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
🇺🇸Albuquerque, New Mexico, United States
Duplicate_University Of Cincinnati Medical Center /ID# 231739
🇺🇸Cincinnati, Ohio, United States
Fakultnà Nemocnice U Sv. Anny V Brně /ID# 232213
🇨🇿Brno, Brno-mesto, Czechia
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 239283
🇩🇪Dresden, Sachsen, Germany
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
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, 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 Beach, 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
Accellacare /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
🇺🇸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
Dent Neurosciences Research Center, Inc. /ID# 252442
🇺🇸Amherst, New York, United States
Montefiore Headache Center /ID# 232130
🇺🇸Bronx, New York, United States
Fieve Clinical Research, Inc. /ID# 231365
🇺🇸New York, 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
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
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
Fakultni Nemocnice Ostrava /ID# 232211
🇨🇿Ostrava, Ostrava-mesto, Czechia
Nemocnice Jihlava, prispevkova organizace /ID# 232164
🇨🇿Jihlava, Czechia
Clintrial s.r.o. /ID# 232208
🇨🇿Prague 10, Czechia
DADO MEDICAL s.r.o. /ID# 232157
🇨🇿Praha, Czechia
Axon Clinical, s.r.o. /ID# 232212
🇨🇿Praha, Czechia
Fakultni Thomayerova nemocnice /ID# 232214
🇨🇿Praha, Czechia
Universitaetsmedizin Rostock /ID# 232471
🇩🇪Rostock, Mecklenburg-Vorpommern, 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
Kopfschmerzzentrum Frankfurt /ID# 234066
🇩🇪Frankfurt am Main, Germany
Universitaetsklinikum Halle (Saale) /ID# 241506
🇩🇪Halle (Saale), Germany
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 232475
🇩🇪Kassel, Germany
Neurologie Klinikum Großhadern /ID# 232479
🇩🇪Munich, Germany
Hillel Yaffe Medical Center /ID# 232122
🇮🇱Hadera, H_efa, Israel
Rambam Health Care Campus /ID# 238732
🇮🇱Haifa, H_efa, Israel
Maccabi Healthcare Services /ID# 238605
🇮🇱Kfar Saba, HaMerkaz, 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
Shaare Zedek Medical Center /ID# 239485
🇮🇱Jerusalem, Yerushalayim, Israel
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 232355
🇵🇱Lublin, Lubelskie, Poland
Specjalistyczne Gabinety Sp. z o.o. /ID# 233526
🇵🇱Krakow, Malopolskie, Poland
Linden Sp. z o.o. sp.k. /ID# 245685
🇵🇱Krakow, Malopolskie, Poland
Instytut Zdrowia Dr Boczarska Jedynak /ID# 251857
🇵🇱Oświęcim, Malopolskie, Poland
Warszawska Klinika Sp. z o.o. /ID# 240612
🇵🇱Warszawa, Mazowieckie, Poland
Silmedic Sp. z o.o. /ID# 232358
🇵🇱Katowice, Slaskie, Poland
Solumed Centrum Medyczne /ID# 238446
🇵🇱Poznan, Wielkopolskie, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 241887
🇵🇱Wroclaw, Poland
Hospital Universitario Central de Asturias /ID# 232428
🇪🇸Oviedo, Asturias, Spain
Clinica Universidad de Navarra - Pamplona /ID# 232270
🇪🇸Pamplona, Navarra, 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
Linkoping University Hospital /ID# 234040
🇸🇪Linkoping, Ostergotlands Lan, Sweden
Skaneuro Privatmottagning /ID# 232175
🇸🇪Lund, Skane Lan, Sweden
Neurology Clinic /ID# 234067
🇸🇪Stockholm, Stockholms Lan, Sweden
Optimuskliniken /ID# 232174
🇸🇪Upplands Vasby, Sweden
Hull University Teaching Hospitals NHS Trust /ID# 242763
🇬🇧Hull, East Riding Of Yorkshire, United Kingdom
Queen Elizabeth University Hospital /ID# 244870
🇬🇧Glasgow, 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