Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Migraine, With or Without Aura

In brief

This study will evaluate the safety and tolerability of the following doses of atogepant (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship.

Key facts

Study ID

NCT02848326

Run by

Allergan

People needed

834

Starts

2016-09-06

Expected to finish

2018-04-23

Last updated by the study team

2018-12-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has at least a 1-year history of migraine with or without aura
• Age of the patient at the time of migraine onset < 50 years
• History of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to Visit 1 in the Investigator's judgment
• Demonstrated compliance with e-diary

You may not qualify if…

• Has a history of migraine accompanied by diplopia or decreased level of consciousness and retinal migraine
• Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
• Difficulty distinguishing migraine headache from other headaches
• Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
• Has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption
• Has a history of hepatitis within previous 6 months
• Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1
• Pregnant or nursing females

Where it is running

• Radiant Research, Inc. — Chandler, Arizona, United States
• The Research Center of Southern California, LLC — Carlsbad, California, United States
• Neuro-Pain Medical Center, Inc — Fresno, California, United States
• Irvine Center for Clinical Research — Irvine, California, United States
• Downtown LA Research Center, Inc. — Los Angeles, California, United States
• Excell Research — Oceanside, California, United States
• Artemis Institute for Clinical Research — San Marcos, California, United States
• Diablo Clinical Research Inc — Walnut Creek, California, United States
• Advanced Neurosciences Research — Fort Collins, Colorado, United States
• Hartford Headache Center — East Hartford, Connecticut, United States
• Associated Neurologists of Southern Connecticut, P. C. — Fairfield, Connecticut, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• The George Washington University — Washington D.C., District of Columbia, United States
• Clinical Research South Florida — Coral Gables, Florida, United States
• Infinity Clinical Research — Hollywood, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions Inc — Jacksonville, Florida, United States
• Meridien Research — Maitland, Florida, United States
• Suncoast Research — Miami, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Clinical Neuroscience Solutions — Orlando, Florida, United States
• Palm Beach Neurological Center / Advanced Research Consultants, Inc. — Palm Beach Gardens, Florida, United States
• Suncoast Neuroscience Associates, Inc. — St. Petersburg, Florida, United States
• Infinity Clinical Research LLC — Sunrise, Florida, United States
• Achieve Clinical Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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