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Episodic MigrainePhase 3NCT05028569

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

A Phase 3 study testing BOTOX in people with Episodic Migraine, run by AbbVie at 133 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Episodic Migraine
What is being tested?
BOTOX
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
775 participants
Where
133 sitesin 9 countries
Study dates
5 Nov 2021to 6 Nov 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

133 sites in 9 countries.

133 sites in 9 countries

United States82 sites

  • Abington Neurological Associates - Abington /ID# 231798

    Abington, Pennsylvania, 19001

  • Albuquerque Clinical Trials, Inc. /ID# 231101

    Albuquerque, New Mexico, 87102

  • Lehigh Center for Clinical Research /ID# 231355

    Allentown, Pennsylvania, 18103

  • Duplicate_Accellacare - McFarland Clinic /ID# 231496

    Ames, Iowa, 50010

  • Duplicate_Dent Neurosciences Research Center, Inc. /ID# 252442

    Amherst, New York, 14226

  • Michigan Headache & Neurological Institute (MHNI) /ID# 230659

    Ann Arbor, Michigan, 48104-5131

  • Austin Clinical Trial Partners /ID# 231092

    Austin, Texas, 78737

  • Northwest Clinical Research Center /ID# 231336

    Bellevue, Washington, 98007

  • Neurology Offices of South Florida, PLLC /ID# 232281

    Boca Raton, Florida, 33428-2231

  • Northwest Clinical Trials /ID# 230657

    Boise, Idaho, 83704

  • Brigham and Women's Faulkner Hospital /ID# 231865

    Boston, Massachusetts, 02130-3446

  • Boston Clinical Trials /ID# 231367

    Boston, Massachusetts, 02131-2515

  • Nova Clinical Research, LLC /ID# 245256

    Bradenton, Florida, 34209-4616

  • Minneapolis Clinic of Neurology - Burnsville /ID# 231780

    Burnsville, Minnesota, 55337-6732

  • Hope Clinical Research /ID# 232189

    Canoga Park, California, 91303

  • Clinical Trials of SC /ID# 231369

    Charleston, South Carolina, 29406

  • Charlottesville Medical Research /ID# 231368

    Charlottesville, Virginia, 22911

  • Duplicate_Duplicate_University Of Cincinnati Medical Center /ID# 231739

    Cincinnati, Ohio, 45267-0585

  • StudyMetrix Research /ID# 230642

    City of Saint Peters, Missouri, 63303

  • Colorado Springs Neurological Associates (CSNA) /ID# 230662

    Colorado Springs, Colorado, 80907

  • Ochsner Clinic Foundation /ID# 230645

    Covington, Louisiana, 70433-8107

  • Texas Neurology /ID# 230661

    Dallas, Texas, 75214

  • Accel Research Sites Neurostudies /ID# 230665

    Decatur, Georgia, 30030-2627

  • CenExcel iResearch LLC /ID# 231335

    Decatur, Georgia, 30030

  • Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351

    Encino, California, 91316

  • Summit Headache and Neurologic Institute /ID# 231809

    Englewood, Colorado, 80113-3781

  • Integrated Neurology Services - Falls Church /ID# 244776

    Falls Church, Virginia, 22043-2367

  • Advanced Neurosciences Research, LLC /ID# 230658

    Fort Collins, Colorado, 80528

  • Duplicate_Neuro Pain Medical Center /ID# 231478

    Fresno, California, 93710-5473

  • Headache Wellness Center /ID# 230819

    Greensboro, North Carolina, 27405

  • Velocity Clinical Research - Hallandale Beach /ID# 232442

    Hallandale, Florida, 33009-4427

  • Neurology and Neurodiagnostics of Alabama /ID# 231918

    Hoover, Alabama, 35244-5700

  • NeuroCare Plus /ID# 252499

    Houston, Texas, 77094-1385

  • Rehabilitation & Neurological Services /ID# 252441

    Huntsville, Alabama, 35805-4046

  • Sun Valley Research Center /ID# 231350

    Imperial, California, 92251-9401

  • Josephson-Wallack-Munshower Neurology - Northeast /ID# 230654

    Indianapolis, Indiana, 46256

  • CNS Healthcare - Jacksonville /ID# 231345

    Jacksonville, Florida, 32256-6039

  • Frontier Clinical Research - Kingwood /ID# 234127

    Kingwood, West Virginia, 26537-9797

  • Excel Clinical Research /ID# 232188

    Las Vegas, Nevada, 89109

  • Arkansas Clinical Research /ID# 231640

