Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine

Completed · Phase 3

Conditions studied: Episodic Migraine

In brief

The purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once a day for the prevention of migraine in participants with episodic migraine.

Key facts

Study ID

NCT03939312

Run by

Allergan

People needed

685

Starts

2019-05-06

Expected to finish

2021-03-31

Last updated by the study team

2022-05-12

Who can join

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

You may qualify if…

• Written informed consent and participant privacy information (eg, written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
• Participants must be using a medically acceptable and effective method of birth control during the course of the entire study.
• Eligible participants who completed the double-blind treatment period (Visit 7) and the follow-up period (Visit 8), if applicable, depending on the timing of study initiation, of Study 3101-301-002 (NCT03777059) without significant protocol deviations (eg, noncompliance to protocol-required procedures).

You may not qualify if…

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

Where it is running

• Alea Research — Phoenix, Arizona, United States
• Central Phoenix Medical Clinic — Phoenix, Arizona, United States
• Orange Grove Family Practice — Tucson, Arizona, United States
• Principals Research Group — Hot Springs, Arkansas, United States
• Arkansas Clinical Research — Little Rock, Arkansas, United States
• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• Med Center Medical Clinic — Carmichael, California, United States
• Neuro Pain Medical Center — Fresno, California, United States
• California Headache and Balance Center — Fresno, California, United States
• Grossmont Center for Clinical Research — La Mesa, California, United States
• Paradigm Clinical Research Centers, Inc — La Mesa, California, United States
• Torrance Clinical Research Institute, Inc. — Lomita, California, United States
• Long Beach Clinical Trials Services — Long Beach, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Newport Beach Clinical Research Associates — Newport Beach, California, United States
• Excell Research, Inc. — Oceanside, California, United States
• Rancho Cucamonga Clinical Trials — Rancho Cucamonga, California, United States
• Desert Valley Research — Redlands, California, United States
• George J. Rederich, M.D. Inc. — Redondo Beach, California, United States
• Optimus Medical Group — San Francisco, California, United States
• California Neuroscience Research — Sherman Oaks, California, United States
• Alpine Clinical Research Center — Boulder, Colorado, United States
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
• Colorado Neurological Institute — Englewood, Colorado, United States
• Synexus Clinical Research US, Inc. — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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