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

ClinicalTrials.gov processed this data on June 5, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified June 2024 by AbbVie

Sponsor

AbbVie

Information Provided by (Responsible Party)

AbbVie

Clinicaltrials.gov Identifier

NCT05028569
Other Study ID Numbers: M21-307
First Submitted: August 25, 2021
First Posted: August 31, 2021
Last Update Posted: June 6, 2024
Last Verified: June 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Episodic Migraine
  • Drug: BOTOX
  • Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment775 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposePrevention
Official TitlePhase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX (Botulinum Toxin Type A) for the Prevention of Migraine in Subjects With Episodic Migraine
Study Start DateNovember 5, 2021
Anticipated Primary Completion DateNovember 25, 2024
Anticipated Study Completion DateNovember 25, 2024

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Double-Blind, Placebo-Controlled Phase: BOTOX Dose A
    • Participants will receive BOTOX Dose A on Week 0 and Week 12.
  • Drug: BOTOX
    • Intramuscular Injection
  • Double-Blind, Placebo-Controlled Phase: BOTOX Dose B
    • Participants will receive BOTOX Dose B on Week 0 and Week 12.
  • Drug: BOTOX
    • Intramuscular Injection
  • Double-Blind, Placebo-Controlled Phase: Placebo
    • Participants will receive placebo on Week 0 and Week 12.
  • Drug: BOTOX
    • Intramuscular Injection
  • Drug: Placebo
    • Open-Label Phase: BOTOX Dose A
      • Eligible participants will receive BOTOX Dose A on Week 24 and Week 36.
    • Drug: BOTOX
      • Intramuscular Injection

    Outcome Measures

    Primary Outcome Measures

    1. 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.
    2. 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

    1. 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.
    2. 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.
    3. 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.
    4. 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".
    5. 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".

    Eligibility Criteria

    Ages Eligible for Study 18 Years to 65 Years (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    Inclusion Criteria
    • 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.
    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 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.

