A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

• Status: Enrolling by invitation
• Trial end date: 2022-10-10
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Japanese Participants with Chronic or Episodic Migraine

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

Details

• Lead Sponsor: Allergan

Criteria

Inclusion Criteria:

• Eligible participants who completed the double-blind treatment period of Study 3101-303-002 or Study 3101-305-002 without significant protocol deviations and who did not experience an AE that, in the investigator's opinion, may indicate an unacceptable safety risk;

• Participants must be using a medically acceptable and effective method of birth control during the course of the entire study

Exclusion Criteria:

• Requirement for any medication, diet, or nonpharmacological treatment that is on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative medication or treatment;

• Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1;

• Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Visit 1;

• Significant risk of self-harm based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator;

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