An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine

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

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

Study Overview

• Status: Completed
• Conditions: Migraine, With or Without Aura
• Intervention / Treatment: Drug: Ubrogepant; Drug: Usual Care; Drug: Placebo-matching Ubrogepant

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.

• Study Type: Interventional
• Enrollment (Actual): 1254
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Radiant Research, Inc.
  • Arizona
    • Chandler, Arizona, United States, 85224
      • East Family Physicians PC/Radiant Research, Inc.
    • Mesa, Arizona, United States, 85213
      • Desert Clinical Research /Radiant Research, Inc.
    • Phoenix, Arizona, United States, 85004
      • Xenoscience, Inc.
    • Phoenix, Arizona, United States, 85020
      • Central Phoenix Medical Clinic
    • Tucson, Arizona, United States, 85712
      • Radiant Research Inc.
    • Tucson, Arizona, United States, 85741
      • Orange Grove Family Practice/Radiant Research, Inc.
  • Arkansas
    • Hot Springs, Arkansas, United States, 71901
      • Principals Research Group, Inc.
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Clinical Research
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Apple Valley, California, United States, 92307
      • Axiom Research
    • Canoga Park, California, United States, 91303
      • HOPE Clinical Research
    • Carmichael, California, United States, 95608
      • Med Center Medical Clinic Carmichael
    • Colton, California, United States, 92324
      • Axiom Research, LLC
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • Encino, California, United States, 91436
      • Encino Research Center/T Joseph Raoof MD Inc
    • Fresno, California, United States, 93710
      • Neuro-Pain Medical Center, Inc
    • Fresno, California, United States, 93720
      • California Headache and Balance Center
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • Glendale, California, United States, 91206
      • Behavioral Research Specialists, LLC
    • Imperial, California, United States, 92251
      • Sun Valley Research Center
    • La Mesa, California, United States, 91942
      • Grossmont Center for Clinical Research
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, LLC
    • Los Alamitos, California, United States, 90270
      • Pharmacology Research Institute
    • Los Angeles, California, United States, 90024
      • Pacific Institute of Medical Research
    • National City, California, United States, 91950
      • Synergy San Diego
    • Newport Beach, California, United States, 92663
      • Newport Beach Clinical Research Associates, Inc.
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute
    • Rancho Cucamonga, California, United States, 91730
      • Rancho Cucamonga Clinical Research
    • Rancho Mirage, California, United States, 92270
      • Desert Valley Research
    • Redondo Beach, California, United States, 90277
      • George J Rederich MD, Inc.
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • Santa Monica, California, United States, 90404
      • California Medical Clinic for Headache
    • Simi Valley, California, United States, 93065
      • Southern California Research Center
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
    • Vista, California, United States, 92083
      • Radiant Research
  • Colorado
    • Boulder, Colorado, United States, 80301
      • Alpine Clinical Research Center
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Neurological Associates
    • Colorado Springs, Colorado, United States, 80918
      • Delta Waves, INC
    • Colorado Springs, Colorado, United States, 80904
      • Clinicos LLC
    • Denver, Colorado, United States, 80210
      • Denver Neurological Research
    • Englewood, Colorado, United States, 80113
      • Summit Headache and Neurologic Institute
    • Fort Collins, Colorado, United States, 80528
      • Advanced Neurosciences Research
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Associated Neurologists, PC
    • Fairfield, Connecticut, United States, 06824
      • Associated Neurologists of Southern Connecticut, PC
  • Florida
    • Aventura, Florida, United States, 33180
      • Aventura Neurological Associates, PA
    • Coral Gables, Florida, United States, 33134
      • Clinical Research South Florida
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Hallandale Beach, Florida, United States, 33009
      • Wilks & Safirstein MD PA D/B/A MD Clinical
    • Hollywood, Florida, United States, 33021
      • Infinity Clinical Research
    • Hollywood, Florida, United States, 33024
      • Broward Research
    • Jacksonville, Florida, United States, 32256
      • Clinical NeuroScience Solutions Inc
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc.
    • Maitland, Florida, United States, 32751
      • Neurology Associates, P.A.
    • Miami, Florida, United States, 33143
