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

COMPLETEDPHASE2/PHASE3

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

A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Dosing Regimens Of Oral AGN-241689 In Episodic Migraine Prevention

NCT02848326•Allergan

View on ClinicalTrials.gov

Summary

This study will evaluate the safety and tolerability of the following doses of atogepant (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has at least a 1-year history of migraine with or without aura
•Age of the patient at the time of migraine onset \< 50 years
•History of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to Visit 1 in the Investigator's judgment
•Demonstrated compliance with e-diary

Exclusion Criteria

•Has a history of migraine accompanied by diplopia or decreased level of consciousness and retinal migraine
•Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
•Difficulty distinguishing migraine headache from other headaches
•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 gastric or small intestinal surgery, or has a disease that causes malabsorption
•Has a history of hepatitis within previous 6 months
•Usage of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs \[NSAIDs\], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1
•Pregnant or nursing females

Locations (75)

Achieve Clinical Research

Birmingham, Alabama, United States

Radiant Research, Inc.

Chandler, Arizona, United States

The Research Center of Southern California, LLC

Carlsbad, California, United States

Neuro-Pain Medical Center, Inc

Fresno, California, United States

Irvine Center for Clinical Research

Irvine, California, United States

Downtown LA Research Center, Inc.

Los Angeles, California, United States

Excell Research

Oceanside, California, United States

Artemis Institute for Clinical Research

San Marcos, California, United States

Diablo Clinical Research Inc

Walnut Creek, California, United States

Advanced Neurosciences Research

Fort Collins, Colorado, United States

Key Dates

Start Date

September 6, 2016

Primary Completion Date

April 2, 2018

Completion Date

April 23, 2018

Last Updated

December 6, 2018

Enrollment

834

ACTUAL participants

Conditions

Migraine, With or Without Aura

Interventions

Atogepant

DRUG

Placebo-matching Atogepant

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

COMPLETEDPHASE3

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

NCT02867709

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: December 6, 2018Data 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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