Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention
A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Dosing Regimens Of Oral AGN-241689 In Episodic Migraine Prevention
1 other identifier
interventional
834
1 country
75
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2016
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2016
CompletedFirst Posted
Study publicly available on registry
July 28, 2016
CompletedStudy Start
First participant enrolled
September 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2018
CompletedResults Posted
Study results publicly available
December 6, 2018
CompletedDecember 6, 2018
November 1, 2018
1.6 years
July 26, 2016
November 13, 2018
November 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline (First 28 Days of Screening/Baseline Period) to Week 12
Secondary Outcomes (3)
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
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
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
Study Arms (6)
Placebo
PLACEBO COMPARATORPlacebo-matching atogepant capsule orally twice daily in the morning and in the evening for 12 weeks.
Atogepant 10 mg QD
EXPERIMENTALAtogepant 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
EXPERIMENTALAtogepant 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 30 mg BID
EXPERIMENTALAtogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Atogepant 60 mg QD
EXPERIMENTALAtogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
Atogepant 60 mg BID
EXPERIMENTALAtogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Interventions
Atogepant capsule.
Placebo-matching atogepant capsule.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (75)
Achieve Clinical Research
Birmingham, Alabama, 35216, United States
Radiant Research, Inc.
Chandler, Arizona, 85224, United States
The Research Center of Southern California, LLC
Carlsbad, California, 92011, United States
Neuro-Pain Medical Center, Inc
Fresno, California, 93710, United States
Irvine Center for Clinical Research
Irvine, California, 92618, United States
Downtown LA Research Center, Inc.
Los Angeles, California, 90017, United States
Excell Research
Oceanside, California, 92056, United States
Artemis Institute for Clinical Research
San Marcos, California, 92078, United States
Diablo Clinical Research Inc
Walnut Creek, California, 94598, United States
Advanced Neurosciences Research
Fort Collins, Colorado, 80528, United States
Hartford Headache Center
East Hartford, Connecticut, 06118, United States
Associated Neurologists of Southern Connecticut, P. C.
Fairfield, Connecticut, 06824, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
The George Washington University
Washington D.C., District of Columbia, 20037, United States
Clinical Research South Florida
Coral Gables, Florida, 33134, United States
Infinity Clinical Research
Hollywood, Florida, 33021, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32256, United States
Meridien Research
Maitland, Florida, 32751, United States
Suncoast Research
Miami, Florida, 33135, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Clinical Neuroscience Solutions
Orlando, Florida, 32801, United States
Palm Beach Neurological Center / Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, 33410, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33713, United States
Infinity Clinical Research LLC
Sunrise, Florida, 33351, United States
Meridien Research
Tampa, Florida, 33634, United States
Neurology Research Institute Palm Beach
West Palm Beach, Florida, 33407, United States
Institute for Advanced Medical Research
Alpharetta, Georgia, 30005, United States
Radiant Research
Atlanta, Georgia, 30328, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
iResearch Atlanta, LLC
Decatur, Georgia, 30030, United States
Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology
Sandy Springs, Georgia, 30328, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Northwest Clinical Trials, Inc.
Boise, Idaho, 83704, United States
Healthcare Research Network II, LLC
Blue Island, Illinois, 60406, United States
Rowe Neurology Institute
Lenexa, Kansas, 66214, United States
Boston Clinical Trials Inc
Boston, Massachusetts, 02131, United States
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747, United States
Medvadis Research Corporation
Watertown, Massachusetts, 02472, United States
New England Regional Headache Center
Worcester, Massachusetts, 01605, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402, United States
Mercy Research
Springfield, Missouri, 65806, United States
Clinvest
Springfield, Missouri, 65807, United States
Quality Clinical Research, Inc
Omaha, Nebraska, 68114, United States
Altea Research Institute
Las Vegas, Nevada, 89102, United States
Renown Institute for Neuroscience
Reno, Nevada, 89502, United States
Hassman Research Institute - NJ
Berlin, New Jersey, 08009, United States
Amici Clinical Research
Warren Township, New Jersey, 07059, United States
DENT Neurosciences Research Center
Amherst, New York, 14226, United States
Radiant Research, Inc.
Jamaica, New York, 11432, United States
Carolina Headache Institute
Durham, North Carolina, 27713, United States
Wake Research Associates LLC
Raleigh, North Carolina, 27612, United States
Ohio Clinical Research, LLC
Willoughby Hills, Ohio, 44094, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, 97301, United States
Lehigh Center For Clinical Research
Allentown, Pennsylvania, 18104, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Cns Healthcare
Memphis, Tennessee, 38119, United States
Nashville Neuroscience Group
Nashville, Tennessee, 37203, United States
Tekton Research
Austin, Texas, 78745, United States
DermResearch Inc
Austin, Texas, 78759, United States
DiscoveResearch, Inc.
Bryan, Texas, 77802, United States
Synexus US, L.P. Formally known as Texas Pharmaceutical Research, LP, DBA Research Across America
Dallas, Texas, 75234, United States
Central Texas Neurology Consultant
Round Rock, Texas, 78681, United States
Radiant Research, San Antonio Center for Clinical Research
San Antonio, Texas, 78229, United States
Road Runner Research LTD
San Antonio, Texas, 78258, United States
ClinPoint Trials, LLC
Waxahachie, Texas, 75165, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Women's Clinical Research Center
Seattle, Washington, 98105, United States
Kingfisher Cooperative, LLC
Spokane, Washington, 99202, United States
Related Publications (4)
Goadsby PJ, Jurgens TP, Brand-Schieber E, Nagy K, Liu Y, Boinpally R, Stodtmann S, Trugman JM. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials. Cephalalgia. 2025 Feb;45(2):3331024251320610. doi: 10.1177/03331024251320610.
PMID: 39982105DERIVEDPeterlin BL, Bond DS, Ailani J, Dodick DW, Liu Y, De Abreu Ferreira R, Smith JH, Dabruzzo B, Goadsby PJ, Trugman JM. Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis. Cephalalgia. 2024 Dec;44(12):3331024241299753. doi: 10.1177/03331024241299753.
PMID: 39648629DERIVEDRizzoli P, Marmura MJ, Robblee J, McVige J, Sacco S, Nahas SJ, Ailani J, De Abreu Ferreira R, Ma J, Smith JH, Dabruzzo B, Ashina M. Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials. J Headache Pain. 2024 Mar 11;25(1):35. doi: 10.1186/s10194-024-01736-z.
PMID: 38462625DERIVEDGoadsby PJ, Dodick DW, Ailani J, Trugman JM, Finnegan M, Lu K, Szegedi A. Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. Lancet Neurol. 2020 Sep;19(9):727-737. doi: 10.1016/S1474-4422(20)30234-9.
PMID: 32822633DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Joel Trugman, MD
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2016
First Posted
July 28, 2016
Study Start
September 6, 2016
Primary Completion
April 2, 2018
Study Completion
April 23, 2018
Last Updated
December 6, 2018
Results First Posted
December 6, 2018
Record last verified: 2018-11