Cincinnati, Ohio 45212

  • Episodic Migraine

Purpose:

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


Criteria:

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


NCT ID:

NCT04740827


Primary Contact:

Study Director
Dr. Joel Trugman
Allergan

Clinical Trials Registry Team
Phone: 877-277-8566
Email: IR-CTRegistration@Allergan.com


Backup Contact:

N/A


Location Contact:

Cincinnati, Ohio 45212
United States

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 27, 2021

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