Clinical trial NCT02873221: An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine
Official title: A Multicenter, Randomized, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine, With or Without Aura
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-08-19
Enrollment: 1254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year.

Detailed description: Usual care is the open-label control arm. Dose of ubrogepant (50 mg or 100 mg) will be double-blind for active treatment arms.

Eligibility criteria: Inclusion Criteria:

-Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709).

Exclusion Criteria:

* Patients with clinically significant electrocardiogram (ECG), vital sign, physical exam, or laboratory abnormalities
* Requirement for a medication during the study that is on the list of prohibited medications.

Primary outcomes:
measure: Percentage of Participants With at Least 1 Treatment Emergent Adverse Event
timeFrame: 56 Weeks
Secondary outcomes:
measure: Number of Participants With Clinically Significant Laboratory Values
timeFrame: 56 Weeks
measure: Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings
timeFrame: 56 Weeks
measure: Number of Participants With Clinically Significant Vital Sign Measurements
timeFrame: 56 Weeks
measure: Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales
timeFrame: 56 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research, Inc.
state: Alabama
city: Chandler
country: United States
facility: East Family Physicians PC/Radiant Research, Inc.
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Research /Radiant Research, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Xenoscience, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic
state: Arizona
city: Tucson
country: United States
facility: Radiant Research Inc.
state: Arizona
city: Tucson
country: United States
facility: Orange Grove Family Practice/Radiant Research, Inc.
state: Arizona
city: Hot Springs
country: United States
facility: Principals Research Group, Inc.
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Clinical Research
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Apple Valley
country: United States
facility: Axiom Research
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Carmichael
country: United States
facility: Med Center Medical Clinic Carmichael
state: California
city: Colton
country: United States
facility: Axiom Research, LLC
state: California
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Encino
country: United States
facility: Encino Research Center/T Joseph Raoof MD Inc
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center, Inc
state: California
city: Fresno
country: United States
facility: California Headache and Balance Center
state: California
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: La Mesa
country: United States
facility: Grossmont Center For Clinical Research
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: Los Angeles
country: United States
facility: Pacific Institute of Medical Research
state: California
city: National City
country: United States
facility: Synergy San Diego
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Newport Beach Clinical Research Associates, Inc.
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga Clinical Research
state: California
city: Rancho Mirage
country: United States
facility: Desert Valley Research
state: California
city: Redondo Beach
country: United States
facility: George J Rederich MD, Inc.
state: California
city: San Diego
country: United States
facility: Artemis Institute For Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
city: Simi Valley
country: United States
facility: Southern California Research Center
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Vista
country: United States
facility: Radiant Research
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Colorado Springs
country: United States
facility: Clinicos LLC
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Colorado Springs
country: United States
facility: Delta Waves, Inc
state: Colorado
city: Denver
country: United States
facility: Denver Neurological Research
state: Colorado
city: Englewood
country: United States
facility: Summit Headache and Neurologic Institute
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research
state: Colorado
city: Danbury
country: United States
facility: Associated Neurologists, PC
state: Connecticut
city: Fairfield
country: United States
facility: Associated Neurologists of Southern Connecticut, PC
state: Connecticut
city: Aventura
country: United States
facility: Aventura Neurological Associates, PA
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research South Florida
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hallandale Beach
country: United States
facility: Wilks & Safirstein MD PA D/B/A MD Clinical
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research
state: Florida
city: Hollywood
country: United States
facility: Broward Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Maitland
country: United States
facility: Neurology Associates, P.A.
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami
country: United States
facility: LCC Medical Research
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc - Memphis, TN
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Neurological Center / Advanced Research Consultants, Inc.
state: Florida
city: South Miami
country: United States
facility: Qps Mra, Llc
state: Florida
city: Spring Hill
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida
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: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Midtown Neurology
state: Georgia
city: Atlanta
country: United States
facility: NeuroTrials Research Inc
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Michigan Ave. Internists /Radiant Research, Inc.
state: Illinois
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Chicago
country: United States
facility: Great Lakes Clinical Trials, LLC
state: Illinois
city: Riverwoods
country: United States
facility: Robbins Headache Clinic
