Phase
Condition
Chronic Pain
Migraine (Adult)
Oral Facial Pain
Treatment
Ubrogepant
Placebo-Matching Ubrogepant
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A history of migraine with or without aura consistent with a diagnosis according tothe International Classification of Headache Disorders (ICHD-3) for at least 6months.
By history, the participant's migraines typically last between 3 and 72 hours ifuntreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom.
History of 1 to 14 migraine attacks per month with moderate to severe headache ineach of the 2 months prior to screening (Visit 1).
Current or past use of at least 1 oral medication (over-the-counter medication orprescription medication) for the acute treatment of migraine.
For main study participants, treatment of a qualifying migraine with single-blindplacebo during the screening period and completion of 2-hour headache painassessment.
Weight is ≥ 20 kg (44 pounds) and < 135 kg (298 pounds)
Per investigator judgment, participant is able to swallow or can learn to swallowstudy intervention.
The participant is able to understand and complete the study questionnaires andeDiary. Participants who need assistance with reading the assessments may beassisted by a parent or guardian.
Exclusion
Exclusion Criteria:
Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic,gastrointestinal, cardiovascular or neurologic disease.
In the opinion of the investigator, other confounding pain syndromes, confoundingpsychiatric conditions, or other significant neurological disorders other thanmigraine.
History of malignancy in the 5 years prior to Visit 1.
History of any prior gastrointestinal conditions (eg, diarrhea syndromes,inflammatory bowel disease) that may affect the absorption or metabolism of thestudy intervention.
Significant risk of self-harm, based on clinical interview and responses on theColumbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others; participantsmust be excluded if they report suicidal ideation with intent, with or without aplan, (ie, Type 4 or 5 on the C-SSRS) in the past 6 months or report suicidalbehavior in the last 6 months prior to Visit 1 or Visit 2 assessments.
At Visit 1, current alcohol or drug abuse or dependence per investigator's judgment.
For main study participants, no headache at the 2-hour post dose assessment aftertaking single-blind placebo for a qualifying migraine during screening period (ie,placebo responder).
A current diagnosis of chronic migraine as defined by ICHD-3
Participants who overuse medication for migraine defined as use of opioids orbarbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 15 days/month or any combination of triptans,ergots, or simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 10 days/month inthe 3 months prior to Visit 1 per investigator's judgment.
Difficulty distinguishing migraine headache from tension-type or other headaches.
Has a history of migraine aura with diplopia or impairment of level ofconsciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
Has a current diagnosis of new persistent daily headache, trigeminal autonomiccephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3
Required in-hospital (excluding emergency department visits) treatment for migraines 3 or more times in the 6 months prior to Visit 1.
Requirement for any medication (eg, barbiturates) or diet (eg, grapefruit juice)that is on the list of prohibited concomitant medications that cannot bediscontinued or switched to an allowable, alternative medication at Visit 1.
Previous exposure, within the last 6 months, to injectable monoclonal antibodiesblocking the calcitonin gene-related peptide (CGRP) pathway
History of hypersensitivity or clinically significant adverse reaction to a CGRPreceptor antagonist or hypersensitivity to any component of the study interventions,ubrogepant or placebo.