    Contacts and Locations

    Sponsors and Collaborators AbbVie
    Locations
    • Neurology and Neurodiagnostics of Alabama /ID# 231918 | Hoover, Alabama, United States, 35244-5700
    • Rehabilitation & Neurological Services /ID# 252441 | Huntsville, Alabama, United States, 35805-4046
    • Alea Research /ID# 233329 | Phoenix, Arizona, United States, 85012-2707
    • Duplicate_Barrow Neurological Institute /ID# 231799 | Phoenix, Arizona, United States, 85013-4407
    • Clinical Endpoints /ID# 232625 | Scottsdale, Arizona, United States, 85258-4595
    • Tucson Neuroscience Research /ID# 232288 | Tucson, Arizona, United States, 85710-6152
    • Arkansas Clinical Research /ID# 231640 | Little Rock, Arkansas, United States, 72205
    • Woodland International Research Group /ID# 231492 | Little Rock, Arkansas, United States, 72211
    • Hope Clinical Research /ID# 232189 | Canoga Park, California, United States, 91303
    • Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351 | Encino, California, United States, 91316
    • Neuro Pain Medical Center /ID# 231478 | Fresno, California, United States, 93710-5473
    • Sun Valley Research Center /ID# 231350 | Imperial, California, United States, 92251-9401
    • Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 231908 | Los Alamitos, California, United States, 90720
    • Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 231337 | Newport Beach, California, United States, 92660
    • Colorado Springs Neurological Associates (CSNA) /ID# 230662 | Colorado Springs, Colorado, United States, 80907
    • Summit Headache and Neurologic Institute /ID# 231809 | Englewood, Colorado, United States, 80113-3781
    • Advanced Neurosciences Research, LLC /ID# 230658 | Fort Collins, Colorado, United States, 80528
    • Georgetown University Hospital /ID# 232129 | Washington, District of Columbia, United States, 20007
    • Neurology Offices of South Florida, PLLC /ID# 232281 | Boca Raton, Florida, United States, 33428-2231
    • Nova Clinical Research, LLC /ID# 245256 | Bradenton, Florida, United States, 34209-4616
    • Velocity Clinical Research - Hallandale Beach /ID# 232442 | Hallandale Beach, Florida, United States, 33009-4427
    • CNS Healthcare - Jacksonville /ID# 231345 | Jacksonville, Florida, United States, 32256-6039
    • Brainstorm Research /ID# 243825 | Miami, Florida, United States, 33176-2315
    • Sensible Healthcare /ID# 231340 | Ocoee, Florida, United States, 34761
    • Clinical Neuroscience Solutions, Inc /ID# 231362 | Orlando, Florida, United States, 32801-2986
    • Pain Relief Centers /ID# 232415 | Sun City Center, Florida, United States, 33573-6828
    • University of South Florida- Neuroscience Institute /ID# 231808 | Tampa, Florida, United States, 33613
    • Olympian Clinical Research - Tampa /ID# 239519 | Tampa, Florida, United States, 33615
    • Accel Research Sites - Tampa Clinical Research Unit /ID# 231670 | Tampa, Florida, United States, 33634
    • Premiere Research Institute - Palm Beach /ID# 230646 | West Palm Beach, Florida, United States, 33407-3209
    • Conquest Research /ID# 232604 | Winter Park, Florida, United States, 32789
    • Accel Research Sites Neurostudies /ID# 230665 | Decatur, Georgia, United States, 30030-2627
    • CenExcel iResearch LLC /ID# 231335 | Decatur, Georgia, United States, 30030
    • Clinical Research Institute /ID# 239517 | Stockbridge, Georgia, United States, 30281
    • Northwest Clinical Trials /ID# 230657 | Boise, Idaho, United States, 83704
    • Velocity Clinical Research - Boise /ID# 230660 | Meridian, Idaho, United States, 83642
    • Robbins Headache Clinic /ID# 230970 | Riverwoods, Illinois, United States, 60015-5711
    • Josephson-Wallack-Munshower Neurology - Northeast /ID# 230654 | Indianapolis, Indiana, United States, 46256
    • Deaconess Clinic - Gateway Health Center /ID# 231329 | Newburgh, Indiana, United States, 47630
    • Accellacare /ID# 231496 | Ames, Iowa, United States, 50010
    • Kansas Institute of Research /ID# 231862 | Overland Park, Kansas, United States, 66211-1363
    • Ochsner Clinic Foundation /ID# 230645 | Covington, Louisiana, United States, 70433-8107
