Clinical trial NCT03700320: Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine
Official title: A Phase 3, Multicenter, Randomized, Open-label Study to Evaluate the Long-term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Episodic Migraine
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 744
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.


Eligibility criteria: Inclusion Criteria:

* Written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
* Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC migraine prevention medications and the participant is willing to accept SOC treatment.
* Participants must be using a medically acceptable and effective method of birth control during the course of the entire study,
* 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
* History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1

Exclusion Criteria:

* Difficulty distinguishing migraine headaches from tension-type or other headaches
* Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
* Has a current diagnosis of chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy
* ≥ 15 headache days per month on average across the 3 months prior to Visit 1
* Usage of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well
* Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test
* Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (GI), or neurologic disease
* Hypertension as defined by sitting systolic blood pressure (BP) \> 160 millimeter of mercury (mm Hg) or sitting diastolic BP \> 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once.
* At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence
* History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.

Primary outcomes:
measure: Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)
timeFrame: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
Secondary outcomes:
measure: Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator
timeFrame: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
measure: Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator
timeFrame: Up to Week 52
measure: Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator
timeFrame: From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up)
measure: Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Advantage, Inc./Simon Williamson Clinic, PC
state: Alabama
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Chandler
country: United States
facility: Synexus Clinical Research US, Inc./East Valley Family Physicians PLC
state: Arizona
city: Mesa
country: United States
facility: Synexus Clinical Research US, Inc./Desert Clinical Research, LLC
state: Arizona
city: Phoenix
country: United States
facility: Synexus Clinical Research US, Inc./Central Phoenix Medical Clinic, LLC
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center, Inc.
state: California
city: Irvine
country: United States
facility: Irvine Center for Clinical Research
state: California
city: La Mesa
country: United States
facility: Grossmont Center for Clinical Research
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC.
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Oakland
country: United States
facility: Pacific Research Partners, LLC
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Redlands
country: United States
facility: Desert Valley Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: San Marcos
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Vista
country: United States
facility: Synexus Clinical Research US, Inc.
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc
state: California
city: Colorado Springs
country: United States
facility: Delta Waves, Inc.
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research, LLC
state: Colorado
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Maitland
country: United States
facility: Meridien Research
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research, Corp.
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Orlando
country: United States
facility: Bioclinica Research
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: Premiere Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Synexus Clinical Research US, Inc.
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Clinical Research
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Evanston
country: United States
facility: Evanston Premier Healthcare Research LLC
state: Illinois
city: Lenexa
country: United States
facility: MidAmerica Neuroscience Research Foundation dba Rowe Neurology Institute
state: Kansas
city: Overland Park
country: United States
facility: Kansas Institute of Research
state: Kansas
city: Prairie Village
country: United States
facility: Phoenix Medical Research, Inc.
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric Research
state: Kentucky
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Marlborough
country: United States
facility: Community Clinical Research Network
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Headache & Neurological Institute
state: Michigan
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Springfield
country: United States
facility: ClinVest
state: Missouri
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Synexus Clinical Research US, Inc
state: Nebraska
city: Las Vegas
country: United States
facility: Altea Research Institute
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institutes
state: New Jersey
city: Raritan
country: United States
facility: Amici Clinical Research
state: New Jersey
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Jamaica
country: United States
facility: Synexus Clinical Research US, Inc.
state: New York
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates, LLC
state: New York
city: Fargo
country: United States
facility: Plains Clinical Medical Clinic, LLC
state: North Dakota
city: Akron
country: United States
facility: Synexus Clinical Research US, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Synexus Clinical Research US, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
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: Portland
country: United States
facility: Summit Research Network
state: Oregon
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: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Scottdale
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Anderson
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research, LLC
state: South Dakota
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Memphis
country: United States
facility: CNS Healthcare - Memphis
state: Tennessee
city: Tullahoma
country: United States
facility: Trinity Clinical Research
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Austin
country: United States
facility: Tekton Research, Inc
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Inc.
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Houston
country: United States
facility: Earle Research
state: Texas
city: Humble
country: United States
facility: Research Trials WorldWide, LLC
state: Texas
city: San Antonio
country: United States
facility: Synexus Clinical Research US, Inc.
state: Texas
city: Waxahachie
country: United States
facility: ClinPoint Trials
state: Texas
city: Draper
country: United States
facility: J. Lewis Research, Inc./Foothill Family Clinic Draper
state: Utah
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
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: Seattle Women's: Health, Research
state: Washington
city: Madison
country: United States
facility: SSM Dean Health Research
state: Wisconsin
Study officials:
affiliation: Allergan
name: Joel Trugman, MD
role: STUDY_DIRECTOR
References:
citation: Boinpally R, McNamee B, Yao L, Butler M, McGeeney D, Borbridge L, Periclou A. A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1099-1107. doi: 10.1002/cpdd.940. Epub 2021 May 4.
citation: Min KC, Kraft WK, Bondiskey P, Colon-Gonzalez F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24.