Currently participating or has participated in a study with an investigationalcompound or device within 30 days prior to Visit 1
Study Design
Connect with a study center
Clinical Research Investigator Group, LLC /ID# 267454
Bayamon, 00960
Puerto RicoActive - Recruiting
Puerto Rico Health Institute /ID# 249162
Dorado, 00646
Puerto RicoActive - Recruiting
Ponce Medical School Foundation /ID# 250612
Ponce, 00716-0377
Puerto RicoSite Not Available
Caribbean Medical Research Center /ID# 265301
San Juan, 00918-3501
Puerto RicoActive - Recruiting
GCM Medical Group PSC /ID# 249643
San Juan, 00917-3104
Puerto RicoActive - Recruiting
Rehabilitation & Neurological Services /ID# 229969
Huntsville, Alabama 35805-4046
United StatesActive - Recruiting
The Center for Clinical Trials - Saraland /ID# 231546
Saraland, Alabama 36571
United StatesActive - Recruiting
Preferred Research Partners /ID# 230725
Little Rock, Arkansas 72211
United StatesActive - Recruiting
Advanced Research Center /ID# 227962
Anaheim, California 92805
United StatesActive - Recruiting
Neuro Pain Medical Center /ID# 227966
Fresno, California 93710-5473
United StatesActive - Recruiting
Sunwise Clinical Research /ID# 230971
Lafayette, California 94549-4579
United StatesSite Not Available
Alliance for Research - Long Beach /ID# 230546
Long Beach, California 90807
United StatesActive - Recruiting
Alliance for Research Alliance for Wellness /ID# 230546
Long Beach, California 90807
United StatesActive - Recruiting
Children's Hospital Los Angeles /ID# 230596
Los Angeles, California 90027
United StatesCompleted
Excell Research, Inc /ID# 230899
Oceanside, California 92056
United StatesActive - Recruiting
Paradigm Clinical Research - San Diego /ID# 269608
San Diego, California 92108-1681
United StatesActive - Recruiting
Rady Children's Hospital San Diego /ID# 243201
San Diego, California 92123
United StatesSite Not Available
Lumos Clinical Research Center /ID# 231267
San Jose, California 95124-4108
United StatesActive - Recruiting
Pacific Clinical Research Management Group /ID# 231636
Upland, California 91786
United StatesActive - Recruiting
Sunwise Clinical Research /ID# 230971
Walnut Creek, California 94596
United StatesActive - Recruiting
Children's Hospital Colorado - Aurora /ID# 231879
Aurora, Colorado 80045
United StatesActive - Recruiting
Children's Hospital Colorado /ID# 231879
Aurora, Colorado 80045
United StatesActive - Recruiting
IMMUNOe Research Centers /ID# 230879
Centennial, Colorado 80112
United StatesCompleted
MCB Clinical Research Centers /ID# 231625
Colorado Springs, Colorado 80910
United StatesCompleted
Velocity Clinical Research - Denver /ID# 232035
Denver, Colorado 80209-3804
United StatesSite Not Available
New England Institute for Clinical Research /ID# 230635
Stamford, Connecticut 06905
United StatesActive - Recruiting
Emerson Clinical Research Inst /ID# 231693
Washington, District of Columbia 20011
United StatesActive - Recruiting
Encore Medical Research of Boynton Beach LLC /ID# 246833
Boynton Beach, Florida 33436-7245
United StatesActive - Recruiting
Gulf Coast Clinical Research Center /ID# 230020
Fort Myers, Florida 33912
United StatesActive - Recruiting
Gulfcoast Clinical Research Center /ID# 230020
Fort Myers, Florida 33912
United StatesActive - Recruiting
Sarkis Clinical Trials /ID# 227956
Gainesville, Florida 32607
United StatesCompleted
Northwest Florida Clinical Research Group, LLC /ID# 231069
Gulf Breeze, Florida 32561-4495
United StatesCompleted
A.G.A Clinical Trials /ID# 230554
Hialeah, Florida 33012
United StatesActive - Recruiting
Encore Medical Research /ID# 245682
Hollywood, Florida 33021