    • Brigham and Women's Faulkner Hospital /ID# 231865 | Boston, Massachusetts, United States, 02130-3446
    • Boston Clinical Trials /ID# 231367 | Boston, Massachusetts, United States, 02131-2515
    • Michigan Headache & Neurological Institute (MHNI) /ID# 230659 | Ann Arbor, Michigan, United States, 48104-5131
    • Minneapolis Clinic of Neurology - Burnsville /ID# 231780 | Burnsville, Minnesota, United States, 55337-6732
    • StudyMetrix Research /ID# 230642 | Saint Peters, Missouri, United States, 63303
    • Clinvest Research LLC /ID# 252440 | Springfield, Missouri, United States, 65807
    • Excel Clinical Research /ID# 232188 | Las Vegas, Nevada, United States, 89109
    • Las Vegas Clinical Trials /ID# 232628 | North Las Vegas, Nevada, United States, 89030-7187
    • Albuquerque Clinical Trials, Inc /ID# 231101 | Albuquerque, New Mexico, United States, 87102
    • Dent Neurosciences Research Center, Inc. /ID# 252442 | Amherst, New York, United States, 14226
    • Montefiore Headache Center /ID# 232130 | Bronx, New York, United States, 10461-2720
    • Fieve Clinical Research, Inc. /ID# 231365 | New York, New York, United States, 10017-1921
    • Upstate Clinical Research Associates /ID# 231343 | Williamsville, New York, United States, 14221-6046
    • Headache Wellness Center /ID# 230819 | Greensboro, North Carolina, United States, 27405
    • M3 Wake Research Inc. /ID# 232285 | Raleigh, North Carolina, United States, 27612-8106
    • Neurology - Triad /ID# 231733 | Winston-Salem, North Carolina, United States, 27103-6984
    • University of Cincinnati /ID# 231739 | Cincinnati, Ohio, United States, 45267-0585
    • IPS Research Company /ID# 231085 | Oklahoma City, Oklahoma, United States, 73106
    • Lynn Institute of Oklahoma City /ID# 231349 | Oklahoma City, Oklahoma, United States, 73112
    • Sooner Clinical Research /ID# 231096 | Oklahoma City, Oklahoma, United States, 73112
    • Cutting Edge Research Group /ID# 231095 | Oklahoma City, Oklahoma, United States, 73116-1423
    • Abington Neurological Associates - Abington /ID# 231798 | Abington, Pennsylvania, United States, 19001
    • Lehigh Center for Clinical Research /ID# 231355 | Allentown, Pennsylvania, United States, 18104
    • Suburban Research Associates - Media /ID# 231354 | Media, Pennsylvania, United States, 19063-1760
    • Jefferson Hospital for Neuroscience /ID# 230664 | Philadelphia, Pennsylvania, United States, 19107-5191
    • Frontier Clinical Research /ID# 232623 | Smithfield, Pennsylvania, United States, 15478
    • Clinical Trials of SC /ID# 231369 | Charleston, South Carolina, United States, 29406
    • Coastal Carolina Research Center - North Charleston /ID# 231353 | North Charleston, South Carolina, United States, 29405
    • Clinical Neuroscience Solutions - Memphis /ID# 231328 | Memphis, Tennessee, United States, 38119
    • Nashville Neuroscience Group /ID# 231642 | Nashville, Tennessee, United States, 37203
    • Austin Clinical Trial Partners /ID# 231092 | Austin, Texas, United States, 78737
    • Texas Neurology /ID# 230661 | Dallas, Texas, United States, 75214
    • NeuroCare Plus /ID# 252499 | Houston, Texas, United States, 77094-1385
    • Charlottesville Medical Research /ID# 231368 | Charlottesville, Virginia, United States, 22911
    • Integrated Neurology Services - Falls Church /ID# 244776 | Falls Church, Virginia, United States, 22043-2367
    • Tidewater Integr Med Research /ID# 231359 | Virginia Beach, Virginia, United States, 23451
    • Sentara Neurology Specialists - Virginia Beach /ID# 231341 | Virginia Beach, Virginia, United States, 23456-0019
    • Northwest Clinical Research Center /ID# 231336 | Bellevue, Washington, United States, 98007
    • Puget Sound Neurology /ID# 230640 | Tacoma, Washington, United States, 25328
    • Frontier Clinical Research - Kingwood /ID# 234127 | Kingwood, West Virginia, United States, 26537-9797
    • CHAMP Clinic /ID# 231635 | Calgary, Alberta, Canada, T3M 1M4
    • Vancouver Island Health Authority /ID# 231992 | Victoria, British Columbia, Canada, V8R 1J8
    • Maritime Neurology /ID# 232048 | Halifax, Nova Scotia, Canada, B3R 1V9
