Clinical trial NCT05028569: Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Episodic Migraine
Keywords: Migraine
Episodic Migraine
BOTOX
Botulinum Toxin Type A
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-08-31
Enrollment: 775
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in the Frequency of Monthly Migraine Days
timeFrame: 6 Months
measure: Number of Participants with Treatment Emergent Adverse Events (AEs)
timeFrame: Up to approximately 52 weeks
Secondary outcomes:
measure: Change From Baseline in the Frequency of Monthly Headache Days
timeFrame: 6 Months
measure: Responder Status of 50% Reduction From Baseline in the Frequency of Monthly Migraine Days
timeFrame: 6 Months
measure: Change From Baseline in the Frequency of Monthly Acute Headache Medication Days
timeFrame: 6 Months
measure: Change From Baseline in Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score
timeFrame: 6 Months
measure: Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score
timeFrame: 6 Months
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Neurology and Neurodiagnostics of Alabama /ID# 231918
state: Alabama
city: Huntsville
country: United States
facility: Rehabilitation & Neurological Services /ID# 252441
state: Alabama
city: Phoenix
country: United States
facility: Alea Research /ID# 233329
state: Arizona
city: Phoenix
country: United States
facility: Duplicate_Barrow Neurological Institute /ID# 231799
state: Arizona
city: Scottsdale
country: United States
facility: Clinical Endpoints /ID# 232625
state: Arizona
city: Tucson
country: United States
facility: Tucson Neuroscience Research /ID# 232288
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Clinical Research /ID# 231640
state: Arkansas
city: Little Rock
country: United States
facility: Woodland International Research Group /ID# 231492
state: Arkansas
city: Canoga Park
country: United States
facility: Hope Clinical Research /ID# 232189
state: California
city: Encino
country: United States
facility: Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351
state: California
city: Fresno
country: United States
facility: Neuro Pain Medical Center /ID# 231478
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center /ID# 231350
state: California
city: Los Alamitos
country: United States
facility: Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 231908
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 231337
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates (CSNA) /ID# 230662
state: Colorado
city: Englewood
country: United States
facility: Summit Headache and Neurologic Institute /ID# 231809
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research, LLC /ID# 230658
state: Colorado
city: Washington
country: United States
facility: Georgetown University Hospital /ID# 232129
state: District of Columbia
city: Boca Raton
country: United States
facility: Neurology Offices of South Florida, PLLC /ID# 232281
state: Florida
city: Bradenton
country: United States
facility: Nova Clinical Research, LLC /ID# 245256
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research - Hallandale Beach /ID# 232442
state: Florida
city: Jacksonville
country: United States
facility: CNS Healthcare - Jacksonville /ID# 231345
state: Florida
city: Miami
country: United States
facility: Brainstorm Research /ID# 243825
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare /ID# 231340
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc /ID# 231362
state: Florida
city: Sun City Center
country: United States
facility: Pain Relief Centers /ID# 232415
state: Florida
city: Tampa
country: United States
facility: University of South Florida- Neuroscience Institute /ID# 231808
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research - Tampa /ID# 239519
state: Florida
city: Tampa
country: United States
facility: Accel Research Sites - Tampa Clinical Research Unit /ID# 231670
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute - Palm Beach /ID# 230646
state: Florida
city: Winter Park
country: United States
facility: Conquest Research /ID# 232604
state: Florida
city: Decatur
country: United States
facility: Accel Research Sites Neurostudies /ID# 230665
state: Georgia
city: Decatur
country: United States
facility: CenExcel iResearch LLC /ID# 231335
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Institute /ID# 239517
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials /ID# 230657
state: Idaho
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise /ID# 230660
state: Idaho
city: Riverwoods
country: United States
facility: Robbins Headache Clinic /ID# 230970
state: Illinois
city: Indianapolis
country: United States
facility: Josephson-Wallack-Munshower Neurology - Northeast /ID# 230654
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Clinic - Gateway Health Center /ID# 231329
state: Indiana
city: Ames
country: United States
facility: Accellacare /ID# 231496
state: Iowa
city: Overland Park
country: United States
facility: Kansas Institute of Research /ID# 231862
state: Kansas
city: Covington
country: United States
facility: Ochsner Clinic Foundation /ID# 230645
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Faulkner Hospital /ID# 231865
state: Massachusetts
city: Boston
country: United States
facility: Boston Clinical Trials /ID# 231367
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Headache & Neurological Institute (MHNI) /ID# 230659
state: Michigan
city: Burnsville
country: United States
facility: Minneapolis Clinic of Neurology - Burnsville /ID# 231780
state: Minnesota
city: Saint Peters
country: United States
facility: StudyMetrix Research /ID# 230642
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC /ID# 252440
state: Missouri
city: Las Vegas
country: United States
facility: Excel Clinical Research /ID# 232188
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials /ID# 232628
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc. /ID# 231101
state: New Mexico
city: Amherst
country: United States
facility: Dent Neurosciences Research Center, Inc. /ID# 252442
state: New York
city: Bronx
country: United States
facility: Montefiore Headache Center /ID# 232130
state: New York
city: New York
country: United States
facility: Fieve Clinical Research, Inc. /ID# 231365
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates /ID# 231343
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center /ID# 230819
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research Inc. /ID# 232285
state: North Carolina
city: Winston-Salem
country: United States
facility: Neurology - Triad /ID# 231733
