Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine

Episodic Migraine Clinical Trial

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

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
• Start date: November 5, 2021
• Est. completion date: November 25, 2024

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• 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 25, 2024
• Est. primary completion date: November 25, 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, 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.

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders

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	Silmedic Sp. z o.o. /ID# 232358	Katowice	Slaskie
Poland	Linden Sp. z o.o. sp.k. /ID# 245685	Krakow	Malopolskie
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 /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 - Northeast /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	Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /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 - North Charleston /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 Institute of Oklahoma City /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	Duplicate_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- Neuroscience Institute /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
Primary	Number of Participants with Treatment Emergent Adverse Events (AEs)	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.	Up to approximately 52 weeks
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

External Links

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