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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05028569
Other study ID # M21-307
Secondary ID 2021-001979-16
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 5, 2021
Est. completion date November 21, 2024

Study information

Verified date January 2024
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 775
Est. completion date November 21, 2024
Est. primary completion date June 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache. - History of headache attributed to another disorder (eg, secondary headaches), except medication overuse headache. - History of an inadequate response to >4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine. - Pregnant or nursing females.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BOTOX
Intramuscular Injection
Placebo
Intramuscular Injection

Locations

Country Name City State
Canada CHAMP Clinic /ID# 231635 Calgary Alberta
Canada Maritime Neurology /ID# 232048 Halifax Nova Scotia
Canada Clinique Neuro Levis /ID# 232049 Lévis Quebec
Canada Toronto Memory Program /ID# 240006 Toronto Ontario
Canada Vancouver Island Health Authority /ID# 231992 Victoria British Columbia
Czechia Fakultni nemocnice u sv. Anny v Brne /ID# 232213 Brno
Czechia Nemocnice Jihlava, prispevkova organizace /ID# 232164 Jihlava
Czechia Fakultni Nemocnice Ostrava /ID# 232211 Ostrava
Czechia Clintrial s.r.o. /ID# 232208 Prague 10
Czechia Axon Clinical, s.r.o. /ID# 232212 Praha
Czechia DADO MEDICAL s.r.o. /ID# 232157 Praha
Czechia Fakultni Thomayerova nemocnice /ID# 232214 Praha
Germany Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 232472 Berlin
Germany Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 239283 Dresden
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 Schmerzklinik Kiel /ID# 232480 Kiel
Germany Neurologie Klinikum Großhadern /ID# 232479 Munich
Germany Universitaetsmedizin Rostock /ID# 232471 Rostock
Israel Hillel Yaffe Medical Center /ID# 232122 Hadera H_efa
Israel Rambam Health Care Campus /ID# 238732 Haifa H_efa
Israel Shaare Zedek Medical Center /ID# 239485 Jerusalem Yerushalayim
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
Poland Linden Sp. z o.o. sp.k. /ID# 245685 Cracow
Poland Silmedic Sp. z o.o. /ID# 232358 Katowice Slaskie
Poland Specjalistyczne Gabinety Sp. z o.o. /ID# 233526 Krakow Malopolskie
Poland Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 232355 Lublin Lubelskie
Poland Instytut Zdrowia Dr Boczarska-Jedynak Sp. Z O.O. Sp.K. /Id# 251857 Oswiecim Malopolskie
Poland Solumed Centrum Medyczne /ID# 238446 Poznan Wielkopolskie
Poland Warszawska Klinika Sp. z o.o. /ID# 240612 Warszawa
Poland MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 241887 Wroclaw
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 Universitario Central de Asturias /ID# 232428 Oviedo Asturias
Spain CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 232270 Pamplona Navarra
Spain Hospital Clinico Universitario de Valladolid /ID# 232272 Valladolid
Sweden Linkoping University Hospital /ID# 234040 Linkoping
Sweden Skaneuro Privatmottagning /ID# 232175 Lund
Sweden Neurology Clinic /ID# 234067 Stockholm
Sweden Optimuskliniken /ID# 232174 Upplands Vasby
United Kingdom Queen Elizabeth University Hospital /ID# 244870 Glasgow
United Kingdom Hull University Teaching Hospitals NHS Trust /ID# 242763 Hull East Riding Of Yorkshire
United Kingdom NHS Highland /ID# 242855 Inverness
United Kingdom Walton Centre /ID# 242857 Liverpool
United Kingdom St Pancras Clinical Research /ID# 242764 London
United States Abington Neurological Associates - Abington /ID# 231798 Abington Pennsylvania
United States Albuquerque Clinical Trials, Inc /ID# 231101 Albuquerque New Mexico
United States Lehigh Center for Clinical Research /ID# 231355 Allentown Pennsylvania
United States Accellacare /ID# 231496 Ames Iowa
United States Dent Neurosciences Research Center, Inc. /ID# 252442 Amherst New York
United States Michigan Headache & Neurological Institute (MHNI) /ID# 230659 Ann Arbor Michigan
United States Austin Clinical Trial Partners /ID# 231092 Austin Texas
United States Northwest Clinical Research Center /ID# 231336 Bellevue Washington
United States Neurology Offices of South Florida, PLLC /ID# 232281 Boca Raton Florida
United States Northwest Clinical Trials /ID# 230657 Boise Idaho
United States Boston Clinical Trials /ID# 231367 Boston Massachusetts
United States Brigham and Women's Faulkner Hospital /ID# 231865 Boston Massachusetts
United States Nova Clinical Research, LLC /ID# 245256 Bradenton Florida
United States Montefiore Headache Center /ID# 232130 Bronx New York
United States Minneapolis Clinic of Neurology - Burnsville /ID# 231780 Burnsville Minnesota
United States Hope Clinical Research /ID# 232189 Canoga Park California
United States Clinical Trials of SC /ID# 231369 Charleston South Carolina
United States Charlottesville Medical Research /ID# 231368 Charlottesville Virginia
United States University of Cincinnati /ID# 231739 Cincinnati Ohio
United States Colorado Springs Neurological Associates (CSNA) /ID# 230662 Colorado Springs Colorado
United States Ochsner Clinic Foundation /ID# 230645 Covington Louisiana
United States Texas Neurology /ID# 230661 Dallas Texas
United States Accel Research Sites Neurostudies /ID# 230665 Decatur Georgia
United States CenExcel iResearch LLC /ID# 231335 Decatur Georgia
United States Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351 Encino California
United States Summit Headache and Neurologic Institute /ID# 231809 Englewood Colorado
United States Integrated Neurology Services - Falls Church /ID# 244776 Falls Church Virginia
United States Advanced Neurosciences Research, LLC /ID# 230658 Fort Collins Colorado
