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Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

NCT02867709•Allergan

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition, beta version
•Migraine onset before age 50
•History of migraines typically lasting 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 pain in each of the previous 3 months.

Exclusion Criteria

•Difficulty distinguishing migraine headache from tension-type other headaches
•Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs \[NSAIDs\], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months
•Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine
•Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
•Required hospital treatment of a migraine attack 3 or more times in the previous 6 months
•Has a chronic non-headache pain condition requiring daily pain medication
•Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
•Has a history of any prior gastrointestinal conditions (eg, diarrhoea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded
•Has a history of hepatitis within previous 6 months.

Locations (109)

Clinical Research Advantage, Inc./Simon Williamson Clinic

Birmingham, Alabama, United States

Clinical Research Advantage, Inc./East Valley Family Physicians, PLC

Chandler, Arizona, United States

St. Joseph's Hospital & Medical Center - Barrow Neurologic Institute (BNI)

Phoenix, Arizona, United States

Clinical Research Advantage, Inc./Central Phoenix Medical Clinic, LLC

Phoenix, Arizona, United States

Mayo Clinic Arizona, May Clinic Scottsdale

Scottsdale, Arizona, United States

Radiant Research Inc.

Tucson, Arizona, United States

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Axiom Research, LLC

Apple Valley, California, United States

Hope Clinical Research

Canoga Park, California, United States

Axiom Research, LLC

Colton, California, United States

Key Dates

Start Date

August 26, 2016

Primary Completion Date

January 25, 2018

Completion Date

February 26, 2018

Last Updated

March 19, 2019

Enrollment

1,686

ACTUAL participants

Conditions

Migraine, With or Without Aura

Interventions

Ubrogepant

DRUG

Placebo-matching Ubrogepant

DRUG

Safety and Efficacy in Adult Subjects With Acute Migraines

NCT03237845

Migraine, With or Without Aura

View study

COMPLETEDPHASE3

An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine

NCT02873221

Migraine, With or Without Aura

View study

COMPLETEDPHASE2/PHASE3

Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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