๐บ๐ธNorth Las Vegas, Nevada, United States
Dent Neurosciences Research Center, Inc. /ID# 252442
๐บ๐ธAmherst, New York, United States
Montefiore Headache Center /ID# 232130
๐บ๐ธBronx, New York, United States
Fieve Clinical Research, Inc. /ID# 231365
๐บ๐ธNew York, New York, United States
Upstate Clinical Research Associates /ID# 231343
๐บ๐ธWilliamsville, New York, United States
Headache Wellness Center /ID# 230819
๐บ๐ธGreensboro, North Carolina, United States
M3 Wake Research Inc. /ID# 232285
๐บ๐ธRaleigh, North Carolina, United States
Neurology - Triad /ID# 231733
๐บ๐ธWinston-Salem, North Carolina, United States
IPS Research Company /ID# 231085
๐บ๐ธOklahoma City, Oklahoma, United States
Lynn Institute of Oklahoma City /ID# 231349
๐บ๐ธOklahoma City, Oklahoma, United States
Cutting Edge Research Group /ID# 231095
๐บ๐ธOklahoma City, Oklahoma, United States
Sooner Clinical Research /ID# 231096
๐บ๐ธOklahoma City, Oklahoma, United States
Abington Neurological Associates - Abington /ID# 231798
๐บ๐ธAbington, Pennsylvania, United States
Lehigh Center for Clinical Research /ID# 231355
๐บ๐ธAllentown, Pennsylvania, United States
Suburban Research Associates - Media /ID# 231354
๐บ๐ธMedia, Pennsylvania, United States
Jefferson Hospital for Neuroscience /ID# 230664
๐บ๐ธPhiladelphia, Pennsylvania, United States
Frontier Clinical Research /ID# 232623
๐บ๐ธSmithfield, Pennsylvania, United States
Clinical Trials of SC /ID# 231369
๐บ๐ธCharleston, South Carolina, United States
Coastal Carolina Research Center - North Charleston /ID# 231353
๐บ๐ธNorth Charleston, South Carolina, United States
Clinical Neuroscience Solutions - Memphis /ID# 231328
๐บ๐ธMemphis, Tennessee, United States
Nashville Neuroscience Group /ID# 231642
๐บ๐ธNashville, Tennessee, United States
Austin Clinical Trial Partners /ID# 231092
๐บ๐ธAustin, Texas, United States
Texas Neurology /ID# 230661
๐บ๐ธDallas, Texas, United States
NeuroCare Plus /ID# 252499
๐บ๐ธHouston, Texas, United States
Charlottesville Medical Research /ID# 231368
๐บ๐ธCharlottesville, Virginia, United States
Integrated Neurology Services - Falls Church /ID# 244776
๐บ๐ธFalls Church, Virginia, United States
Tidewater Integr Med Research /ID# 231359
๐บ๐ธVirginia Beach, Virginia, United States
Sentara Neurology Specialists - Virginia Beach /ID# 231341
๐บ๐ธVirginia Beach, Virginia, United States
Northwest Clinical Research Center /ID# 231336
๐บ๐ธBellevue, Washington, United States
Puget Sound Neurology /ID# 230640
๐บ๐ธTacoma, Washington, United States
Frontier Clinical Research - Kingwood /ID# 234127
๐บ๐ธKingwood, West Virginia, United States
CHAMP Clinic /ID# 231635
๐จ๐ฆCalgary, Alberta, Canada
Vancouver Island Health Authority /ID# 231992
๐จ๐ฆVictoria, British Columbia, Canada
Maritime Neurology /ID# 232048
๐จ๐ฆHalifax, Nova Scotia, Canada
Toronto Memory Program /ID# 240006
๐จ๐ฆToronto, Ontario, Canada
Clinique Neuro Levis /ID# 232049
๐จ๐ฆLรฉvis, Quebec, Canada
Fakultni Nemocnice Ostrava /ID# 232211
๐จ๐ฟOstrava, Ostrava-mesto, Czechia