United States Neuro Pain Medical Center /ID# 231478 Fresno California
United States Headache Wellness Center /ID# 230819 Greensboro North Carolina
United States Velocity Clinical Research - Hallandale Beach /ID# 232442 Hallandale Beach Florida
United States Neurology and Neurodiagnostics of Alabama /ID# 231918 Hoover Alabama
United States NeuroCare Plus /ID# 252499 Houston Texas
United States Rehabilitation & Neurological Services /ID# 252441 Huntsville Alabama
United States Sun Valley Research Center /ID# 231350 Imperial California
United States Josephson-Wallack-Munshower Neurology - PC /ID# 230654 Indianapolis Indiana
United States CNS Healthcare - Jacksonville /ID# 231345 Jacksonville Florida
United States Frontier Clinical Research - Kingwood /ID# 234127 Kingwood West Virginia
United States Excel Clinical Research /ID# 232188 Las Vegas Nevada
United States Arkansas Clinical Research /ID# 231640 Little Rock Arkansas
United States Woodland International Research Group /ID# 231492 Little Rock Arkansas
United States Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 231908 Los Alamitos California
United States Suburban Research Associates - Media /ID# 231354 Media Pennsylvania
United States Clinical Neuroscience Solutions - Memphis /ID# 231328 Memphis Tennessee
United States Velocity Clinical Research - Boise /ID# 230660 Meridian Idaho
United States Brainstorm Research /ID# 243825 Miami Florida
United States Nashville Neuroscience Group /ID# 231642 Nashville Tennessee
United States Fieve Clinical Research, Inc. /ID# 231365 New York New York
United States Deaconess Clinic - Gateway Health Center /ID# 231329 Newburgh Indiana
United States Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 231337 Newport Beach California
United States Coastal Carolina Research Center /ID# 231353 North Charleston South Carolina
United States Las Vegas Clinical Trials /ID# 232628 North Las Vegas Nevada
United States Sensible Healthcare /ID# 231340 Ocoee Florida
United States Cutting Edge Research Group /ID# 231095 Oklahoma City Oklahoma
United States IPS Research Company /ID# 231085 Oklahoma City Oklahoma
United States Lynn Health Science Institute (LHSI) /ID# 231349 Oklahoma City Oklahoma
United States Sooner Clinical Research /ID# 231096 Oklahoma City Oklahoma
United States Clinical Neuroscience Solutions, Inc /ID# 231362 Orlando Florida
United States Kansas Institute of Research /ID# 231862 Overland Park Kansas
United States Jefferson Hospital for Neuroscience /ID# 230664 Philadelphia Pennsylvania
United States Alea Research /ID# 233329 Phoenix Arizona
United States Barrow Neurological Institute /ID# 231799 Phoenix Arizona
United States M3 Wake Research Inc. /ID# 232285 Raleigh North Carolina
United States Robbins Headache Clinic /ID# 230970 Riverwoods Illinois
United States StudyMetrix Research /ID# 230642 Saint Peters Missouri
United States Clinical Endpoints /ID# 232625 Scottsdale Arizona
United States Frontier Clinical Research /ID# 232623 Smithfield Pennsylvania
United States Clinvest Research LLC /ID# 252440 Springfield Missouri
United States Clinical Research Institute /ID# 239517 Stockbridge Georgia
United States Pain Relief Centers /ID# 232415 Sun City Center Florida
United States Puget Sound Neurology /ID# 230640 Tacoma Washington
United States Accel Research Sites - Tampa Clinical Research Unit /ID# 231670 Tampa Florida
United States Olympian Clinical Research - Tampa /ID# 239519 Tampa Florida
United States University of South Florida /ID# 231808 Tampa Florida
United States Tucson Neuroscience Research /ID# 232288 Tucson Arizona
United States Sentara Neurology Specialists - Virginia Beach /ID# 231341 Virginia Beach Virginia
United States Tidewater Integr Med Research /ID# 231359 Virginia Beach Virginia
United States Georgetown University Hospital /ID# 232129 Washington District of Columbia
United States Premiere Research Institute - Palm Beach /ID# 230646 West Palm Beach Florida
United States Upstate Clinical Research Associates /ID# 231343 Williamsville New York
United States Neurology - Triad /ID# 231733 Winston-Salem North Carolina
United States Conquest Research /ID# 232604 Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Israel,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in the Frequency of Monthly Migraine Days Change from baseline in the frequency of monthly migraine days (i.e., migraine or probable migraine headache days) will be assessed. 6 Months
Secondary Change From Baseline in the Frequency of Monthly Headache Days Change from baseline in the frequency of monthly headache days will be assessed. 6 Months
Secondary Responder Status of 50% Reduction From Baseline in the Frequency of Monthly Migraine Days Percentage of participants achieving 50% reduction from baseline in the frequency of monthly migraine days will be assessed. 6 Months
Secondary Change From Baseline in the Frequency of Monthly Acute Headache Medication Days The change from baseline in acute migraine medication use days will be assessed. 6 Months
Secondary Change From Baseline in Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score 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". 6 Months
Secondary Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score 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". 6 Months
Secondary Change From Baseline in the Frequency of Monthly Neck Pain Days Associated With Headache Among Participants Who Report at least 1 day of Neck Pain Associated With Headache During Baseline Change from baseline in the frequency of monthly neck pain days associated with headache will be assessed among participants who report at least 1 day of neck pain associated with headache during baseline. 6 Months
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