Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention
- Conditions
- Migraine, With or Without Aura
- Interventions
- Registration Number
- NCT02848326
- Lead Sponsor
- Allergan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 834
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atogepant 60 mg BID Atogepant Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks. Atogepant 30 mg BID Atogepant Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks. Placebo Placebo-matching Atogepant Placebo-matching atogepant capsule orally twice daily in the morning and in the evening for 12 weeks. Atogepant 60 mg QD Placebo-matching Atogepant Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks. Atogepant 30 mg QD Placebo-matching Atogepant Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks. Atogepant 10 mg QD Placebo-matching Atogepant Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks. Atogepant 60 mg QD Atogepant Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks. Atogepant 10 mg QD Atogepant Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks. Atogepant 30 mg QD Atogepant Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period Baseline (First 28 Days of Screening/Baseline Period) to Week 12 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period Baseline (First 28 Days of Screening/Baseline Period) to Week 12 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.
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 Baseline (First 28 Days of Screening/Baseline Period) to Week 12 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.
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period Baseline (First 28 Days of Screening/Baseline Period) to Week 12 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.
Trial Locations
- Locations (73)
Central Texas Neurology Consultant
🇺🇸Round Rock, Texas, United States
Irvine Center for Clinical Research
🇺🇸Irvine, California, United States
iResearch Atlanta, LLC
🇺🇸Decatur, Georgia, United States
New England Regional Headache Center
🇺🇸Worcester, Massachusetts, United States
Advanced Clinical Research
🇺🇸West Jordan, Utah, United States
Wake Research Associates LLC
🇺🇸Raleigh, North Carolina, United States
Synexus US, L.P. Formally known as Texas Pharmaceutical Research, LP, DBA Research Across America
🇺🇸Dallas, Texas, United States
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Boston Clinical Trials Inc
🇺🇸Boston, Massachusetts, United States
Suncoast Research
🇺🇸Miami, Florida, United States
Altea Research Institute
🇺🇸Las Vegas, Nevada, United States
Women's Clinical Research Center
🇺🇸Seattle, Washington, United States
Rowe Neurology Institute
🇺🇸Lenexa, Kansas, United States
Clinical Research Institute, Inc.
🇺🇸Minneapolis, Minnesota, United States
Carolina Headache Institute
🇺🇸Durham, North Carolina, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Nashville Neuroscience Group
🇺🇸Nashville, Tennessee, United States
Radiant Research, San Antonio Center for Clinical Research
🇺🇸San Antonio, Texas, United States
Road Runner Research LTD
🇺🇸San Antonio, Texas, United States
Neuro-Pain Medical Center, Inc
🇺🇸Fresno, California, United States
Infinity Clinical Research
🇺🇸Hollywood, Florida, United States
Achieve Clinical Research
🇺🇸Birmingham, Alabama, United States
Quality Clinical Research, Inc
🇺🇸Omaha, Nebraska, United States
Radiant Research, Inc.
🇺🇸Jamaica, New York, United States
The Research Center of Southern California, LLC
🇺🇸Carlsbad, California, United States
Downtown LA Research Center, Inc.
🇺🇸Los Angeles, 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
Clinical Research South Florida
🇺🇸Coral Gables, Florida, United States
Associated Neurologists of Southern Connecticut, P. C.
🇺🇸Fairfield, Connecticut, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Clinical Neuroscience Solutions Inc
🇺🇸Jacksonville, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Infinity Clinical Research LLC
🇺🇸Sunrise, Florida, United States
Suncoast Neuroscience Associates, Inc.
🇺🇸Saint Petersburg, Florida, United States
Neurology Research Institute Palm Beach
🇺🇸West Palm Beach, Florida, United States
Institute for Advanced Medical Research
🇺🇸Alpharetta, Georgia, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Healthcare Research Network II, LLC
🇺🇸Blue Island, Illinois, United States
Northeast Medical Research Associates, Inc.
🇺🇸North Dartmouth, Massachusetts, United States
Medvadis Research Corporation
🇺🇸Watertown, Massachusetts, United States
Mercy Research
🇺🇸Springfield, Missouri, United States
Hassman Research Institute - NJ
🇺🇸Berlin, New Jersey, United States
DENT Neurosciences Research Center
🇺🇸Amherst, New York, United States
Amici Clinical Research
🇺🇸Warren, New Jersey, United States
Ohio Clinical Research, LLC
🇺🇸Willoughby Hills, Ohio, United States
Lehigh Center For Clinical Research
🇺🇸Allentown, Pennsylvania, United States
ClinPoint Trials, LLC
🇺🇸Waxahachie, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Kingfisher Cooperative, LLC
🇺🇸Spokane, Washington, United States
Hartford Headache Center
🇺🇸East Hartford, Connecticut, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Excell Research
🇺🇸Oceanside, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Palm Beach Neurological Center / Advanced Research Consultants, Inc.
🇺🇸Palm Beach Gardens, Florida, United States
Clinvest
🇺🇸Springfield, Missouri, United States
Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology
🇺🇸Sandy Springs, Georgia, United States
Cns Healthcare
🇺🇸Memphis, Tennessee, United States
Northwest Clinical Trials, Inc.
🇺🇸Boise, Idaho, United States
Renown Institute for Neuroscience
🇺🇸Reno, Nevada, United States
DiscoveResearch, Inc.
🇺🇸Bryan, Texas, United States
Oregon Center for Clinical Investigations, Inc.
🇺🇸Salem, Oregon, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Clinical Neuroscience Solutions
🇺🇸Orlando, Florida, United States
Michigan Head Pain and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Tekton Research
🇺🇸Austin, Texas, United States
DermResearch Inc
🇺🇸Austin, Texas, United States
The George Washington University
🇺🇸Washington, District of Columbia, United States
Radiant Research
🇺🇸Atlanta, Georgia, United States