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

Completed · Phase 3 · Has a placebo group

Conditions studied: Episodic Migraine

In brief

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.

Key facts

Study ID

NCT03777059

Run by

Allergan

People needed

910

Starts

2018-12-14

Expected to finish

2020-06-19

Last updated by the study team

2021-07-09

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Advanced Research Associates — Glendale, Arizona, United States
• Alea Research Institute — Phoenix, Arizona, United States
• Barrow Neurological Institute — 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
• Triwest Research Associates — El Cajon, California, United States
• Neuro Pain Medical Center — Fresno, California, United States
• California Headache and Balance Center — Fresno, California, United States
• Fullerton Neurology and Headache Center — Fullerton, California, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• NervePro Research Bruce Cleeremans — Irvine, California, United States
• Grossmont Center for Clinical Research — La Mesa, California, United States
• Torrance Clinical Research Institute, Inc. — Lomita, California, United States
• Long Beach Clinical Trials Services — Long Beach, California, United States
• Keck Medicine of USC — Los Angeles, 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
• Stanford — Palo Alto, California, United States
• Rancho Cucamonga Clinical Research — Rancho Cucamonga, California, United States
• Desert Valley Research — Redlands, California, United States
• Synexus Clinical Research US, Inc. — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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