United StatesActive - Recruiting
Encore Medical Research LLC /ID# 245682
Hollywood, Florida 33021-6476
United StatesActive - Recruiting
Advanced Research Institute of Miami /ID# 230292
Homestead, Florida 33030-4613
United StatesActive - Recruiting
Multi-Speciality Research Associates /ID# 229595
Lake City, Florida 32055-8835
United StatesSite Not Available
Auzmer Research /ID# 239251
Lakeland, Florida 33813-2768
United StatesActive - Recruiting
Columbus Clinical Services, Llc /Id# 230880
Miami, Florida 33125-5114
United StatesActive - Recruiting
My Preferred Research LLC /ID# 227886
Miami, Florida 33155
United StatesActive - Recruiting
Neurology & Pain Medicine /ID# 240168
Miami, Florida 33186-7661
United StatesCompleted
Medical Research Group of Central Florida /ID# 231632
Orange City, Florida 32763
United StatesActive - Recruiting
Clinical Associates of Orlando, LLC /ID# 272619
Orlando, Florida 32819
United StatesActive - Recruiting
Suncoast Clinical Research - Palm Harbor /ID# 229337
Palm Harbor, Florida 34684
United StatesActive - Recruiting
Bioresearch Institute LLC /ID# 230909
Pembroke Pines, Florida 33026-4383
United StatesSite Not Available
South Florida Urgent Care - Pembroke Pines /ID# 239977
Pembroke Pines, Florida 33029-2818
United StatesSite Not Available
Asclepes Research Centers - Spring Hill /ID# 229815
Spring Hill, Florida 34609-5692
United StatesActive - Recruiting
Segal Trials - West Broward Outpatient Research Site /ID# 231930
Tamarac, Florida 33319-4985
United StatesSite Not Available
University of South Florida /ID# 229324
Tampa, Florida 33612
United StatesActive - Recruiting
University of South Florida- Neuroscience Institute /ID# 229324
Tampa, Florida 33613
United StatesActive - Recruiting
Encore Medical Research - Weston /ID# 246809
Weston, Florida 33331
United StatesActive - Recruiting
Encore Medical Research of Weston LLC /ID# 246809
Weston, Florida 33331-3642
United StatesActive - Recruiting
Pediatric Neurology and Epilepsy Specialists /ID# 229967
Winter Park, Florida 32789-7111
United StatesActive - Recruiting
Pediatrix Medical Group of Florida /ID# 229967
Winter Park, Florida 32789-7111
United StatesActive - Recruiting
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134
Atlanta, Georgia 30328
United StatesActive - Recruiting
Rare Disease Research, LLC /ID# 231046
Atlanta, Georgia 30318-2512
United StatesActive - Recruiting
Treken Primary Care /ID# 240586
Atlanta, Georgia 30315
United StatesCompleted
Coastal Georgia Child Neurology /ID# 231409
Brunswick, Georgia 31520-1601
United StatesActive - Recruiting
CenExcel iResearch LLC /ID# 227903
Decatur, Georgia 30030
United StatesActive - Recruiting
Meridian Clinical Research LLC /ID# 228992
Savannah, Georgia 31406
United StatesActive - Recruiting
Velocity Clinical Research - Savannah /ID# 228992
Savannah, Georgia 31406
United StatesActive - Recruiting
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738
Stockbridge, Georgia 30281
United StatesCompleted
Velocity Clinical Research - Boise /ID# 231871
Meridian, Idaho 83642
United StatesActive - Recruiting
Chicago Headache Center & Research Institute /ID# 248625
Chicago, Illinois 60657
United StatesActive - Recruiting
Accellacare - McFarland Clinic /ID# 229789
Ames, Iowa 50010
United StatesActive - Recruiting
Accellacare /ID# 229789
Ames, Iowa 50010
United StatesActive - Recruiting
College Park Family Care Center Overland Park /ID# 231456
Overland Park, Kansas 66210-2761
United StatesCompleted
Psychiatric Associates /ID# 230872
Overland Park, Kansas 66221
United StatesCompleted
Alliance for Multispecialty Research (AMR) - Wichita West /ID# 234126
