12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine

• Status: Completed
• Trial end date: 2020-06-19
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the prevention of migraine in participants with episodic migraine.

• 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.

• Age of the participant at the time of migraine onset <50 years.

Exclusion Criteria:

• Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine.

• Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy.

• History of an inadequate response to >4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine.

• Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.