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Migraine, With or Without AuraPhase 3NCT02873221

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

A Phase 3 study testing Ubrogepant in people with Migraine, With or Without Aura, run by Allergan at 177 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 76 years
Conditions the study is for
Migraine, With or Without Aura
What is being tested?
Ubrogepant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,254 participants
Where
177 sitesUnited States
Study dates
13 Sep 2016to 2 Aug 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 76 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

177 sites in 1 country.

177 sites in 1 country

United States177 sites

  • Radiant Research, Inc.

    Akron, Ohio, 44311

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Albuquerque Neuroscience, Inc.

    Albuquerque, New Mexico, 87109

  • DENT Neurosciences Research Center

    Amherst, New York, 14226

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Radiant Research

    Anderson, South Carolina, 29621

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan, 48104

  • Axiom Research

    Apple Valley, California, 92307

  • Midtown Neurology

    Atlanta, Georgia, 30312

  • NeuroTrials Research Inc

    Atlanta, Georgia, 30342

  • Future Search Trials

    Austin, Texas, 78731

  • Tekton Research

    Austin, Texas, 78745

  • Aventura Neurological Associates, PA

    Aventura, Florida, 33180

  • Pharma Site Research

    Baltimore, Maryland, 21208

  • Seton Medical Group

    Baltimore, Maryland, 21228

  • Kentucky Pediatric Research Inc

    Bardstown, Kentucky, 40004

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Radiant Research, Inc.

    Birmingham, Alabama, 35211

  • Boston Clinical Trials Inc

    Boston, Massachusetts, 02131

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Neuro-Behavioral Clinical Research, Inc

    Canton, Ohio, 44718

  • Med Center Medical Clinic Carmichael

    Carmichael, California, 95608

  • East Family Physicians PC/Radiant Research, Inc.

    Chandler, Arizona, 85224

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia, 22911

  • Clinsearch, LLC

    Chattanooga, Tennessee, 37421

  • Michigan Ave. Internists /Radiant Research, Inc.

    Chicago, Illinois, 60604

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • Great Lakes Clinical Trials, LLC

    Chicago, Illinois, 60640

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • Sentral Clinical Research Services

    Cincinnati, Ohio, 45212

  • Patient Priority Clinical Sites

    Cincinnati, Ohio, 45215

  • University of cincinnati

    Cincinnati, Ohio, 45219

  • CTI Clinical research Center

    Cincinnati, Ohio, 45227

  • Radiant Research, Inc

    Cincinnati, Ohio, 45249

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Ohio Clinical Research, LLC

    Cleveland, Ohio, 44124

  • Clinicos LLC

    Colorado Springs, Colorado, 80904

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907

  • Delta Waves, Inc

    Colorado Springs, Colorado, 80918

  • Axiom Research, LLC

    Colton, California, 92324

  • Vista Clinical Research

    Columbia, South Carolina, 29201

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Aventiv Research Inc.

    Columbus, Ohio, 43213

  • Clinical Research South Florida

    Coral Gables, Florida, 33134

  • Texas Neurology, P.A.

    Dallas, Texas, 75214

  • Futuresearch Trials of Dallas, LP

    Dallas, Texas, 75231

  • Radiant Research, Inc.

    Dallas, Texas, 75234

  • Associated Neurologists, PC

    Danbury, Connecticut, 06810

  • Avail Clinical Research

    DeLand, Florida, 32720

  • Denver Neurological Research

    Denver, Colorado, 80210

  • J. Lewis Research, Inc. / Foothill Family Clinic Draper

    Draper, Utah, 84020

  • Pharmacology Research Institute

    Encino, California, 91316

  • Encino Research Center/T Joseph Raoof MD Inc

    Encino, California, 91436

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760

  • Summit Headache and Neurologic Institute

    Englewood, Colorado, 80113

  • Deaconess Clinic Inc.

    Evansville, Indiana, 47713

  • Associated Neurologists of Southern Connecticut, PC

    Fairfield, Connecticut, 06824

  • Plains Clinical Research Center, LLC

    Fargo, North Dakota, 58104

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Middle Tennessee Clinical Research

    Fayetteville, Tennessee, 37334

  • Advanced Neurosciences Research

    Fort Collins, Colorado, 80528

  • Prairie Fields Family Medicine

    Fremont, Nebraska, 68025

  • Neuro-Pain Medical Center, Inc

    Fresno, California, 93710

  • California Headache and Balance Center

    Fresno, California, 93720

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • Behavioral Research Specialists, LLC

    Glendale, California, 91206

  • The Minneapolis Clinic of Neurology, Ltd.