      • Well Pharma Medical Research
    • Miami, Florida, United States, 33126
      • LCC Medical Research
    • Miami Lakes, Florida, United States, 33014
      • Panax Clinical Research
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Ocoee, Florida, United States, 34761
      • Sensible Healthcare, LLC
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc - Memphis, TN
    • Palm Beach Gardens, Florida, United States, 33410
      • Palm Beach Neurological Center / Advanced Research Consultants, Inc.
    • South Miami, Florida, United States, 33143
      • Qps Mra, Llc
    • Spring Hill, Florida, United States, 34609
      • Meridien Research
    • Tampa, Florida, United States, 33612
      • University of South Florida
    • Tampa, Florida, United States, 33634
      • Meridien Research
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
    • West Palm Beach, Florida, United States, 33407
      • Neurology Research Institute Palm Beach
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • NeuroTrials Research Inc
    • Atlanta, Georgia, United States, 30312
      • Midtown Neurology
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar Crosse Research Center
    • Chicago, Illinois, United States, 60604
      • Michigan Ave. Internists /Radiant Research, Inc.
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials, LLC
    • Riverwoods, Illinois, United States, 60015
      • Robbins Headache Clinic
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic Inc.
    • Indianapolis, Indiana, United States, 46256
      • Josephson Wallack Munshower Neurology, P.C.
  • Kansas
    • Lenexa, Kansas, United States, 66214
      • Rowe Neurology Institute
    • Overland Park, Kansas, United States, 66211
      • Kansas Institute of Research
    • Overland Park, Kansas, United States, 66210
      • College Park Family Care Center Physicians Group- Neurology Research Dept
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatric Research Inc
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
    • Louisville, Kentucky, United States, 40207
      • Norton Neurology Services
  • Maryland
    • Baltimore, Maryland, United States, 21228
      • Seton Medical Group
    • Baltimore, Maryland, United States, 21208
      • Pharma Site Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials Inc
    • New Bedford, Massachusetts, United States, 02470
      • Btc of New Bedford
    • North Dartmouth, Massachusetts, United States, 02747
      • Northeast Medical Research Associates, Inc.
    • Quincy, Massachusetts, United States, 02169
      • Beacon Clinical Research, LLC
    • Watertown, Massachusetts, United States, 02472
      • MedVadis Research Corporation
    • Worcester, Massachusetts, United States, 01605
      • New England Regional Headache Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head Pain & Neurological Institute
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
    • Kalamazoo, Michigan, United States, 49009
      • Women's Health Care Specialists
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • The Minneapolis Clinic of Neurology, Ltd.
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute, Inc.
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Olive Branch Family Medical Center
    • Ridgeland, Mississippi, United States, 39157
      • The Headache Center
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest
  • Nebraska
    • Fremont, Nebraska, United States, 68025
      • Prairie Fields Family Medicine
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research
    • Omaha, Nebraska, United States, 68114
      • Clinical Research Advantage, Inc/Synexus USA
  • Nevada
    • Las Vegas, Nevada, United States, 89117
      • Diagnostic Center of Medicine - Durango / Radiant Research, Inc.
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Princeton Medical Institute
    • Skillman, New Jersey, United States, 08558
      • Princeton Center for Clinical Research
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Neuroscience, Inc.
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center
    • Endwell, New York, United States, 13760
      • Regional Clinical Research, Inc.
    • Manlius, New York, United States, 13104
      • Central New York Clinical Research
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates
  • North Carolina
    • Greensboro, North Carolina, United States, 27405
      • Headache Wellness Center
    • Hickory, North Carolina, United States, 28602
      • Neurology Associates, P.A.
    • Mooresville, North Carolina, United States, 28117
      • Lake Shore Clinical Research, LLC
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates Llc
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Plains Clinical Research Center, LLC
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research, Inc.
    • Canton, Ohio, United States, 44718
      • Neuro-Behavioral Clinical Research, Inc
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45227
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45215