Nemocnice Jihlava, prispevkova organizace /ID# 232164
๐จ๐ฟJihlava, Czechia
Clintrial s.r.o. /ID# 232208
๐จ๐ฟPrague 10, Czechia
DADO MEDICAL s.r.o. /ID# 232157
๐จ๐ฟPraha, Czechia
Axon Clinical, s.r.o. /ID# 232212
๐จ๐ฟPraha, Czechia
Fakultni Thomayerova nemocnice /ID# 232214
๐จ๐ฟPraha, Czechia
Universitaetsmedizin Rostock /ID# 232471
๐ฉ๐ชRostock, Mecklenburg-Vorpommern, Germany
Schmerzklinik Kiel /ID# 232480
๐ฉ๐ชKiel, Schleswig-Holstein, Germany
Zentrum fรผr Neurologie, Neurochirurgie und Psychiatrie /ID# 232472
๐ฉ๐ชBerlin, Germany
Praxis Dr. Gendolla /ID# 232474
๐ฉ๐ชEssen, Germany
Universitaetsklinikum Essen /ID# 232478
๐ฉ๐ชEssen, Germany
Kopfschmerzzentrum Frankfurt /ID# 234066
๐ฉ๐ชFrankfurt am Main, Germany
Universitaetsklinikum Halle (Saale) /ID# 241506
๐ฉ๐ชHalle (Saale), Germany
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 232475
๐ฉ๐ชKassel, Germany
Neurologie Klinikum Groรhadern /ID# 232479
๐ฉ๐ชMunich, Germany
Hillel Yaffe Medical Center /ID# 232122
๐ฎ๐ฑHadera, H_efa, Israel
Rambam Health Care Campus /ID# 238732
๐ฎ๐ฑHaifa, H_efa, Israel
Maccabi Healthcare Services /ID# 238605
๐ฎ๐ฑKfar Saba, HaMerkaz, Israel
The Chaim Sheba Medical Center /ID# 232119
๐ฎ๐ฑRamat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 232598
๐ฎ๐ฑTel Aviv, Tel-Aviv, Israel
Shaare Zedek Medical Center /ID# 239485
๐ฎ๐ฑJerusalem, Yerushalayim, Israel
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 232355
๐ต๐ฑLublin, Lubelskie, Poland
Specjalistyczne Gabinety Sp. z o.o. /ID# 233526
๐ต๐ฑKrakow, Malopolskie, Poland
Linden Sp. z o.o. sp.k. /ID# 245685
๐ต๐ฑKrakow, Malopolskie, Poland
Instytut Zdrowia Dr Boczarska Jedynak /ID# 251857
๐ต๐ฑOลwiฤcim, Malopolskie, Poland
Warszawska Klinika Sp. z o.o. /ID# 240612
๐ต๐ฑWarszawa, Mazowieckie, Poland
Silmedic Sp. z o.o. /ID# 232358
๐ต๐ฑKatowice, Slaskie, Poland
Solumed Centrum Medyczne /ID# 238446
๐ต๐ฑPoznan, Wielkopolskie, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 241887
๐ต๐ฑWroclaw, Poland
Hospital Universitario Central de Asturias /ID# 232428
๐ช๐ธOviedo, Asturias, Spain
Clinica Universidad de Navarra - Pamplona /ID# 232270
๐ช๐ธPamplona, Navarra, Spain
Hospital Universitario Vall d'Hebron /ID# 232268
๐ช๐ธBarcelona, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 233320
๐ช๐ธMadrid, Spain
Hospital Universitario La Paz /ID# 232495
๐ช๐ธMadrid, Spain
Hospital Clinico Universitario de Valladolid /ID# 232272
๐ช๐ธValladolid, Spain
Linkoping University Hospital /ID# 234040
๐ธ๐ชLinkoping, Ostergotlands Lan, Sweden
Skaneuro Privatmottagning /ID# 232175
๐ธ๐ชLund, Skane Lan, Sweden
Neurology Clinic /ID# 234067
๐ธ๐ชStockholm, Stockholms Lan, Sweden
Optimuskliniken /ID# 232174
๐ธ๐ชUpplands Vasby, Sweden
Hull University Teaching Hospitals NHS Trust /ID# 242763
๐ฌ๐งHull, East Riding Of Yorkshire, United Kingdom
Queen Elizabeth University Hospital /ID# 244870
๐ฌ๐งGlasgow, United Kingdom
NHS Highland /ID# 242855
๐ฌ๐งInverness, United Kingdom
Walton Centre /ID# 242857
๐ฌ๐งLiverpool, United Kingdom
St Pancras Clinical Research /ID# 242764
๐ฌ๐งLondon, United Kingdom