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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
834
Atogepant capsule.
Placebo-matching atogepant capsule.
Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4- week period and multiplied by 28. Each 4-week period was averaged. Negative change from Baseline indicates improvement.
Time frame: Baseline (First 28 Days of Screening/Baseline Period) to Week 12
Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period
Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration and acute symptomatic medication use. The 4-week (monthly) headache days was defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Negative change from Baseline indicates improvement.
Time frame: Baseline (First 28 Days of Screening/Baseline Period) to Week 12
Percentage of Participants With at Least a 50% Reduction in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days=total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. Each 4-week period was averaged.
Time frame: Baseline (First 28 Days of Screening/Baseline Period) to Week 12
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Achieve Clinical Research
Birmingham, Alabama, United States
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
...and 65 more locations
Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The 4-week (monthly) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. A negative change from Baseline indicates improvement.
Time frame: Baseline (First 28 Days of Screening/Baseline Period) to Week 12