Status:
COMPLETED
A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine
Lead Sponsor:
AbbVie
Conditions:
Episodic Migraine
Chronic Migraine
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine
Eligibility Criteria
Inclusion
- \- Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.
Exclusion
- Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative.
- Participants with an ECG indicating clinically significant abnormalities at Visit 1.
- Participants with hypertension at Visit 1.
- Participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.
- Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Key Trial Info
Start Date :
February 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2025
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT04686136
Start Date
February 19 2021
End Date
October 20 2025
Last Update
December 18 2025
Active Locations (116)
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1
Duplicate_Barrow Neurological Institute /ID# 228217
Phoenix, Arizona, United States, 85013-4407
2
California Headache and Balance Center /ID# 226241
Fresno, California, United States, 93720
3
Duplicate_Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404
Los Alamitos, California, United States, 90720-3500
4
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389
Newport Beach, California, United States, 92660