Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine

Completed · Phase 4

Conditions studied: Episodic Migraine

In brief

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.

Key facts

Study ID

NCT05264129

Run by

AbbVie

People needed

263

Starts

2022-03-07

Expected to finish

2023-04-04

Last updated by the study team

2024-10-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD)-3, 2018.
• History of 4 to 14 migraine days per month on average in the 3 months prior to Screening (Visit 1) in the investigator's judgment.

You may not qualify if…

• Clinically significant hematologic, endocrine, cardiovascular, cerebrovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Where it is running

• Achieve Clinical Research, LLC /ID# 244912 — Birmingham, Alabama, United States
• Xenoscience, Inc /ID# 243506 — Phoenix, Arizona, United States
• Excell Research, Inc /ID# 242590 — Oceanside, California, United States
• Neurological Research Institute /ID# 244161 — Santa Monica, California, United States
• George J. Rederich M.D. Inc. /ID# 242589 — Torrance, California, United States
• Diablo Clinical Research /ID# 242592 — Walnut Creek, California, United States
• Westside Center for Clinical Research /ID# 243287 — Jacksonville, Florida, United States
• Suncoast Clinical Research /ID# 242463 — New Port Richey, Florida, United States
• Meridien Research /ID# 243508 — Orlando, Florida, United States
• Accel Research Sites - St Petersburg Clinical Research Unit /ID# 243091 — St. Petersburg, Florida, United States
• Meridian Clinical Research (Neurology) - Savannah /ID# 242689 — Savannah, Georgia, United States
• Clinical Research Atlanta - Headlands LLC /ID# 242661 — Stockbridge, Georgia, United States
• Allied Physicians - Fort Wayne Neurological Center /ID# 243511 — Fort Wayne, Indiana, United States
• Pharmasite Research, Inc. /ID# 243505 — Baltimore, Maryland, United States
• Medstar Georgetown Neurology /ID# 243289 — Chevy Chase, Maryland, United States
• QUEST Research Institute /ID# 243284 — Farmington Hills, Michigan, United States
• Clinvest Research LLC /ID# 242597 — Springfield, Missouri, United States
• Princeton Center for Clinical Research /ID# 242652 — Skillman, New Jersey, United States
• Bio Behavioral Health, Inc /ID# 242643 — Toms River, New Jersey, United States
• Dent Neurosciences Research Center, Inc. /ID# 242641 — Amherst, New York, United States
• Central New York Clinical Research /ID# 242593 — Manlius, New York, United States
• Rochester Clinical Research /ID# 242470 — New York, New York, United States
• PMG Research of Raleigh LLC /ID# 243286 — Raleigh, North Carolina, United States
• CTI Clinical Trial and Consulting /ID# 242884 — Cincinnati, Ohio, United States
• Aventiv Research Columbus /ID# 242462 — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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