    Golden Valley, Minnesota, 55422

  • Headache Wellness Center

    Greensboro, North Carolina, 27405

  • Wilks & Safirstein MD PA D/B/A MD Clinical

    Hallandale, Florida, 33009

  • Neurology Associates, P.A.

    Hickory, North Carolina, 28602

  • Infinity Clinical Research

    Hollywood, Florida, 33021

  • Broward Research

    Hollywood, Florida, 33024

  • Principals Research Group, Inc.

    Hot Springs, Arkansas, 71901

  • Research Trials Worldwide, LLC

    Humble, Texas, 77338

  • Sun Valley Research Center

    Imperial, California, 92251

  • Josephson Wallack Munshower Neurology, P.C.

    Indianapolis, Indiana, 46256

  • Clinical Neuroscience Solutions Inc

    Jacksonville, Florida, 32256

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • Women's Health Care Specialists

    Kalamazoo, Michigan, 49009

  • Holston Medical Group, P.C.

    Kingsport, Tennessee, 37660

  • New Orleans Center for Clinical Research

    Knoxville, Tennessee, 37920

  • Grossmont Center For Clinical Research

    La Mesa, California, 91942

  • Red Star Research, LLC

    Lake Jackson, Texas, 77566

  • Diagnostic Center of Medicine - Durango / Radiant Research, Inc.

    Las Vegas, Nevada, 89117

  • Rowe Neurology Institute

    Lenexa, Kansas, 66214

  • Lincoln Research

    Lincoln, Rhode Island, 02865

  • Arkansas Clinical Research

    Little Rock, Arkansas, 72205

  • Collaborative Neuroscience Network, LLC

    Long Beach, California, 90806

  • Pharmacology Research Institute

    Los Alamitos, California, 90270

  • Pacific Institute of Medical Research

    Los Angeles, California, 90024

  • Norton Neurology Services

    Louisville, Kentucky, 40207

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Neurology Associates, P.A.

    Maitland, Florida, 32751

  • Central New York Clinical Research

    Manlius, New York, 13104

  • CNS Healthcare

    Memphis, Tennessee, 38119

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • Desert Clinical Research /Radiant Research, Inc.

    Mesa, Arizona, 85213

  • LCC Medical Research

    Miami, Florida, 33126

  • Well Pharma Medical Research

    Miami, Florida, 33143

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402

  • Lake Shore Clinical Research, LLC

    Mooresville, North Carolina, 28117

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Synergy San Diego

    National City, California, 91950

  • BTC of New Bedford

    New Bedford, Massachusetts, 02470

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Newport Beach Clinical Research Associates, Inc.

    Newport Beach, California, 92663

  • Clinical Research Associates Tidewater

    Norfolk, Virginia, 23507

  • Northeast Medical Research Associates, Inc.

    North Dartmouth, Massachusetts, 02747

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Sensible Healthcare, LLC

    Ocoee, Florida, 34761

  • Advanced Research Institute

    Ogden, Utah, 84403

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • NPC Research

    Oklahoma City, Oklahoma, 73109

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Sooner Clinical Research Inc

    Oklahoma City, Oklahoma, 73112

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654

  • Clinical Research Advantage, Inc/Synexus USA

    Omaha, Nebraska, 68114

  • Quality Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Meridian Clinical Research

    Omaha, Nebraska, 68134

  • Clinical Neuroscience Solutions, Inc - Memphis, TN

    Orlando, Florida, 32801

  • College Park Family Care Center Physicians Group- Neurology Research Dept

    Overland Park, Kansas, 66210

  • Kansas Institute of Research

    Overland Park, Kansas, 66211

  • Palm Beach Neurological Center / Advanced Research Consultants, Inc.

    Palm Beach Gardens, Florida, 33410

  • Clinical Research Philadelphia

    Philadelphia, Pennsylvania, 19114

  • Xenoscience, Inc.