Wichita, Kansas 67205-1138
United StatesActive - Recruiting
University of Kentucky Chandler Medical Center /ID# 230827
Lexington, Kentucky 40536
United StatesActive - Recruiting
Pharmasite Research, Inc. /ID# 227908
Baltimore, Maryland 21208
United StatesActive - Recruiting
Michigan Headache & Neurological Institute (MHNI) /ID# 229150
Ann Arbor, Michigan 48104-5131
United StatesSite Not Available
NeuroBehavioral Medicine Group /ID# 231149
Bloomfield Hills, Michigan 48302
United StatesSite Not Available
Minneapolis Clinic of Neurology - Burnsville /ID# 232551
Burnsville, Minnesota 55337-6732
United StatesActive - Recruiting
Clinical Research Institute, Inc /ID# 227872
Minneapolis, Minnesota 55402-2606
United StatesSite Not Available
MediSync Clinical Research Hattiesburg Clinic /ID# 233326
Petal, Mississippi 39465-2932
United StatesCompleted
Proven Endpoints LLC /ID# 239513
Ridgeland, Mississippi 39157
United StatesActive - Recruiting
Sharlin Health Neuroscience Research Center /ID# 229523
Ozark, Missouri 65721-5315
United StatesActive - Recruiting
Cognitive Clinical Trials (CCT) - Papillion /ID# 232552
Papillion, Nebraska 68046-4131
United StatesActive - Recruiting
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312
Nashua, New Hampshire 03060-3483
United StatesActive - Recruiting
Hunterdon Neurology /ID# 245648
Annandale, New Jersey 08801-3127
United StatesCompleted
Goryeb Children's Hospital /ID# 229507
Morristown, New Jersey 07960
United StatesActive - Recruiting
CVS HealthHUB - Runnemede /ID# 234233
Runnemede, New Jersey 08078-1034
United StatesCompleted
Dent Neurologic Institute - Amherst /ID# 231182
Amherst, New York 14226
United StatesActive - Recruiting
Dent Neurosciences Research Center, Inc. /ID# 231182
Amherst, New York 14226
United StatesActive - Recruiting
Bioscience Research /ID# 232159
Mount Kisco, New York 10549-3028
United StatesActive - Recruiting
Modern Migraine MD /ID# 258081
New York, New York 10001
United StatesActive - Recruiting
North Suffolk Neurology /ID# 230956
Port Jefferson Station, New York 11776-3387
United StatesCompleted
SUNY Upstate Medical University /ID# 239898
Syracuse, New York 13210
United StatesActive - Recruiting
CVS HealthHUB - Charlotte /ID# 239530
Charlotte, North Carolina 28210-8905
United StatesCompleted
OnSite Clinical Solutions, LLC - Hickory /ID# 227994
Hickory, North Carolina 28601
United StatesCompleted
Cincinnati Childrens Hospital Medical Center /ID# 244689
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Headache Center of Hope /ID# 242645
Cincinnati, Ohio 45236-1875
United StatesActive - Recruiting
Patient Priority Clinical Sites, LLC /ID# 238485
Cincinnati, Ohio 45215-2123
United StatesActive - Recruiting
University Of Cincinnati Medical Center /ID# 231199
Cincinnati, Ohio 45219
United StatesActive - Recruiting
University of Cincinnati /ID# 231199
Cincinnati, Ohio 45267-0585
United StatesActive - Recruiting
Centricity Research Columbus /ID# 231181
Columbus, Ohio 43213
United StatesActive - Recruiting
CincyScience /ID# 230046
West Chester, Ohio 45069
United StatesActive - Recruiting
IPS Research Company /ID# 227961
Oklahoma City, Oklahoma 73106
United StatesCompleted
Providence Brain and Spine Institute /ID# 231607
Portland, Oregon 97225-6625
United StatesActive - Recruiting
Children's Hospital of Philadelphia - Main /ID# 232487
Philadelphia, Pennsylvania 19104-4319
United StatesActive - Recruiting
Frontier Clinical Research, LLC - Scottdale /ID# 231913
Scottdale, Pennsylvania 15683
United StatesActive - Recruiting
Frontier Clinical Research /ID# 231912
Smithfield, Pennsylvania 15478
