Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
Public ClinicalTrials.gov record NCT05028569. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05028569
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 775 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 5, 2021 (Actual)
- Primary completion
- Nov 6, 2024 (Actual)
- Completion
- Nov 6, 2024 (Actual)
- Last update posted
- Dec 9, 2025
2021 – 2024
United States locations
- U.S. sites
- 82
- U.S. states
- 31
- U.S. cities
- 72
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neurology and Neurodiagnostics of Alabama /ID# 231918 | Hoover | Alabama | 35244-5700 | — |
| Rehabilitation & Neurological Services /ID# 252441 | Huntsville | Alabama | 35805-4046 | — |
| Alea Research /ID# 233329 | Phoenix | Arizona | 85012-2707 | — |
| Duplicate_Barrow Neurological Institute /ID# 231799 | Phoenix | Arizona | 85013-4407 | — |
| Clinical Endpoints /ID# 232625 | Scottsdale | Arizona | 85258-4595 | — |
| Tucson Neuroscience Research /ID# 232288 | Tucson | Arizona | 85710-6152 | — |
| Arkansas Clinical Research /ID# 231640 | Little Rock | Arkansas | 72205 | — |
| Woodland International Research Group /ID# 231492 | Little Rock | Arkansas | 72211 | — |
| Hope Clinical Research /ID# 232189 | Canoga Park | California | 91303 | — |
| Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 231351 | Encino | California | 91316 | — |
| Duplicate_Neuro Pain Medical Center /ID# 231478 | Fresno | California | 93710-5473 | — |
| Sun Valley Research Center /ID# 231350 | Imperial | California | 92251-9401 | — |
| Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 231908 | Los Alamitos | California | 90720 | — |
| Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 231337 | Newport Beach | California | 92660 | — |
| Colorado Springs Neurological Associates (CSNA) /ID# 230662 | Colorado Springs | Colorado | 80907 | — |
| Summit Headache and Neurologic Institute /ID# 231809 | Englewood | Colorado | 80113-3781 | — |
| Advanced Neurosciences Research, LLC /ID# 230658 | Fort Collins | Colorado | 80528 | — |
| Georgetown University Hospital /ID# 232129 | Washington D.C. | District of Columbia | 20007 | — |
| Neurology Offices of South Florida, PLLC /ID# 232281 | Boca Raton | Florida | 33428-2231 | — |
| Nova Clinical Research, LLC /ID# 245256 | Bradenton | Florida | 34209-4616 | — |
| Velocity Clinical Research - Hallandale Beach /ID# 232442 | Hallandale | Florida | 33009-4427 | — |
| CNS Healthcare - Jacksonville /ID# 231345 | Jacksonville | Florida | 32256-6039 | — |
| Brainstorm Research /ID# 243825 | Miami | Florida | 33176-2315 | — |
| Sensible Healthcare /ID# 231340 | Ocoee | Florida | 34761 | — |
| Clinical Neuroscience Solutions, Inc /ID# 231362 | Orlando | Florida | 32801-2986 | — |
| Pain Relief Centers /ID# 232415 | Sun City Center | Florida | 33573-6828 | — |
| 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 | — |
| Premiere Research Institute - Palm Beach /ID# 230646 | West Palm Beach | Florida | 33407-3209 | — |
| Conquest Research /ID# 232604 | Winter Park | Florida | 32789 | — |
| Accel Research Sites Neurostudies /ID# 230665 | Decatur | Georgia | 30030-2627 | — |
| CenExcel iResearch LLC /ID# 231335 | Decatur | Georgia | 30030 | — |
| Clinical Research Institute /ID# 239517 | Stockbridge | Georgia | 30281 | — |
| Northwest Clinical Trials /ID# 230657 | Boise | Idaho | 83704 | — |
| Velocity Clinical Research - Boise /ID# 230660 | Meridian | Idaho | 83642 | — |
| Robbins Headache Clinic /ID# 230970 | Riverwoods | Illinois | 60015-5711 | — |
| Josephson-Wallack-Munshower Neurology - Northeast /ID# 230654 | Indianapolis | Indiana | 46256 | — |
| Deaconess Clinic - Gateway Health Center /ID# 231329 | Newburgh | Indiana | 47630 | — |