    Little Rock, Arkansas, 72205

  • Woodland International Research Group /ID# 231492

    Little Rock, Arkansas, 72211

  • Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 231908

    Los Alamitos, California, 90720

  • Suburban Research Associates - Media /ID# 231354

    Media, Pennsylvania, 19063-1760

  • Clinical Neuroscience Solutions - Memphis /ID# 231328

    Memphis, Tennessee, 38119

  • Velocity Clinical Research - Boise /ID# 230660

    Meridian, Idaho, 83642

  • Brainstorm Research /ID# 243825

    Miami, Florida, 33176-2315

  • Nashville Neuroscience Group /ID# 231642

    Nashville, Tennessee, 37203

  • Fieve Clinical Research, Inc. /ID# 231365

    New York, New York, 10017-1921

  • Deaconess Clinic - Gateway Health Center /ID# 231329

    Newburgh, Indiana, 47630

  • Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 231337

    Newport Beach, California, 92660

  • Coastal Carolina Research Center - North Charleston /ID# 231353

    North Charleston, South Carolina, 29405

  • Las Vegas Clinical Trials /ID# 232628

    North Las Vegas, Nevada, 89030-7187

  • Sensible Healthcare /ID# 231340

    Ocoee, Florida, 34761

  • IPS Research Company /ID# 231085

    Oklahoma City, Oklahoma, 73106

  • Lynn Institute of Oklahoma City /ID# 231349

    Oklahoma City, Oklahoma, 73112

  • Cutting Edge Research Group /ID# 231095

    Oklahoma City, Oklahoma, 73116-1423

  • Sooner Clinical Research /ID# 231096

    Oklahoma City, Oklahoma, 73116

  • Clinical Neuroscience Solutions, Inc /ID# 231362

    Orlando, Florida, 32801-2986

  • Kansas Institute of Research /ID# 231862

    Overland Park, Kansas, 66211-1363

  • Jefferson Hospital for Neuroscience /ID# 230664

    Philadelphia, Pennsylvania, 19107-5191

  • Alea Research /ID# 233329

    Phoenix, Arizona, 85012-2707

  • Duplicate_Barrow Neurological Institute /ID# 231799

    Phoenix, Arizona, 85013-4407

  • M3 Wake Research Inc. /ID# 232285

    Raleigh, North Carolina, 27612-8106

  • Robbins Headache Clinic /ID# 230970

    Riverwoods, Illinois, 60015-5711

  • Clinical Endpoints /ID# 232625

    Scottsdale, Arizona, 85258-4595

  • Duplicate_Frontier Clinical Research /ID# 232623

    Smithfield, Pennsylvania, 15478

  • Clinvest Research LLC /ID# 252440

    Springfield, Missouri, 65807

  • Clinical Research Institute /ID# 239517

    Stockbridge, Georgia, 30281

  • Pain Relief Centers /ID# 232415

    Sun City Center, Florida, 33573-6828

  • Puget Sound Neurology /ID# 230640

    Tacoma, Washington, 25328

  • University of South Florida- Neuroscience Institute /ID# 231808

    Tampa, Florida, 33613

  • Olympian Clinical Research - Tampa /ID# 239519

    Tampa, Florida, 33615

  • Accel Research Sites - Tampa Clinical Research Unit /ID# 231670

    Tampa, Florida, 33634

  • Montefiore Headache Center /ID# 232130

    The Bronx, New York, 10461-2720

  • Tucson Neuroscience Research /ID# 232288

    Tucson, Arizona, 85710-6152

  • Tidewater Integr Med Research /ID# 231359

    Virginia Beach, Virginia, 23451

  • Sentara Neurology Specialists - Virginia Beach /ID# 231341

    Virginia Beach, Virginia, 23456-0019

  • Georgetown University Hospital /ID# 232129

    Washington D.C., District of Columbia, 20007

  • Premiere Research Institute - Palm Beach /ID# 230646

    West Palm Beach, Florida, 33407-3209

  • Upstate Clinical Research Associates /ID# 231343

    Williamsville, New York, 14221-6046

  • Neurology - Triad /ID# 231733

    Winston-Salem, North Carolina, 27103-6984

  • Conquest Research /ID# 232604

    Winter Park, Florida, 32789

Other trials in United States

Germany10 sites

  • Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 232472

    Berlin, 10117

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 239283

    Dresden, Saxony, 01307

  • Praxis Dr. Gendolla /ID# 232474

    Essen, 45133

  • Universitaetsklinikum Essen /ID# 232478

    Essen, 45147

  • Duplicate_Kopfschmerzzentrum Frankfurt /ID# 234066

    Frankfurt am Main, Hesse, 65929