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Inc.
state: Indiana
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology, P.C.
state: Indiana
city: Lenexa
country: United States
facility: Rowe Neurology Institute
state: Kansas
city: Overland Park
country: United States
facility: College Park Family Care Center Physicians Group- Neurology Research Dept
state: Kansas
city: Overland Park
country: United States
facility: Kansas Institute of Research
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric Research Inc
state: Kentucky
city: Louisville
country: United States
facility: Norton Neurology Services
state: Kentucky
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Baltimore
country: United States
facility: Pharma Site Research
state: Maryland
city: Baltimore
country: United States
facility: Seton Medical Group
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials Inc
state: Massachusetts
city: New Bedford
country: United States
facility: BTC of New Bedford
state: Massachusetts
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc.
state: Massachusetts
city: Quincy
country: United States
facility: Beacon Clinical Research, LLC
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 & Neurological Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Kalamazoo
country: United States
facility: Women's Health Care Specialists
state: Michigan
city: Golden Valley
country: United States
facility: The Minneapolis Clinic of Neurology, Ltd.
state: Minnesota
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: Ridgeland
country: United States
facility: The Headache Center
state: Mississippi
city: Springfield
country: United States
facility: Clinvest
state: Missouri
city: Fremont
country: United States
facility: Prairie Fields Family Medicine
state: Nebraska
city: Omaha
country: United States
facility: Clinical Research Advantage, Inc/Synexus USA
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Diagnostic Center of Medicine - Durango / Radiant Research, Inc.
state: Nevada
city: Princeton
country: United States
facility: Princeton Medical Institute
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: Albuquerque
country: United States
facility: Albuquerque Neuroscience, 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: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center
state: North Carolina
city: Hickory
country: United States
facility: Neurology Associates, P.A.
state: North Carolina
city: Mooresville
country: United States
facility: Lake Shore Clinical Research, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Fargo
country: United States
facility: Plains Clinical Research Center, LLC
state: North Dakota
city: Akron
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Sentral Clinical Research Services
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites
state: Ohio
city: Cincinnati
country: United States
facility: University of cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical research Center
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research, Inc
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Ohio Clinical Research, LLC
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: NPC Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research Inc
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network Inc.
state: Oregon
city: Portland
country: United States
facility: Oregon Center For Clinical Investigations Inc
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc.
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research
state: South Carolina
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Vista Clinical Research
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research LLC
state: South Carolina
city: Chattanooga
country: United States
facility: Clinsearch, LLC
state: Tennessee
city: Fayetteville
country: United States
facility: Middle Tennessee Clinical Research
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group, P.C.
state: Tennessee
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
city: Memphis
country: United States
facility: CNS Healthcare
state: Tennessee
city: Austin
country: United States
facility: Future Search Trials
state: Texas
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Dallas
country: United States
facility: Texas Neurology, P.A.
state: Texas
city: Dallas
country: United States
facility: Futuresearch Trials of Dallas, LP
state: Texas
city: Dallas
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Humble
country: United States
facility: Research Trials Worldwide, LLC
state: Texas
city: Lake Jackson
country: United States
facility: Red Star Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials Texas, Inc
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research
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: Riverton
country: United States
facility: Granger Medical Clinic - Riverton
state: Utah
city: Salt Lake City
country: United States
facility: Optimum Clinical Research, Inc.
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Reserach
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates Tidewater
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Research Center
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Neurology Specialists
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: The Polyclinic
state: Washington
city: Tacoma
country: United States
facility: South Puget Sound Neurology
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Allergan
name: Adele Thorpe
role: STUDY_DIRECTOR
References:
citation: Lipton RB, Dodick DW, Goadsby PJ, Burstein R, Adams AM, Lai J, Yu SY, Finnegan M, Kuang AW, Trugman JM. Efficacy of Ubrogepant in the Acute Treatment of Migraine With Mild Pain vs Moderate or Severe Pain. Neurology. 2022 Oct 25;99(17):e1905-e1915. doi: 10.1212/WNL.0000000000201031. Epub 2022 Aug 17.
citation: Blumenfeld AM, Knievel K, Manack Adams A, Severt L, Butler M, Lai H, Dodick DW. Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials. Adv Ther. 2022 Jan;39(1):692-705. doi: 10.1007/s12325-021-01923-3. Epub 2021 Dec 7.