| Duplicate_Accellacare - McFarland Clinic /ID# 231496 | Ames | Iowa | 50010 | — |
| Kansas Institute of Research /ID# 231862 | Overland Park | Kansas | 66211-1363 | — |
| Ochsner Clinic Foundation /ID# 230645 | Covington | Louisiana | 70433-8107 | — |
| Brigham and Women's Faulkner Hospital /ID# 231865 | Boston | Massachusetts | 02130-3446 | — |
| Boston Clinical Trials /ID# 231367 | Boston | Massachusetts | 02131-2515 | — |
| Michigan Headache & Neurological Institute (MHNI) /ID# 230659 | Ann Arbor | Michigan | 48104-5131 | — |
| Minneapolis Clinic of Neurology - Burnsville /ID# 231780 | Burnsville | Minnesota | 55337-6732 | — |
| StudyMetrix Research /ID# 230642 | City of Saint Peters | Missouri | 63303 | — |
| Clinvest Research LLC /ID# 252440 | Springfield | Missouri | 65807 | — |
| Excel Clinical Research /ID# 232188 | Las Vegas | Nevada | 89109 | — |
| Las Vegas Clinical Trials /ID# 232628 | North Las Vegas | Nevada | 89030-7187 | — |
| Albuquerque Clinical Trials, Inc. /ID# 231101 | Albuquerque | New Mexico | 87102 | — |
| Duplicate_Dent Neurosciences Research Center, Inc. /ID# 252442 | Amherst | New York | 14226 | — |
| Fieve Clinical Research, Inc. /ID# 231365 | New York | New York | 10017-1921 | — |
| Montefiore Headache Center /ID# 232130 | The Bronx | New York | 10461-2720 | — |
| Upstate Clinical Research Associates /ID# 231343 | Williamsville | New York | 14221-6046 | — |
| Headache Wellness Center /ID# 230819 | Greensboro | North Carolina | 27405 | — |
| M3 Wake Research Inc. /ID# 232285 | Raleigh | North Carolina | 27612-8106 | — |
| Neurology - Triad /ID# 231733 | Winston-Salem | North Carolina | 27103-6984 | — |
| Duplicate_Duplicate_University Of Cincinnati Medical Center /ID# 231739 | Cincinnati | Ohio | 45267-0585 | — |
| 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 | — |
| Abington Neurological Associates - Abington /ID# 231798 | Abington | Pennsylvania | 19001 | — |
| Lehigh Center for Clinical Research /ID# 231355 | Allentown | Pennsylvania | 18103 | — |
| Suburban Research Associates - Media /ID# 231354 | Media | Pennsylvania | 19063-1760 | — |
| Jefferson Hospital for Neuroscience /ID# 230664 | Philadelphia | Pennsylvania | 19107-5191 | — |
| Duplicate_Frontier Clinical Research /ID# 232623 | Smithfield | Pennsylvania | 15478 | — |
| Clinical Trials of SC /ID# 231369 | Charleston | South Carolina | 29406 | — |
| Coastal Carolina Research Center - North Charleston /ID# 231353 | North Charleston | South Carolina | 29405 | — |
| Clinical Neuroscience Solutions - Memphis /ID# 231328 | Memphis | Tennessee | 38119 | — |
| Nashville Neuroscience Group /ID# 231642 | Nashville | Tennessee | 37203 | — |
| Austin Clinical Trial Partners /ID# 231092 | Austin | Texas | 78737 | — |
| Texas Neurology /ID# 230661 | Dallas | Texas | 75214 | — |
| NeuroCare Plus /ID# 252499 | Houston | Texas | 77094-1385 | — |
| Charlottesville Medical Research /ID# 231368 | Charlottesville | Virginia | 22911 | — |
| Integrated Neurology Services - Falls Church /ID# 244776 | Falls Church | Virginia | 22043-2367 | — |
| Tidewater Integr Med Research /ID# 231359 | Virginia Beach | Virginia | 23451 | — |
| Sentara Neurology Specialists - Virginia Beach /ID# 231341 | Virginia Beach | Virginia | 23456-0019 | — |
| Northwest Clinical Research Center /ID# 231336 | Bellevue | Washington | 98007 | — |
| Puget Sound Neurology /ID# 230640 | Tacoma | Washington | 25328 | — |
| Frontier Clinical Research - Kingwood /ID# 234127 | Kingwood | West Virginia | 26537-9797 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 51 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05028569, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 9, 2025 · Synced Oct 31, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05028569 live on ClinicalTrials.gov.