Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine
Public ClinicalTrials.gov record NCT05264129. 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 4, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of the Concomitant Use of Ubrogepant for the Acute Treatment of Migraine in Subjects Taking Atogepant for the Preventive Treatment of 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. This study will assess the safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine headache in participants taking atogepant once daily for preventive treatment of migraine. Ubrogepant is an approved drug for the acute treatment of migraine. Atogepant is an approved drug for the preventive treatment of migraine. Approximately 235 adult participants with EM will be enrolled in approximately 45 sites in the United States. Participants will receive oral atogepant tablets once daily (QD) for 12 weeks followed by continued atogepant treatment with ubrogepant tablets taken as needed for the next 12 weeks. 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
- NCT05264129
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 263 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 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 6, 2022
- Primary completion
- Apr 3, 2023
- Completion
- Apr 3, 2023
- Last update posted
- Oct 7, 2024
2022 – 2023
United States locations
- U.S. sites
- 37
- U.S. states
- 19
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Achieve Clinical Research, LLC /ID# 244912 | Birmingham | Alabama | 35216 | — |
| Xenoscience, Inc /ID# 243506 | Phoenix | Arizona | 85004 | — |
| Excell Research, Inc /ID# 242590 | Oceanside | California | 92056 | — |
| Neurological Research Institute /ID# 244161 | Santa Monica | California | 90404 | — |
| George J. Rederich M.D. Inc. /ID# 242589 | Torrance | California | 90505 | — |
| Diablo Clinical Research /ID# 242592 | Walnut Creek | California | 94598 | — |
| Westside Center for Clinical Research /ID# 243287 | Jacksonville | Florida | 32205-4785 | — |
| Suncoast Clinical Research /ID# 242463 | New Port Richey | Florida | 34652 | — |
| Meridien Research /ID# 243508 | Orlando | Florida | 32810 | — |
| Accel Research Sites - St Petersburg Clinical Research Unit /ID# 243091 | St. Petersburg | Florida | 33709-3113 | — |
| Meridian Clinical Research (Neurology) - Savannah /ID# 242689 | Savannah | Georgia | 31406-2758 | — |
| Clinical Research Atlanta - Headlands LLC /ID# 242661 | Stockbridge | Georgia | 30281-9054 | — |
| Allied Physicians - Fort Wayne Neurological Center /ID# 243511 | Fort Wayne | Indiana | 46804 | — |
| Pharmasite Research, Inc. /ID# 243505 | Baltimore | Maryland | 21208 | — |
| Medstar Georgetown Neurology /ID# 243289 | Chevy Chase | Maryland | 20815 | — |
| QUEST Research Institute /ID# 243284 | Farmington Hills | Michigan | 48334-2977 | — |
| Clinvest Research LLC /ID# 242597 | Springfield | Missouri | 65807 | — |
| Princeton Center for Clinical Research /ID# 242652 | Skillman | New Jersey | 08558 | — |
| Bio Behavioral Health, Inc /ID# 242643 | Toms River | New Jersey | 08755-6434 | — |
| Dent Neurosciences Research Center, Inc. /ID# 242641 | Amherst | New York | 14226 | — |
| Central New York Clinical Research /ID# 242593 | Manlius | New York | 13104 | — |
| Rochester Clinical Research /ID# 242470 | New York | New York | 14609 | — |
| PMG Research of Raleigh LLC /ID# 243286 | Raleigh | North Carolina | 27609 | — |
| CTI Clinical Trial and Consulting /ID# 242884 | Cincinnati | Ohio | 45212 | — |
| Aventiv Research Columbus /ID# 242462 | Columbus | Ohio | 43213 | — |
| The Orthopedic Foundation /ID# 243292 | New Albany | Ohio | 43054-8167 | — |
| Summit Research Network /ID# 242467 | Portland | Oregon | 97210 | — |
| Abington Neurological Associates - Abington /ID# 243291 | Abington | Pennsylvania | 19001 | — |
| WR-ClinSearch /ID# 242640 | Chattanooga | Tennessee | 37421-1605 | — |
| FutureSearch Trials of Neurology /ID# 242690 | Austin | Texas | 78731 | — |
| DiscoveResearch, Inc /ID# 242469 | Bryan | Texas | 77802 | — |
| FutureSearch Trials of Dallas, LP /ID# 242658 | Dallas | Texas | 75231 | — |
| Protenium Clinical Research /ID# 244067 | Hurst | Texas | 76054 | — |
| ClinPoint Trials /ID# 242660 | Waxahachie | Texas | 75165-1430 | — |
| Advanced Research Institute - Ridgeline /ID# 242662 | Ogden | Utah | 84405-6779 | — |
| Highland Clinical Research /ID# 245159 | Salt Lake City | Utah | 84124 | — |
| Core Clinical Research /ID# 244436 | Everett | Washington | 98201 | — |
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 NCT05264129, 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 Oct 7, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05264129 live on ClinicalTrials.gov.