    • Toronto Memory Program /ID# 240006 | Toronto, Ontario, Canada, M3B 2S7
    • Clinique Neuro Levis /ID# 232049 | Lévis, Quebec, Canada, G6W 0M5
    • Fakultni nemocnice u sv. Anny v Brne /ID# 232213 | Brno, Czechia, 656 91
    • Nemocnice Jihlava, prispevkova organizace /ID# 232164 | Jihlava, Czechia, 586 01
    • Fakultni Nemocnice Ostrava /ID# 232211 | Ostrava, Czechia, 708 52
    • Clintrial s.r.o. /ID# 232208 | Prague 10, Czechia, 100 00
    • DADO MEDICAL s.r.o. /ID# 232157 | Praha, Czechia, 120 00
    • Axon Clinical, s.r.o. /ID# 232212 | Praha, Czechia, 140 00
    • Fakultni Thomayerova nemocnice /ID# 232214 | Praha, Czechia, 140 59
    • Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 232472 | Berlin, Germany, 10117
    • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 239283 | Dresden, Germany, 01307
    • Praxis Dr. Gendolla /ID# 232474 | Essen, Germany, 45133
    • Universitaetsklinikum Essen /ID# 232478 | Essen, Germany, 45147
    • Kopfschmerzzentrum Frankfurt /ID# 234066 | Frankfurt am Main, Germany, 65929
    • Universitaetsklinikum Halle (Saale) /ID# 241506 | Halle (Saale), Germany, 06120
    • Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 232475 | Kassel, Germany, 34131
    • Schmerzklinik Kiel /ID# 232480 | Kiel, Germany, 24149
    • Neurologie Klinikum Großhadern /ID# 232479 | Munich, Germany, 81344
    • Universitaetsmedizin Rostock /ID# 232471 | Rostock, Germany, 18057
    • Hillel Yaffe Medical Center /ID# 232122 | Hadera, H_efa, Israel, 38100
    • Rambam Health Care Campus /ID# 238732 | Haifa, H_efa, Israel, 3109601
    • Maccabi Healthcare Services /ID# 238605 | Kfar Saba, HaMerkaz, Israel, 4420123
    • The Chaim Sheba Medical Center /ID# 232119 | Ramat Gan, Tel-Aviv, Israel, 5265601
    • Tel Aviv Sourasky Medical Center /ID# 232598 | Tel Aviv, Tel-Aviv, Israel, 6423906
    • Shaare Zedek Medical Center /ID# 239485 | Jerusalem, Yerushalayim, Israel, 91031
    • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 232355 | Lublin, Lubelskie, Poland, 20-582
    • Specjalistyczne Gabinety Sp. z o.o. /ID# 233526 | Krakow, Malopolskie, Poland, 30-539
    • Linden Sp. z o.o. sp.k. /ID# 245685 | Krakow, Malopolskie, Poland, 30-721
    • Instytut Zdrowia Dr Boczarska Jedynak /ID# 251857 | Oświęcim, Malopolskie, Poland, 32-600
    • Silmedic Sp. z o.o. /ID# 232358 | Katowice, Slaskie, Poland, 40-282
    • Solumed Centrum Medyczne /ID# 238446 | Poznan, Wielkopolskie, Poland, 60-529
    • Warszawska Klinika Sp. z o.o. /ID# 240612 | Warszawa, Poland, 02-119
    • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 241887 | Wroclaw, Poland, 52-210
    • Hospital Universitario Central de Asturias /ID# 232428 | Oviedo, Asturias, Spain, 33011
    • Clinica Universidad de Navarra - Pamplona /ID# 232270 | Pamplona, Navarra, Spain, 31008
    • Hospital Universitario Vall d'Hebron /ID# 232268 | Barcelona, Spain, 08035
    • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 233320 | Madrid, Spain, 28027
    • Hospital Universitario La Paz /ID# 232495 | Madrid, Spain, 28046
    • Hospital Clinico Universitario de Valladolid /ID# 232272 | Valladolid, Spain, 47003
    • Linkoping University Hospital /ID# 234040 | Linkoping, Sweden, 581 85
    • Skaneuro Privatmottagning /ID# 232175 | Lund, Sweden, 227 33
    • Neurology Clinic /ID# 234067 | Stockholm, Sweden, 114 33
    • Optimuskliniken /ID# 232174 | Upplands Vasby, Sweden, 194 61
    • Hull University Teaching Hospitals NHS Trust /ID# 242763 | Hull, East Riding Of Yorkshire, United Kingdom, HU3 2JZ
    • Queen Elizabeth University Hospital /ID# 244870 | Glasgow, United Kingdom, G51 4TF
    • NHS Highland /ID# 242855 | Inverness, United Kingdom, IV2 3UJ
    • Walton Centre /ID# 242857 | Liverpool, United Kingdom, L9 7LJ
    • St Pancras Clinical Research /ID# 242764 | London, United Kingdom, EC2Y 8EA
    Investigators

      More Information

      Additional Information

      Additional Relevant MeSH Terms

      • Migraine Disorders
      • Headache Disorders, Primary
      • Headache Disorders
      • Brain Diseases
      • Central Nervous System Diseases
      • Nervous System Diseases