  • Universitaetsklinikum Halle (Saale) /ID# 241506

    Halle, 06120

  • Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 232475

    Kassel, 34131

  • Schmerzklinik Kiel /ID# 232480

    Kiel, Schleswig-Holstein, 24149

  • Duplicate_Neurologie Klinikum Großhadern /ID# 232479

    Munich, Bavaria, 81344

  • Universitaetsmedizin Rostock /ID# 232471

    Rostock, Mecklenburg-Vorpommern, 18057

Other trials in Germany

Poland8 sites

  • Silmedic Sp. z o.o. /ID# 232358

    Katowice, Silesian Voivodeship, 40-282

  • Specjalistyczne Gabinety Sp. z o.o. /ID# 233526

    Krakow, Lesser Poland Voivodeship, 30-539

  • Linden Sp. z o.o. sp.k. /ID# 245685

    Krakow, Lesser Poland Voivodeship, 30-721

  • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 232355

    Lublin, Lublin Voivodeship, 20-582

  • Instytut Zdrowia Dr Boczarska Jedynak /ID# 251857

    Oświęcim, Lesser Poland Voivodeship, 32-600

  • Solumed Centrum Medyczne /ID# 238446

    Poznan, Greater Poland Voivodeship, 60-529

  • Warszawska Klinika Sp. z o.o. /ID# 240612

    Warsaw, Masovian Voivodeship, 02-119

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 241887

    Wroclaw, 52-210

Other trials in Poland

Czechia7 sites

  • Fakultní Nemocnice U Sv. Anny V Brně /ID# 232213

    Brno, Brno-mesto, 656 91

  • Nemocnice Jihlava, prispevkova organizace /ID# 232164

    Jihlava, 586 01

  • Fakultni Nemocnice Ostrava /ID# 232211

    Ostrava, Ostrava-mesto, 708 52

  • Clintrial s.r.o. /ID# 232208

    Prague, 100 00

  • DADO MEDICAL s.r.o. /ID# 232157

    Prague, 120 00

  • Axon Clinical, s.r.o. /ID# 232212

    Prague, 140 00

  • Fakultni Thomayerova nemocnice /ID# 232214

    Prague, 140 59

Other trials in Czechia

Israel6 sites

  • Hillel Yaffe Medical Center /ID# 232122

    Hadera, Haifa District, 38100

  • Rambam Health Care Campus /ID# 238732

    Haifa, 3109601

  • Shaare Zedek Medical Center /ID# 239485

    Jerusalem, Jerusalem, 91031

  • Maccabi Healthcare Services /ID# 238605

    Kfar Saba, Central District, 4420123

  • The Chaim Sheba Medical Center /ID# 232119

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 232598

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Spain6 sites

  • Hospital Universitario Vall d'Hebron /ID# 232268

    Barcelona, 08035

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 233320

    Madrid, 28027

  • Hospital Universitario La Paz /ID# 232495

    Madrid, 28046

  • Hospital Universitario Central de Asturias /ID# 232428

    Oviedo, Principality of Asturias, 33011

  • Clinica Universidad de Navarra - Pamplona /ID# 232270

    Pamplona, Navarre, 31008

  • Hospital Clinico Universitario de Valladolid /ID# 232272

    Valladolid, 47003

Other trials in Spain

Canada5 sites

  • CHAMP Clinic /ID# 231635

    Calgary, Alberta, T3M 1M4

  • Maritime Neurology /ID# 232048

    Halifax, Nova Scotia, B3R 1V9

  • Clinique Neuro Levis /ID# 232049

    Lévis, Quebec, G6W 0M5

  • Toronto Memory Program /ID# 240006

    Toronto, Ontario, M3B 2S7

  • Vancouver Island Health Authority /ID# 231992

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

United Kingdom5 sites

  • Duplicate_Queen Elizabeth University Hospital /ID# 244870

    Glasgow, Glasgow City, G51 4TF

  • Hull University Teaching Hospitals NHS Trust /ID# 242763

    Hull, East Riding Of Yorkshire, HU3 2JZ

  • NHS Highland /ID# 242855

    Inverness, IV2 3UJ

  • Walton Centre /ID# 242857

    Liverpool, L9 7LJ

  • St Pancras Clinical Research /ID# 242764

    London, EC2Y 8EA

Other trials in United Kingdom

Sweden4 sites

  • Linkoping University Hospital /ID# 234040

    Linköping, Östergötland County, 581 85

  • Skaneuro Privatmottagning /ID# 232175

    Lund, Skåne County, 227 33

  • Neurology Clinic /ID# 234067

    Stockholm, Stockholm County, 114 33

  • Optimuskliniken /ID# 232174

    Upplands Vasby, 194 61

Other trials in Sweden

About this study

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

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.

