Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine

Completed · Phase 3

Conditions studied: Episodic Migraine

In brief

This study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.

Key facts

Study ID

NCT03700320

Run by

Allergan

People needed

744

Starts

2018-10-08

Expected to finish

2020-05-21

Last updated by the study team

2021-06-15

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 (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
• Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC migraine prevention medications and the participant is willing to accept SOC treatment.
• Participants must be using a medically acceptable and effective method of birth control during the course of the entire study,
• 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
• History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1

You may not qualify if…

• Difficulty distinguishing migraine headaches from tension-type or other headaches
• Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
• Has a current diagnosis of chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy
• ≥ 15 headache days per month on average across the 3 months prior to Visit 1
• Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well
• 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
• Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (GI), or neurologic disease
• Hypertension as defined by sitting systolic blood pressure (BP) > 160 millimeter of mercury (mm Hg) or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once.
• At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence
• History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.

Where it is running

• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• Synexus Clinical Research US, Inc./East Valley Family Physicians PLC — Chandler, Arizona, United States
• Synexus Clinical Research US, Inc./Desert Clinical Research, LLC — Mesa, Arizona, United States
• Synexus Clinical Research US, Inc./Central Phoenix Medical Clinic, LLC — Phoenix, Arizona, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Hope Clinical Research — Canoga Park, California, United States
• Pharmacology Research Institute — Encino, California, United States
• Sun Valley Research Center, Inc. — Imperial, California, United States
• Irvine Center for Clinical Research — Irvine, California, United States
• Grossmont Center for Clinical Research — La Mesa, California, United States
• Synergy San Diego — Lemon Grove, California, United States
• Collaborative Neuroscience Network, LLC. — Long Beach, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Pacific Research Partners, LLC — Oakland, California, United States
• Excell Research, Inc. — Oceanside, California, United States
• Desert Valley Research — Redlands, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• California Research Foundation — San Diego, California, United States
• Artemis Institute for Clinical Research — San Marcos, California, United States
• California Medical Clinic for Headache — Santa Monica, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Synexus Clinical Research US, Inc. — Vista, California, United States
• Diablo Clinical Research, Inc — Walnut Creek, California, United States
• Delta Waves, Inc. — Colorado Springs, Colorado, United States
• Clinical Research Advantage, Inc./Simon Williamson Clinic, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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