United StatesActive - Recruiting
Coastal Pediatric Research /ID# 238616
Charleston, South Carolina 29414-5834
United StatesActive - Recruiting
Tribe Clinical Research LLC /ID# 230422
Greenville, South Carolina 29607-4021
United StatesActive - Recruiting
Duplicate_Premier Neurology, P.C. /ID# 227999
Greer, South Carolina 29650
United StatesCompleted
Premier Neurology, P.C. /ID# 227999
Greer, South Carolina 29650
United StatesCompleted
Memphis Neurology - Germantown /ID# 245284
Germantown, Tennessee 38138-1751
United StatesSite Not Available
Le Bonheur Children's Hospital /ID# 244715
Memphis, Tennessee 38103
United StatesSite Not Available
Access Clinical Trials, Inc. /ID# 228002
Nashville, Tennessee 37203
United StatesActive - Recruiting
BioBehavioral Research of Austin /ID# 230529
Austin, Texas 78759
United StatesCompleted
UT Health Austin at Dell Children's Neurology Clinic /ID# 244266
Austin, Texas 78723-3079
United StatesActive - Recruiting
Velocity Clinical Research, Austin /ID# 230557
Austin, Texas 78759
United StatesActive - Recruiting
Tekton Research - Beaumont /ID# 231207
Beaumont, Texas 77706-3067
United StatesActive - Recruiting
Velocity Clinical Research - Austin /ID# 230557
Cedar Park, Texas 78613-3513
United StatesSite Not Available
Cedar Health Research /ID# 228003
Dallas, Texas 75251-2202
United StatesActive - Recruiting
Relaro Medical Trials /ID# 239642
Dallas, Texas 75243
United StatesActive - Recruiting
3A Research - East El Paso /ID# 239193
El Paso, Texas 79925-7945
United StatesActive - Recruiting
Earle Research /ID# 231548
Friendswood, Texas 77546
United StatesCompleted
DM Clinical Research /ID# 229826
Houston, Texas 77065
United StatesActive - Recruiting
Houston Clinical Research Associates /ID# 244889
Houston, Texas 77090-2633
United StatesActive - Recruiting
Research Trials Worldwide /ID# 230896
Humble, Texas 77338-3501
United StatesSite Not Available
Sante Clinical Research /ID# 246503
Kerrville, Texas 78028-9640
United StatesActive - Recruiting
FMC Science /ID# 231915
Lampasas, Texas 76550
United StatesActive - Recruiting
Livingspring Family Medical Center /ID# 249869
Mansfield, Texas 76063-5622
United StatesActive - Recruiting
AIM Trials /ID# 230142
Plano, Texas 75093
United StatesActive - Recruiting
Road Runner Research /ID# 230527
San Antonio, Texas 78249-3538
United StatesActive - Recruiting
Family Psychiatry of The Woodlands /ID# 230163
The Woodlands, Texas 77381
United StatesActive - Recruiting
ClinPoint Trials /ID# 230295
Waxahachie, Texas 75165-1430
United StatesActive - Recruiting
Pantheon Clinical Research /ID# 250703
Bountiful, Utah 84010-4968
United StatesActive - Recruiting
Highland Clinical Research /ID# 239362
Salt Lake City, Utah 84124
United StatesActive - Recruiting
University of Utah Health Hospital /ID# 230908
Salt Lake City, Utah 84132
United StatesCompleted
University of Utah School of Medicine /ID# 230908
Salt Lake City, Utah 84132-0002
United StatesActive - Recruiting
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976
Woodstock, Vermont 05091
United StatesCompleted
Office of Maria Ona /ID# 234232
Franklin, Virginia 23851
United StatesCompleted
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581
Norfolk, Virginia 23507-1901
United StatesActive - Recruiting
National Clinical Research /ID# 231320
Richmond, Virginia 23294
United StatesCompleted
Core Clinical Research /ID# 227904
Everett, Washington 98201
United StatesActive - Recruiting
Frontier Clinical Research - Kingwood /ID# 231914
Kingwood, West Virginia 26537-9797
United StatesActive - Recruiting
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