Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine
Public ClinicalTrials.gov record NCT05216263. 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
A Phase 3 Multicenter 24-Week Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Atogepant When Added to OnabotulinumtoxinA (BOTOX) for the Preventive Treatment of Chronic Migraine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Migraine is characterized by attacks of throbbing, moderate or severe headache, often associated with nausea, vomiting, and/or sensitivity to light and/or sound. The study will assess safety and tolerability of atogepant when added to BOTOX, as well as prospectively evaluate the efficacy of add-on atogepant for migraine prevention. Adverse events and change in disease activity will be monitored. Atogepant is an investigational drug being developed to prevent chronic migraine. Approximately 75 adult participants will be enrolled at approximately 30 sites in the United States. All participants will receive atogepant oral tablet once a day (QD) during the 24-week treatment period, in addition to their standard of care Botox. 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
- NCT05216263
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 75 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 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
- Mar 22, 2022 (Actual)
- Primary completion
- May 2, 2025 (Actual)
- Completion
- May 2, 2025 (Actual)
- Last update posted
- Jun 16, 2026
2022 – 2025
United States locations
- U.S. sites
- 29
- U.S. states
- 18
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neurology and Neurodiagnostics of Alabama /ID# 242538 | Hoover | Alabama | 35244-5700 | — |
| Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 241812 | Phoenix | Arizona | 85013 | — |
| Arkansas Clinical Research /ID# 241789 | Little Rock | Arkansas | 72205 | — |
| Hope Clinical Research /ID# 241772 | Canoga Park | California | 91303 | — |
| Profound Research LLC /ID# 244084 | Carlsbad | California | 92011-4213 | — |
| Neuro Pain Medical Center /ID# 241992 | Fresno | California | 93710 | — |
| Neurological Research Institute /ID# 242688 | Santa Monica | California | 90404 | — |
| Neurology Offices of South Florida, PLLC /ID# 242693 | Boca Raton | Florida | 33428-2231 | — |
| Coastal Clinical Research Specialists /ID# 247992 | Jacksonville Beach | Florida | 32250-1694 | — |
| University of Miami /ID# 252230 | Miami | Florida | 33136 | — |
| First Physicians Group - Waldemere /ID# 242861 | Sarasota | Florida | 34239-2943 | — |
| Kansas Institute of Research /ID# 241796 | Overland Park | Kansas | 66211-1363 | — |
| Duplicate_Ochsner Clinic Foundation /ID# 241803 | Covington | Louisiana | 70433-8107 | — |
| Beth Israel Deaconess Medical Center /ID# 241800 | Boston | Massachusetts | 02215-5400 | — |
| Michigan Headache & Neurological Institute (MHNI) /ID# 241784 | Ann Arbor | Michigan | 48104-5131 | — |
| Minneapolis Clinic of Neurology - Burnsville /ID# 241994 | Burnsville | Minnesota | 55337-6732 | — |
| Albany Medical College /ID# 242757 | Albany | New York | 12208 | — |
| Dent Neurologic Institute - Amherst /ID# 241776 | Amherst | New York | 14226 | — |
| Headache Wellness Center /ID# 241791 | Greensboro | North Carolina | 27405 | — |
| Jefferson Hospital for Neuroscience /ID# 243712 | Philadelphia | Pennsylvania | 19107-5191 | — |
| Preferred Primary Care Physicians - Jacob Murphy /ID# 241798 | Uniontown | Pennsylvania | 15401 | — |
| Chattanooga Medical Research /ID# 253295 | Chattanooga | Tennessee | 37404-3239 | — |
| Nashville Neuroscience Group /ID# 243592 | Nashville | Tennessee | 37203 | — |
| Texas Neurology /ID# 241795 | Dallas | Texas | 75214 | — |
| Inova Health System /ID# 252242 | Falls Church | Virginia | 22042 | — |
| Integrated Neurology Services - Falls Church /ID# 244747 | Falls Church | Virginia | 22043-2367 | — |
| Puget Sound Neurology /ID# 241787 | Tacoma | Washington | 25328 | — |
| Frontier Clinical Research - Kingwood /ID# 242928 | Kingwood | West Virginia | 26537-9797 | — |
| West Virginia Univ School Med /ID# 252869 | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05216263, 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 Jun 16, 2026 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05216263 live on ClinicalTrials.gov.