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
Who is this study for? Patients with episodic migraine
What treatments are being studied? Botox
Status: Terminated
Location: See all (126) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Neurology and Neurodiagnostics of Alabama /ID# 231918
Hoover
Rehabilitation & Neurological Services /ID# 252441
Huntsville
Arkansas
Arkansas Clinical Research /ID# 231640
Little Rock
Woodland International Research Group /ID# 231492
Little Rock
Arizona
Alea Research /ID# 233329
Phoenix
Duplicate_Barrow Neurological Institute /ID# 231799
Phoenix
Clinical Endpoints /ID# 232625
Scottsdale
Tucson Neuroscience Research /ID# 232288
Tucson
California
Hope Clinical Research /ID# 232189
Canoga Park
Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351
Encino
Duplicate_Neuro Pain Medical Center /ID# 231478
Fresno
Sun Valley Research Center /ID# 231350
Imperial
Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 231908
Los Alamitos
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 231337
Newport Beach
Colorado
Colorado Springs Neurological Associates (CSNA) /ID# 230662
Colorado Springs
Summit Headache and Neurologic Institute /ID# 231809
Englewood
Advanced Neurosciences Research, LLC /ID# 230658
Fort Collins
Washington, D.c.
Georgetown University Hospital /ID# 232129
Washington D.c.
Florida
Neurology Offices of South Florida, PLLC /ID# 232281
Boca Raton
Nova Clinical Research, LLC /ID# 245256
Bradenton
Velocity Clinical Research - Hallandale Beach /ID# 232442
Hallandale
CNS Healthcare - Jacksonville /ID# 231345
Jacksonville
Brainstorm Research /ID# 243825
Miami
Sensible Healthcare /ID# 231340
Ocoee
Clinical Neuroscience Solutions, Inc /ID# 231362
Orlando
Pain Relief Centers /ID# 232415
Sun City Center
Accel Research Sites - Tampa Clinical Research Unit /ID# 231670
Tampa
Olympian Clinical Research - Tampa /ID# 239519
Tampa
University of South Florida- Neuroscience Institute /ID# 231808
Tampa
Premiere Research Institute - Palm Beach /ID# 230646
West Palm Beach
Conquest Research /ID# 232604
Winter Park
Georgia
Accel Research Sites Neurostudies /ID# 230665
Decatur
CenExcel iResearch LLC /ID# 231335
Decatur
Clinical Research Institute /ID# 239517
Stockbridge
Iowa
Duplicate_Accellacare - McFarland Clinic /ID# 231496
Ames
Idaho
Northwest Clinical Trials /ID# 230657
Boise
Velocity Clinical Research - Boise /ID# 230660
Meridian
Illinois
Robbins Headache Clinic /ID# 230970
Riverwoods
Indiana
Josephson-Wallack-Munshower Neurology - Northeast /ID# 230654
Indianapolis
Deaconess Clinic - Gateway Health Center /ID# 231329
Newburgh
Kansas
Kansas Institute of Research /ID# 231862
Overland Park
Louisiana
Ochsner Clinic Foundation /ID# 230645
Covington
Massachusetts
Boston Clinical Trials /ID# 231367
Boston
Brigham and Women's Faulkner Hospital /ID# 231865
Boston
Michigan
Michigan Headache & Neurological Institute (MHNI) /ID# 230659
Ann Arbor
Minnesota
Minneapolis Clinic of Neurology - Burnsville /ID# 231780
Burnsville
Missouri
StudyMetrix Research /ID# 230642
City Of Saint Peters
Clinvest Research LLC /ID# 252440
Springfield
North Carolina
Headache Wellness Center /ID# 230819
Greensboro
M3 Wake Research Inc. /ID# 232285
Raleigh
Neurology - Triad /ID# 231733
Winston-salem
New Mexico
Albuquerque Clinical Trials, Inc. /ID# 231101
Albuquerque
Nevada
Excel Clinical Research /ID# 232188
Las Vegas
Las Vegas Clinical Trials /ID# 232628
North Las Vegas
New York
Duplicate_Dent Neurosciences Research Center, Inc. /ID# 252442
Amherst
Fieve Clinical Research, Inc. /ID# 231365
New York
Montefiore Headache Center /ID# 232130
The Bronx
Upstate Clinical Research Associates /ID# 231343
Williamsville
Ohio
Duplicate_Duplicate_University Of Cincinnati Medical Center /ID# 231739
Cincinnati
Oklahoma
Cutting Edge Research Group /ID# 231095
Oklahoma City
IPS Research Company /ID# 231085
Oklahoma City
