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

• Status: Recruiting
• Trial end date: 2022-06-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan

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