Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine

In brief

Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome

Key facts

Study ID

NCT04492020

Run by

AbbVie

People needed

518

Starts

2020-08-21

Expected to finish

2022-04-19

Last updated by the study team

2023-05-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3 (International Classification of Headache Disorders 3rd edition)
• Migraine onset before age 50 years
• By history, the participant's migraines typically last between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
• History of 2 to 8 migraine attacks per month with moderate to severe headache in each of the 3 months prior to the Screening Visit

You may not qualify if…

• Difficulty distinguishing migraine headache from tension-type or other headaches
• Participants who overuse medication for migraine defined as use of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment
• Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3
• A current diagnosis of chronic migraine as defined by ICHD-3 or a history of 15 or more headache days per month on average in the 6 months prior to Visit 1 in the investigator's judgment. A headache day is defined as a day in which there was any occurrence of a headache of a minimum duration of 2 hours or a headache of any duration for which acute medication was taken
• Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3
• Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to Visit 1
• History of malignancy in the 5 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
• History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that, per investigator judgment, may affect the absorption or metabolism of the study intervention; participants with prior gastric bariatric interventions (eg, Lap Band) which have been reversed are not excluded

Where it is running

• Barrow Neuro Institute /ID# 236775 — Phoenix, Arizona, United States
• Arkansas Clinical Research /ID# 238032 — Little Rock, Arkansas, United States
• California Headache and Balance Center /ID# 236247 — Fresno, California, United States
• Sun Valley Research Center /ID# 236561 — Imperial, California, United States
• Wr-Pri Llc /Id# 236007 — Los Alamitos, California, United States
• Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237691 — Newport Beach, California, United States
• Excell Research, Inc /ID# 237721 — Oceanside, California, United States
• George J. Rederich M.D. Inc. /ID# 235769 — Torrance, California, United States
• Diablo Clinical Research /ID# 237570 — Walnut Creek, California, United States
• Colorado Springs Neurological Associates (CSNA) /ID# 236556 — Colorado Springs, Colorado, United States
• Advanced Neurosciences Research, LLC /ID# 237426 — Fort Collins, Colorado, United States
• CNS Healthcare - Jacksonville /ID# 238245 — Jacksonville, Florida, United States
• Health Awareness, Inc - Jupiter /ID# 236226 — Jupiter, Florida, United States
• Suncoast Clinical Research /ID# 236934 — New Port Richey, Florida, United States
• Sensible Healthcare /ID# 238090 — Ocoee, Florida, United States
• Clinical Neuroscience Solutions, Inc /ID# 236608 — Orlando, Florida, United States
• Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237163 — St. Petersburg, Florida, United States
• University of South Florida /ID# 234387 — Tampa, Florida, United States
• ForCare Clinical Research /ID# 237092 — Tampa, Florida, United States
• Premiere Research Institute - Palm Beach /ID# 238193 — West Palm Beach, Florida, United States
• NeuroTrials Research Inc. /ID# 237365 — Atlanta, Georgia, United States
• iResearch Atlanta, LLC /ID# 237390 — Decatur, Georgia, United States
• Meridian Clinical Research (Neurology) - Savannah /ID# 234371 — Savannah, Georgia, United States
• Clinical Research Atlanta - Headlands LLC /ID# 234438 — Stockbridge, Georgia, United States
• Achieve Clinical Research, LLC /ID# 237098 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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