Lynn Institute of Oklahoma City /ID# 231349
Oklahoma City
Sooner Clinical Research /ID# 231096
Oklahoma City
Pennsylvania
Abington Neurological Associates - Abington /ID# 231798
Abington
Lehigh Center for Clinical Research /ID# 231355
Allentown
Suburban Research Associates - Media /ID# 231354
Media
Jefferson Hospital for Neuroscience /ID# 230664
Philadelphia
Duplicate_Frontier Clinical Research /ID# 232623
Smithfield
South Carolina
Clinical Trials of SC /ID# 231369
Charleston
Coastal Carolina Research Center - North Charleston /ID# 231353
North Charleston
Tennessee
Clinical Neuroscience Solutions - Memphis /ID# 231328
Memphis
Nashville Neuroscience Group /ID# 231642
Nashville
Texas
Austin Clinical Trial Partners /ID# 231092
Austin
Texas Neurology /ID# 230661
Dallas
NeuroCare Plus /ID# 252499
Houston
Virginia
Charlottesville Medical Research /ID# 231368
Charlottesville
Integrated Neurology Services - Falls Church /ID# 244776
Falls Church
Sentara Neurology Specialists - Virginia Beach /ID# 231341
Virginia Beach
Tidewater Integr Med Research /ID# 231359
Virginia Beach
Washington
Northwest Clinical Research Center /ID# 231336
Bellevue
Puget Sound Neurology /ID# 230640
Tacoma
West Virginia
Frontier Clinical Research - Kingwood /ID# 234127
Kingwood
Other Locations
Canada
CHAMP Clinic /ID# 231635
Calgary
Maritime Neurology /ID# 232048
Halifax
Clinique Neuro Levis /ID# 232049
Lévis
Toronto Memory Program /ID# 240006
Toronto
Vancouver Island Health Authority /ID# 231992
Victoria
Germany
Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 232472
Berlin
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 239283
Dresden
Praxis Dr. Gendolla /ID# 232474
Essen
Universitaetsklinikum Essen /ID# 232478
Essen
Duplicate_Kopfschmerzzentrum Frankfurt /ID# 234066
Frankfurt Am Main
Universitaetsklinikum Halle (Saale) /ID# 241506
Halle
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 232475
Kassel
Schmerzklinik Kiel /ID# 232480
Kiel
Duplicate_Neurologie Klinikum Großhadern /ID# 232479
Munich
Universitaetsmedizin Rostock /ID# 232471
Rostock
Israel
Hillel Yaffe Medical Center /ID# 232122
Hadera
Rambam Health Care Campus /ID# 238732
Haifa
Shaare Zedek Medical Center /ID# 239485
Jerusalem
Maccabi Healthcare Services /ID# 238605
Kfar Saba
The Chaim Sheba Medical Center /ID# 232119
Ramat Gan
Tel Aviv Sourasky Medical Center /ID# 232598
Tel Aviv
Poland
Silmedic Sp. z o.o. /ID# 232358
Katowice
Linden Sp. z o.o. sp.k. /ID# 245685
Krakow
Specjalistyczne Gabinety Sp. z o.o. /ID# 233526
Krakow
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 232355
Lublin
Instytut Zdrowia Dr Boczarska Jedynak /ID# 251857
Oświęcim
Solumed Centrum Medyczne /ID# 238446
Poznan
Warszawska Klinika Sp. z o.o. /ID# 240612
Warsaw
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 241887
Wroclaw
Spain
Hospital Universitario Vall d'Hebron /ID# 232268
Barcelona
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 233320
Madrid
Hospital Universitario La Paz /ID# 232495
Madrid
Hospital Universitario Central de Asturias /ID# 232428
Oviedo
Clinica Universidad de Navarra - Pamplona /ID# 232270
Pamplona
Hospital Clinico Universitario de Valladolid /ID# 232272
Valladolid
Sweden
Linkoping University Hospital /ID# 234040
Linköping
Skaneuro Privatmottagning /ID# 232175
Lund
Neurology Clinic /ID# 234067
Stockholm
Optimuskliniken /ID# 232174
Upplands Vasby
United Kingdom
Duplicate_Queen Elizabeth University Hospital /ID# 244870
Glasgow
Hull University Teaching Hospitals NHS Trust /ID# 242763
Hull
NHS Highland /ID# 242855
Inverness
Walton Centre /ID# 242857
Liverpool
St Pancras Clinical Research /ID# 242764
London
Time Frame
Start Date: 2021-11-05
Completion Date: 2024-11-06
Participants
Target number of participants: 775
Treatments
Placebo_comparator: Double-Blind Phase: Placebo
Participants received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Sponsors
Leads: AbbVie