Status:
COMPLETED
12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine
Lead Sponsor:
Allergan
Conditions:
Episodic Migraine
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2020
Estimated Enrollment :
910 Patients enrolled
Trial Details
Trial ID
NCT03777059
Start Date
December 14 2018
End Date
June 19 2020
Last Update
July 9 2021
Active Locations (138)
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1
Synexus Clinical Research US, Inc.
Chandler, Arizona, United States, 85224
2
Advanced Research Associates
Glendale, Arizona, United States, 85308
3
Alea Research Institute
Phoenix, Arizona, United States, 85012
4
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013