Clinical trial NCT02848326: Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Migraine, With or Without Aura
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-07-28
Enrollment: 834
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period
timeFrame: Baseline (First 28 Days of Screening/Baseline Period) to Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period
timeFrame: Baseline (First 28 Days of Screening/Baseline Period) to Week 12
measure: 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
timeFrame: Baseline (First 28 Days of Screening/Baseline Period) to Week 12
measure: Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period
timeFrame: Baseline (First 28 Days of Screening/Baseline Period) to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research
state: Alabama
city: Chandler
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Carlsbad
country: United States
facility: The Research Center of Southern California, LLC
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center, Inc
state: California
city: Irvine
country: United States
facility: Irvine Center for Clinical Research
state: California
city: Los Angeles
country: United States
facility: Downtown LA Research Center, Inc.
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: San Marcos
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research Inc
state: California
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research
state: Colorado
city: East Hartford
country: United States
facility: Hartford Headache Center
state: Connecticut
city: Fairfield
country: United States
facility: Associated Neurologists of Southern Connecticut, P. C.
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Washington
country: United States
facility: The George Washington University
state: District of Columbia
city: Coral Gables
country: United States
facility: Clinical Research South Florida
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Maitland
country: United States
facility: Meridien Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Neurological Center / Advanced Research Consultants, Inc.
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Neuroscience Associates, Inc.
state: Florida
city: Sunrise
country: United States
facility: Infinity Clinical Research LLC
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: West Palm Beach
country: United States
facility: Neurology Research Institute Palm Beach
state: Florida
city: Alpharetta
country: United States
facility: Institute for Advanced Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Radiant Research
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Sandy Springs
country: United States
facility: Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials, Inc.
state: Idaho
city: Blue Island
country: United States
facility: Healthcare Research Network II, LLC
state: Illinois
city: Lenexa
country: United States
facility: Rowe Neurology Institute
state: Kansas
city: Boston
country: United States
facility: Boston Clinical Trials Inc
state: Massachusetts
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc.
state: Massachusetts
city: Watertown
country: United States
facility: Medvadis Research Corporation
state: Massachusetts
city: Worcester
country: United States
facility: New England Regional Headache Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Springfield
country: United States
facility: Mercy Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research, Inc
state: Nebraska
city: Las Vegas
country: United States
facility: Altea Research Institute
state: Nevada
city: Reno
country: United States
facility: Renown Institute for Neuroscience
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute - NJ
state: New Jersey
city: Warren
country: United States
facility: Amici Clinical Research
state: New Jersey
city: Amherst
country: United States
facility: DENT Neurosciences Research Center
state: New York
city: Jamaica
country: United States
facility: Radiant Research, Inc.
state: New York
city: Durham
country: United States
facility: Carolina Headache Institute
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates LLC
state: North Carolina
city: Willoughby Hills
country: United States
facility: Ohio Clinical Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center For Clinical Research
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Memphis
country: United States
facility: Cns Healthcare
state: Tennessee
city: Nashville
country: United States
facility: Nashville Neuroscience Group
state: Tennessee
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Austin
country: United States
facility: DermResearch Inc
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Inc.
state: Texas
city: Dallas
country: United States
facility: Synexus US, L.P. Formally known as Texas Pharmaceutical Research, LP, DBA Research Across America
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology Consultant
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, San Antonio Center for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research LTD
state: Texas
city: Waxahachie
country: United States
facility: ClinPoint Trials, LLC
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Women's Clinical Research Center
state: Washington
city: Spokane
country: United States
facility: Kingfisher Cooperative, LLC
state: Washington
Study officials:
affiliation: Allergan
name: Joel Trugman, MD
role: STUDY_DIRECTOR
References:
citation: Goadsby 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.