Newport Beach, California 92660

  • Migraine

Purpose:

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


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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, 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


NCT ID:

NCT04492020


Primary Contact:

Study Director
Joel Trugman
Allergan

Clinical Trial Registry Team
Phone: 877-277-8566
Email: IR-CTRegistration@allergan.com


Backup Contact:

N/A


Location Contact:

Newport Beach, California 92660
United States

Study Coordinator
Phone: 949-752-7910

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 28, 2021

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