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Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments. | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Participants With Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic Treatments (ELEVATE)

NCT04740827•Allergan

View on ClinicalTrials.gov

Summary

This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.

Eligibility

Age

18 - 80 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 ICHD-3, 2018.
•Age of the participant at the time of migraine onset \< 50 years -History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment
•Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
•4 to 14 migraine days in the 28-day baseline period per eDiary
•Failed oral migraine prophylaxis medications from 2 to 4 medication classes

Exclusion Criteria

•Any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal, or neurologic disease
•Participant has any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder
•In the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine
•Has ≥ 15 headache days per month on average across the 3 months prior to Visit 1 in the investigator's judgment
•Has ≥ 15 headache days in the 28-day baseline period per eDiary
•Clinically significant cardiovascular or cerebrovascular disease
•Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018
•Has a current diagnosis of chronic migraine, new persistent daily headache, medication overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018

Locations (114)

Axiom Research /ID# 226379

Colton, California, United States

Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 226434

Encino, California, United States

Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226388

Los Alamitos, California, United States

Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226405

Los Alamitos, California, United States

Excell Research, Inc /ID# 228386

Oceanside, California, United States

Alpine Clinical Research Center /ID# 226201

Boulder, Colorado, United States

Sensible Healthcare /ID# 226197

Ocoee, Florida, United States

Meridien Research /ID# 226224

St. Petersburg, Florida, United States

Meridien Research /ID# 226302

St. Petersburg, Florida, United States

Velocity Clinical Research - Boise /ID# 226320

Meridian, Idaho, United States

Key Dates

Start Date

March 5, 2021

Primary Completion Date

August 4, 2022

Completion Date

August 4, 2022

Last Updated

September 21, 2023

Enrollment

315

ACTUAL participants

Conditions

Episodic Migraine

Interventions

Atogepant 60 mg

DRUG

Placebo

DRUG

Prophylactic Treatment With Atorvastatin for Episodic Migraine.

NCT06248671

Episodic Migraine

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ACTIVE_NOT_RECRUITINGPHASE3

A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine

NCT03432286

Episodic Migraine

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COMPLETEDPHASE4

Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention

NCT05207865

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: September 21, 2023Data 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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Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.

Inclusion Criteria

Exclusion Criteria

Prophylactic Treatment With Atorvastatin for Episodic Migraine.

A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine

Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention

Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)

HD-EEG Connectivity Changes in Migraine Patients Undergoing Treatment With Anti-CGRP mAbs

Transnasal Cooling for Migraine