Read more

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.

Being tested
BOTOX, Placebo
Keywords
Migraine, Episodic Migraine, BOTOX, Botulinum Toxin Type A
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BOTOXDrug

    Also called Botulinum Toxin Type A

    Intramuscular Injection

  • PlaceboDrug

    Intramuscular Injection

Study groups in NCT05028569
Study groupRoleWhat they receive
Double-Blind Phase: PlaceboPlacebo comparatorParticipants received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12.
Receives: Drug: Placebo
Double-Blind Phase: BOTOX 155 UExperimentalParticipants received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12.
Receives: Drug: BOTOX
Double-Blind Phase: BOTOX 195 UExperimentalParticipants received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12.
Receives: Drug: BOTOX
Open-Label Phase: BOTOX 195 UExperimentalEligible participants received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36.
Receives: Drug: BOTOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6

    The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.

    Measured: Baseline, Months 5-6

  2. Number of Participants With Treatment-Emergent Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

    Measured: Double-Blind Phase (Week 0-24); Open-Label Phase (Week 24-48)

Secondary outcomes (6)

  1. Change From Baseline in the Frequency of Monthly Headache Days Across Months 5 and 6

    The frequency of monthly headache days across Months 5 and 6 is calculated by taking the 2-month average of monthly headache days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.

    Measured: Baseline, Months 5-6

  2. Percentage of Participants With ≥ 50% Reduction From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6

    The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. The responder status of 50% reduction from Baseline is defined as a participant with at least a 50% reduction from Baseline in the 2-month average of monthly migraine days over Months 5 and 6.

    Measured: Baseline, Months 5-6

  3. Change From Baseline in the Frequency of Monthly Acute Headache Medication Days Across Months 5 and 6

    Monthly acute headache medication days across Months 5 and 6 is calculated by taking the 2-month average of monthly acute headache medication days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.

    Measured: Baseline, Months 5-6

  4. Change From Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score At Month 6

    The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine over the past 4 weeks. It is divided into 3 domains, and the Role Function Restrictive (RFR) 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". Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. Positive changes from Baseline indicate improvement.

    Measured: Baseline, Month 6

  5. Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score Across Months 5 and 6

    AIM-D Physical Impairment Domain score is calculated based on the summation of AIM-D items 6-9. Participants answer each question based on the level of difficulty experienced in the 24 hours prior, with "during your headache" indicated for when they reported a headache, using a 6-point rating scale ranging from "not difficult at all" to "extremely difficult". The raw daily score is transformed to a 0-100 scale, and the monthly score is calculated using the average daily scores, where a higher score indicates worse physical impairment. AIM-D Physical Impairment domain score across Months 5 and 6 is calculated by taking the 2-month average of AIM-D Physical Impairment domain scores over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.

    Measured: Baseline, Months 5-6

  6. Change From Baseline in the Total 6-item Headache Impact Test (HIT-6) Score Across Months 5 and 6

    The HIT-6 is a 6-item assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home and in social situations. It assesses the effect that headaches have on normal daily life and the subject's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses, each of which is assigned a score ranging from 6 points (never) to 13 points (always). The Total 6-item Headache Impact Test (HIT-6) score across Months 5 and 6 is calculated by taking the 2-month average of total 6-item Headache Impact Test (HIT-6) scores over Months 5 and 6. Negative changes from Baseline in the HIT-6 score indicate improvement.

    Measured: Baseline, Months 5-6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2021
  2. Study start5 Nov 2021
  3. Primary completion6 Nov 2024
  4. Study completion6 Nov 2024

Why it stopped: The study was terminated early due to lack of efficacy from the primary analysis results.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
775 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05028569
Sponsor's protocol ID
M21-307
Other IDs
2021-001979-16
Status last verified
Nov 2025
First submitted
25 Aug 2021
Last updated
9 Dec 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BOTOX in people with Episodic Migraine, run by AbbVie at 133 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in United States, Germany, Poland, Czechia, Israel and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6 (time frame: Baseline, Months 5-6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05028569.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.

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