      • Patient Priority Clinical Sites
    • Cincinnati, Ohio, United States, 45212
      • Sentral Clinical Research Services
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research, Inc
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research, Inc.
    • Cleveland, Ohio, United States, 44124
      • Ohio Clinical Research, LLC
    • Columbus, Ohio, United States, 43213
      • Aventiv Research Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73109
      • NPC Research
    • Oklahoma City, Oklahoma, United States, 73112
      • Sooner Clinical Research Inc
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network Inc.
    • Portland, Oregon, United States, 97214
      • Oregon Center for Clinical Investigations Inc
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians, Inc.
    • Uniontown, Pennsylvania, United States, 15401
      • Preferred Primary Care Physicians
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Lincoln Research
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
    • Columbia, South Carolina, United States, 29201
      • Vista Clinical Research
    • Simpsonville, South Carolina, United States, 29681
      • Hillcrest Clinical Research LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch, LLC
    • Fayetteville, Tennessee, United States, 37334
      • Middle Tennessee Clinical Research
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group, P.C.
    • Knoxville, Tennessee, United States, 37920
      • New Orleans Center for Clinical Research
    • Memphis, Tennessee, United States, 38119
      • CNS Healthcare
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research
    • Austin, Texas, United States, 78731
      • Future Search Trials
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, LP
    • Dallas, Texas, United States, 75214
      • Texas Neurology, P.A.
    • Dallas, Texas, United States, 75234
      • Radiant Research, Inc.
    • Humble, Texas, United States, 77338
      • Research Trials Worldwide, LLC
    • Lake Jackson, Texas, United States, 77566
      • Red Star Research, LLC
    • San Antonio, Texas, United States, 78258
      • Road Runner Research
    • San Antonio, Texas, United States, 78229
      • Clinical Trials Texas, Inc
  • Utah
    • Draper, Utah, United States, 84020
      • J. Lewis Research, Inc. / Foothill Family Clinic Draper
    • Ogden, Utah, United States, 84403
      • Advanced Research Institute
    • Riverton, Utah, United States, 84065
      • Granger Medical Clinic - Riverton
    • Salt Lake City, Utah, United States, 84102
      • Optimum Clinical Research, Inc.
    • Salt Lake City, Utah, United States, 84124
      • Highland Clinical Reserach
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research Center, LLC
    • Norfolk, Virginia, United States, 23507
      • Clinical Research Associates Tidewater
    • Roanoke, Virginia, United States, 24018
      • Blue Ridge Research Center
    • Virginia Beach, Virginia, United States, 23454
      • Tidewater Integrated Medical Research
    • Virginia Beach, Virginia, United States, 23456
      • Sentara Neurology Specialists
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Seattle, Washington, United States, 98104
      • The Polyclinic
    • Tacoma, Washington, United States, 98409
      • South Puget Sound Neurology
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.	Drug: Usual Care; Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.
Experimental: Ubrogepant 50 mg; Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.	Drug: Ubrogepant; Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.; Drug: Placebo-matching Ubrogepant; Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.
Experimental: Ubrogepant 100 mg; Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.	Drug: Ubrogepant; Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.	56 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinically Significant Laboratory Values	Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.	56 Weeks
Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings	ECG findings considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.	56 Weeks
Number of Participants With Clinically Significant Vital Sign Measurements	Vital sign measurements considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.	56 Weeks
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales	On the C-SSRS, the 5 types of suicidal ideation are: Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"	56 Weeks

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Adele Thorpe, Allergan

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• More Information

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2016
• Primary Completion (Actual): August 2, 2018
• Study Completion (Actual): August 2, 2018

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 23, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: UBR-MD-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No