A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine

Completed · Phase 3

Conditions studied: Episodic Migraine, Chronic Migraine

In brief

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

Key facts

Study ID

NCT04686136

Run by

AbbVie

People needed

596

Starts

2021-02-19

Expected to finish

2025-10-20

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• California Headache and Balance Center /ID# 226241 — Fresno, California, United States
• Duplicate_Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404 — Los Alamitos, California, United States
• Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389 — Newport Beach, California, United States
• Excell Research, Inc /ID# 228390 — Oceanside, California, United States
• Duplicate_Schuster Medical Research Institute /ID# 226246 — Sherman Oaks, California, United States
• Alpine Clinical Research Center /ID# 226203 — Boulder, Colorado, United States
• Sensible Healthcare /ID# 226426 — Ocoee, Florida, United States
• Accel Research Sites - Tampa Clinical Research Unit /ID# 226252 — Tampa, Florida, United States
• NeuroTrials Research Inc /ID# 226477 — Atlanta, Georgia, United States
• Allied Physicians - Fort Wayne Neurological Center /ID# 226390 — Fort Wayne, Indiana, United States
• Josephson-Wallack-Munshower Neurology - Northeast /ID# 226295 — Indianapolis, Indiana, United States
• Collective Medical Research /ID# 226482 — Overland Park, Kansas, United States
• Ochsner Clinic Foundation /ID# 228220 — Covington, Louisiana, United States
• Pharmasite Research, Inc. /ID# 226444 — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center /ID# 228214 — Boston, Massachusetts, United States
• BTC of New Bedford /ID# 226289 — New Bedford, Massachusetts, United States
• Clinical Research Institute, Inc /ID# 226232 — Minneapolis, Minnesota, United States
• Headache Neurology Research Institute /ID# 226234 — Ridgeland, Mississippi, United States
• StudyMetrix Research /ID# 226296 — City of Saint Peters, Missouri, United States
• Clinvest Research LLC /ID# 226275 — Springfield, Missouri, United States
• Methodist Physicians Clinic/CCT Research /ID# 226422 — Fremont, Nebraska, United States
• Albuquerque Clinical Trials, Inc. /ID# 226523 — Albuquerque, New Mexico, United States
• Albany Medical Center Rheumatology /ID# 228212 — Albany, New York, United States
• Headache Wellness Center /ID# 226233 — Greensboro, North Carolina, United States
• Duplicate_Barrow Neurological Institute /ID# 228217 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.