    Phoenix, Arizona, 85004

  • Central Phoenix Medical Clinic

    Phoenix, Arizona, 85020

  • Preferred Primary Care Physicians, Inc.

    Pittsburgh, Pennsylvania, 15236

  • Summit Research Network Inc.

    Portland, Oregon, 97210

  • Oregon Center For Clinical Investigations Inc

    Portland, Oregon, 97214

  • Princeton Medical Institute

    Princeton, New Jersey, 08540

  • Beacon Clinical Research, LLC

    Quincy, Massachusetts, 02169

  • Wake Research Associates LLC

    Raleigh, North Carolina, 27612

  • Rancho Cucamonga Clinical Research

    Rancho Cucamonga, California, 91730

  • Desert Valley Research

    Rancho Mirage, California, 92270

  • George J Rederich MD, Inc.

    Redondo Beach, California, 90277

  • The Headache Center

    Ridgeland, Mississippi, 39157

  • Granger Medical Clinic - Riverton

    Riverton, Utah, 84065

  • Robbins Headache Clinic

    Riverwoods, Illinois, 60015

  • Blue Ridge Research Center

    Roanoke, Virginia, 24018

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Optimum Clinical Research, Inc.

    Salt Lake City, Utah, 84102

  • Highland Clinical Reserach

    Salt Lake City, Utah, 84124

  • Clinical Trials Texas, Inc

    San Antonio, Texas, 78229

  • Road Runner Research

    San Antonio, Texas, 78258

  • Artemis Institute For Clinical Research

    San Diego, California, 92103

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • California Medical Clinic for Headache

    Santa Monica, California, 90404

  • The Polyclinic

    Seattle, Washington, 98104

  • Southern California Research Center

    Simi Valley, California, 93065

  • Hillcrest Clinical Research LLC

    Simpsonville, South Carolina, 29681

  • Princeton Center for Clinical Research

    Skillman, New Jersey, 08558

  • Qps Mra, Llc

    South Miami, Florida, 33143

  • Meridien Research

    Spring Hill, Florida, 34609

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Clinvest

    Springfield, Missouri, 65807

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • South Puget Sound Neurology

    Tacoma, Washington, 98409

  • University of South Florida

    Tampa, Florida, 33612

  • Meridien Research

    Tampa, Florida, 33634

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Radiant Research Inc.

    Tucson, Arizona, 85712

  • Orange Grove Family Practice/Radiant Research, Inc.

    Tucson, Arizona, 85741

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Tidewater Integrated Medical Research

    Virginia Beach, Virginia, 23454

  • Sentara Neurology Specialists

    Virginia Beach, Virginia, 23456

  • Radiant Research

    Vista, California, 92083

  • Medvadis Research Corporation

    Watertown, Massachusetts, 02472

  • Neurology Research Institute Palm Beach

    West Palm Beach, Florida, 33407

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • New England Regional Headache Center

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Ubrogepant, Placebo-matching Ubrogepant, Usual Care
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UbrogepantDrug

    Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

  • Placebo-matching UbrogepantDrug

    Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.

  • Usual CareDrug

    Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.

Study groups in NCT02873221
Study groupRoleWhat they receive
Usual CareActive comparatorUsual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year.
Receives: Drug: Usual Care
Ubrogepant 50 mgExperimentalUbrogepant 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.
Receives: Drug: Ubrogepant; Drug: Placebo-matching Ubrogepant
Ubrogepant 100 mgExperimentalUbrogepant 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.
Receives: Drug: Ubrogepant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 56 Weeks

Secondary outcomes (4)

  1. 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.

    Measured: 56 Weeks

  2. 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.

    Measured: 56 Weeks

  3. 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.

    Measured: 56 Weeks

  4. 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"

    Measured: 56 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2016 (estimated)
  2. Study start13 Sep 2016
  3. Primary completion2 Aug 2018
  4. Study completion2 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02873221
Sponsor's protocol ID
UBR-MD-04
Status last verified
Aug 2019
First submitted
16 Aug 2016
Last updated
28 Aug 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 35977836

  • 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.

    PubMed 34874514

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ubrogepant in people with Migraine, With or Without Aura, run by Allergan at 177 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (time frame: 56 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02873221, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.

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