Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Allergan
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine
