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

  • End date
    Jun 21, 2022
  • participants needed
  • sponsor
Updated on 19 September 2021


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.

Condition Episodic Migraine
Treatment Placebo, Atogepant 60 mg
Clinical Study IdentifierNCT04740827
Last Modified on19 September 2021


Yes No Not Sure

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
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
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