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An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Multicenter, Randomized, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura

NCT02873221•Allergan

View on ClinicalTrials.gov

Summary

This study will evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year.

Detailed Description

Usual care is the open-label control arm. Dose of ubrogepant (50 mg or 100 mg) will be double-blind for active treatment arms.

Eligibility

Age

18 - 76 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709).

Exclusion Criteria

•Patients with clinically significant electrocardiogram (ECG), vital sign, physical exam, or laboratory abnormalities
•Requirement for a medication during the study that is on the list of prohibited medications.

Locations (177)

Radiant Research, Inc.

Birmingham, Alabama, United States

East Family Physicians PC/Radiant Research, Inc.

Chandler, Arizona, United States

Desert Clinical Research /Radiant Research, Inc.

Mesa, Arizona, United States

Xenoscience, Inc.

Phoenix, Arizona, United States

Central Phoenix Medical Clinic

Phoenix, Arizona, United States

Radiant Research Inc.

Tucson, Arizona, United States

Orange Grove Family Practice/Radiant Research, Inc.

Tucson, Arizona, United States

Principals Research Group, Inc.

Hot Springs, Arkansas, United States

Arkansas Clinical Research

Little Rock, Arkansas, United States

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Key Dates

Start Date

September 13, 2016

Primary Completion Date

August 2, 2018

Completion Date

August 2, 2018

Last Updated

August 28, 2019

Enrollment

1,254

ACTUAL participants

Conditions

Migraine, With or Without Aura

Interventions

Ubrogepant

DRUG

Placebo-matching Ubrogepant

DRUG

Usual Care

DRUG

Safety and Efficacy in Adult Subjects With Acute Migraines

NCT03237845

Migraine, With or Without Aura

View study

COMPLETEDPHASE3

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

NCT02867709

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: August 28, 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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