state: North Carolina
city: Cincinnati
country: United States
facility: Duplicate_University Of Cincinnati Medical Center /ID# 231739
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company /ID# 231085
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Institute of Oklahoma City /ID# 231349
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group /ID# 231095
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research /ID# 231096
state: Oklahoma
city: Abington
country: United States
facility: Abington Neurological Associates - Abington /ID# 231798
state: Pennsylvania
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research /ID# 231355
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates - Media /ID# 231354
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Hospital for Neuroscience /ID# 230664
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research /ID# 232623
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Trials of SC /ID# 231369
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center - North Charleston /ID# 231353
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions - Memphis /ID# 231328
state: Tennessee
city: Nashville
country: United States
facility: Nashville Neuroscience Group /ID# 231642
state: Tennessee
city: Austin
country: United States
facility: Austin Clinical Trial Partners /ID# 231092
state: Texas
city: Dallas
country: United States
facility: Texas Neurology /ID# 230661
state: Texas
city: Houston
country: United States
facility: NeuroCare Plus /ID# 252499
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research /ID# 231368
state: Virginia
city: Falls Church
country: United States
facility: Integrated Neurology Services - Falls Church /ID# 244776
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Integr Med Research /ID# 231359
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Neurology Specialists - Virginia Beach /ID# 231341
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center /ID# 231336
state: Washington
city: Tacoma
country: United States
facility: Puget Sound Neurology /ID# 230640
state: Washington
city: Kingwood
country: United States
facility: Frontier Clinical Research - Kingwood /ID# 234127
state: West Virginia
city: Calgary
country: Canada
facility: CHAMP Clinic /ID# 231635
state: Alberta
city: Victoria
country: Canada
facility: Vancouver Island Health Authority /ID# 231992
state: British Columbia
city: Halifax
country: Canada
facility: Maritime Neurology /ID# 232048
state: Nova Scotia
city: Toronto
country: Canada
facility: Toronto Memory Program /ID# 240006
state: Ontario
city: Lévis
country: Canada
facility: Clinique Neuro Levis /ID# 232049
state: Quebec
city: Brno
country: Czechia
facility: Fakultní Nemocnice U Sv. Anny V Brně /ID# 232213
state: Brno-mesto
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava /ID# 232211
state: Ostrava-mesto
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava, prispevkova organizace /ID# 232164
city: Prague 10
country: Czechia
facility: Clintrial s.r.o. /ID# 232208
city: Praha
country: Czechia
facility: DADO MEDICAL s.r.o. /ID# 232157
city: Praha
country: Czechia
facility: Axon Clinical, s.r.o. /ID# 232212
city: Praha
country: Czechia
facility: Fakultni Thomayerova nemocnice /ID# 232214
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock /ID# 232471
state: Mecklenburg-Vorpommern
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden /ID# 239283
state: Sachsen
city: Kiel
country: Germany
facility: Schmerzklinik Kiel /ID# 232480
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 232472
city: Essen
country: Germany
facility: Praxis Dr. Gendolla /ID# 232474
city: Essen
country: Germany
facility: Universitaetsklinikum Essen /ID# 232478
city: Frankfurt am Main
country: Germany
facility: Kopfschmerzzentrum Frankfurt /ID# 234066
city: Halle (Saale)
country: Germany
facility: Universitaetsklinikum Halle (Saale) /ID# 241506
city: Kassel
country: Germany
facility: Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 232475
city: Munich
country: Germany
facility: Neurologie Klinikum Großhadern /ID# 232479
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center /ID# 232122
state: H_efa
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 238732
state: H_efa
city: Kfar Saba
country: Israel
facility: Maccabi Healthcare Services /ID# 238605
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 232119
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 232598
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 239485
state: Yerushalayim
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 232355
state: Lubelskie
city: Krakow
country: Poland
facility: Specjalistyczne Gabinety Sp. z o.o. /ID# 233526
state: Malopolskie
city: Krakow
country: Poland
facility: Linden Sp. z o.o. sp.k. /ID# 245685
state: Malopolskie
city: Oświęcim
country: Poland
facility: Instytut Zdrowia Dr Boczarska Jedynak /ID# 251857
state: Malopolskie
city: Warszawa
country: Poland
facility: Warszawska Klinika Sp. z o.o. /ID# 240612
state: Mazowieckie
city: Katowice
country: Poland
facility: Silmedic Sp. z o.o. /ID# 232358
state: Slaskie
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne /ID# 238446
state: Wielkopolskie
city: Wroclaw
country: Poland
facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 241887
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias /ID# 232428
state: Asturias
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona /ID# 232270
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 232268
city: Madrid
country: Spain
facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 233320
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 232495
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid /ID# 232272
city: Linkoping
country: Sweden
facility: Linkoping University Hospital /ID# 234040
state: Ostergotlands Lan
city: Lund
country: Sweden
facility: Skaneuro Privatmottagning /ID# 232175
state: Skane Lan
city: Stockholm
country: Sweden
facility: Neurology Clinic /ID# 234067
state: Stockholms Lan
city: Upplands Vasby
country: Sweden
facility: Optimuskliniken /ID# 232174
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust /ID# 242763
state: East Riding Of Yorkshire
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital /ID# 244870
city: Inverness
country: United Kingdom
facility: NHS Highland /ID# 242855
city: Liverpool
country: United Kingdom
facility: Walton Centre /ID# 242857
city: London
country: United Kingdom
facility: St Pancras Clinical Research /ID# 242764
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: