Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)
Start Date
1/13/2022
Completion Date
5/1/2027
Summary
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment. For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, at least 2 hours after the initial dose, for headache of moderate/severe intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Eligibility Criteria
Age Range: 6 years to 17 years
Interventions
Ubrogepant
Placebo-Matching Ubrogepant
Conditions
Locations
Rehabilitation & Neurological Services /ID# 229969
Huntsville, Alabama 35805-4046
United States
The Center for Clinical Trials - Saraland /ID# 231546
Saraland, Alabama 36571
United States
Rezen Clinical Trials /ID# 282831
Glendale, Arizona 85306
United States
Velocity Clinical Research - Phoenix /ID# 274478
Phoenix, Arizona 85006
United States
HealthStar Research Glenwood /ID# 275303
Glenwood, Arkansas 71943
United States
HealthStar Research of Hot Springs /ID# 273256
Hot Springs, Arkansas 71913
United States
Preferred Research Partners /ID# 230725
Little Rock, Arkansas 72211
United States
Advanced Research Center /ID# 227962
Anaheim, California 92805
United States
Neuro Pain Research Center /ID# 227966
Fresno, California 93710
United States
Alliance for Research Alliance for Wellness /ID# 230546
Long Beach, California 90807
United States
Children's Hospital Los Angeles /ID# 230596
Los Angeles, California 90027
United States
Excell Research, Inc /ID# 230899
Oceanside, California 92056
United States
Paradigm Clinical Research - San Diego /ID# 269608
San Diego, California 92108-1681
United States
Lumos Clinical Research Center /ID# 231267
San Jose, California 95124-4108
United States
Pacific Clinical Research Management Group /ID# 231636
Upland, California 91786
United States
Sunwise Clinical Research /ID# 230971
Walnut Creek, California 94596
United States
Amicis Research Center /ID# 272621
Winnetka, California 91306
United States
Children's Hospital Colorado - Aurora /ID# 231879
Aurora, Colorado 80045
United States
IMMUNOe Research Centers /ID# 230879
Centennial, Colorado 80112
United States
MCB Clinical Research Centers - Colorado Springs - South Parkside Drive /ID# 231625
Colorado Springs, Colorado 80910
United States
New England Institute for Clinical Research /ID# 230635
Stamford, Connecticut 06905
United States
Emerson Clinical Research Institute - Connecticut Avenue - Washington /ID# 231693
Washington D.C., District of Columbia 20009
United States
Encore Medical Research of Boynton Beach LLC /ID# 246833
Boynton Beach, Florida 33436-7245
United States
Gulf Coast Clinical Research Center /ID# 230020
Fort Myers, Florida 33912
United States
Sarkis Clinical Trials /ID# 227956
Gainesville, Florida 32607
United States
Northwest Florida Clinical Research Group, LLC /ID# 231069
Gulf Breeze, Florida 32561-4495
United States
AGA Clinical Trials /ID# 230554
Hialeah, Florida 33012
United States
Encore Medical Research /ID# 245682
Hollywood, Florida 33021
United States
Advanced Research Institute of Miami /ID# 230292
Homestead, Florida 33030-4613
United States
Auzmer Research /ID# 239251
Lakeland, Florida 33813-2768
United States
Columbus Clinical Services, Llc /Id# 230880
Miami, Florida 33125
United States
My Preferred Research LLC /ID# 227886
Miami, Florida 33155
United States
Neurology & Pain Medicine /ID# 240168
Miami, Florida 33186-7661
United States
Medical Research Group of Central Florida /ID# 231632
Orange City, Florida 32763
United States
Clinical Associates of Orlando, LLC /ID# 272619
Orlando, Florida 32819
United States
Suncoast Clinical Research - Palm Harbor /ID# 229337
Palm Harbor, Florida 34684
United States
FWD Clinical Research - Spring Hill /ID# 229815
Spring Hill, Florida 34609-5692
United States
University of South Florida- Neuroscience Institute /ID# 229324
Tampa, Florida 33613
United States
Encore Medical Research - Weston /ID# 246809
Weston, Florida 33331
United States
Pediatric Neurology and Epilepsy Specialists /ID# 229967
Winter Park, Florida 32789-7111
United States
Treken Primary Care /ID# 240586
Atlanta, Georgia 30315
United States
Rare Disease Research /ID# 231046
Atlanta, Georgia 30318-2512
United States
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134
Atlanta, Georgia 30328
United States
Coastal Georgia Child Neurology /ID# 231409
Brunswick, Georgia 31520-1601
United States
CenExcel iResearch LLC /ID# 227903
Decatur, Georgia 30030
United States
Velocity Clinical Research - Savannah. /ID# 228992
Savannah, Georgia 31406
United States
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738
Stockbridge, Georgia 30281
United States
Velocity Clinical Research - Boise /ID# 231871
Meridian, Idaho 83642
United States
Chicago Headache Center & Research Institute /ID# 248625
Chicago, Illinois 60657
United States
Ascension Saint Alexius /ID# 275261
Hoffman Estates, Illinois 60169
United States
Accellacare - McFarland Clinic /ID# 229789
Ames, Iowa 50010
United States
MercyOne Northeast Iowa Family Medicine & Residency /ID# 282810
Waterloo, Iowa 50702
United States
College Park Family Care Center Overland Park /ID# 231456
Overland Park, Kansas 66210-2761
United States
Clinical Associates Midwest, LLC /ID# 274315
Overland Park, Kansas 66214
United States
Psychiatric Associates /ID# 230872
Overland Park, Kansas 66221
United States
Alliance For Multispeciality Research - Wichita East /ID# 234126
Wichita, Kansas 67207
United States
University of Kentucky Chandler Medical Center /ID# 230827
Lexington, Kentucky 40536
United States
Pharmasite Research, Inc. /ID# 227908
Baltimore, Maryland 21208
United States
Minneapolis Clinic of Neurology - Burnsville /ID# 232551
Burnsville, Minnesota 55337-6732
United States
MediSync Clinical Research Hattiesburg Clinic /ID# 233326
Petal, Mississippi 39465-2932
United States
Proven Endpoints LLC /ID# 239513
Ridgeland, Mississippi 39157
United States
Sharlin Health and Neurology /ID# 229523
Ozark, Missouri 65721
United States
Cognitive Clinical Trials (CCT) - Papillion /ID# 232552
Papillion, Nebraska 68046-4131
United States
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312
Nashua, New Hampshire 03060-3483
United States
Hunterdon Neurology /ID# 245648
Annandale, New Jersey 08801-3127
United States
Goryeb Childrens Hospital /ID# 229507
Morristown, New Jersey 07960
United States
CVS HealthHUB - Runnemede /ID# 234233
Runnemede, New Jersey 08078-1034
United States
Dent Neurologic Institute - Amherst /ID# 231182
Amherst, New York 14226
United States
Duplicate_Bioscience Research /ID# 232159
Mount Kisco, New York 10549-3028
United States
Modern Migraine MD /ID# 258081
New York, New York 10001
United States
North Suffolk Neurology /ID# 230956
Port Jefferson Station, New York 11776-3387
United States
Hawthorne Health - Staten Island /ID# 283144
Staten Island, New York 10309
United States
SUNY Upstate Medical University /ID# 239898
Syracuse, New York 13210
United States
CVS HealthHUB - Charlotte /ID# 239530
Charlotte, North Carolina 28210-8905
United States
OnSite Clinical Solutions - Ninth Ave Drive North East - Hickory /ID# 227994
Hickory, North Carolina 28601
United States
Patient Priority Clinical Sites, LLC /ID# 238485
Cincinnati, Ohio 45215-2123
United States
University Of Cincinnati Medical Center /ID# 231199
Cincinnati, Ohio 45219
United States
Cincinnati Childrens Hospital Medical Center /ID# 244689
Cincinnati, Ohio 45229
United States
Headache Center of Hope /ID# 242645
Cincinnati, Ohio 45236-1875
United States
Centricity Research Columbus /ID# 231181
Columbus, Ohio 43213
United States
CincyScience /ID# 230046
West Chester, Ohio 45069
United States
IPS Research Company /ID# 227961
Oklahoma City, Oklahoma 73106
United States
Providence Brain and Spine Institute /ID# 231607
Portland, Oregon 97225-6625
United States
Hawthorne Health - Horsham /ID# 283151
Horsham, Pennsylvania 19044
United States
Children's Hospital of Philadelphia - Main /ID# 232487
Philadelphia, Pennsylvania 19104-4319
United States
Frontier Clinical Research - Scottdale /ID# 231913
Scottdale, Pennsylvania 15683
United States
Frontier Clinical Research - Smithfield /ID# 231912
Smithfield, Pennsylvania 15478
United States
Coastal Pediatric Research /ID# 238616
Charleston, South Carolina 29414-5834
United States
Tribe Clinical Research LLC /ID# 230422
Greenville, South Carolina 29607-4021
United States
Duplicate_Premier Neurology, P.C. /ID# 227999
Greer, South Carolina 29650
United States
Hawthorne Health - Lebanon /ID# 283149
Lebanon, Tennessee 37087
United States
Access Clinical Trials, Inc. /ID# 228002
Nashville, Tennessee 37203
United States
UT Health Austin at Dell Children's Neurology Clinic /ID# 244266
Austin, Texas 78723-3079
United States
Austin Regional Clinic - ARC Four Points /ID# 276301
Austin, Texas 78726
United States
BioBehavioral Research of Austin /ID# 230529
Austin, Texas 78759
United States
Velocity Clinical Research, Austin /ID# 230557
Austin, Texas 78759
United States
Tekton Research - Beaumont /ID# 231207
Beaumont, Texas 77706-3067
United States
Relaro Medical Trials /ID# 239642
Dallas, Texas 75243
United States
Cedar Health Research /ID# 228003
Dallas, Texas 75251-2202
United States
Epic Medical Research - DeSoto /ID# 274314
DeSoto, Texas 75115
United States
3A Research - East El Paso /ID# 239193
El Paso, Texas 79925-7945
United States
Earle Research /ID# 231548
Friendswood, Texas 77546
United States
Innovare Research Group, LLC /ID# 277617
Friendswood, Texas 77546
United States
DM Clinical Research /ID# 229826
Houston, Texas 77065
United States
Aavon Clinical Trials /ID# 279007
Houston, Texas 77074
United States
Houston Clinical Research Associates /ID# 244889
Houston, Texas 77090-2633
United States
Pioneer Research Solutions - Houston - Stancliff Road /ID# 274316
Houston, Texas 77099
United States
Sante Clinical Research /ID# 246503
Kerrville, Texas 78028-9640
United States
FMC Science /ID# 231915
Lampasas, Texas 76550
United States
Livingspring Family Medical Center /ID# 249869
Mansfield, Texas 76063-5622
United States
AIM Trials /ID# 230142
Plano, Texas 75093
United States
Road Runner Research /ID# 230527
San Antonio, Texas 78249-3538
United States
Family Psychiatry of The Woodlands /ID# 230163
The Woodlands, Texas 77381
United States
ClinPoint Trials /ID# 230295
Waxahachie, Texas 75165-1430
United States
Pantheon Clinical Research /ID# 250703
Bountiful, Utah 84010-4968
United States
Highland Clinical Research /ID# 239362
Salt Lake City, Utah 84124
United States
University of Utah Health Hospital /ID# 230908
Salt Lake City, Utah 84132
United States
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976
Woodstock, Vermont 05091
United States
Office of Maria Ona /ID# 234232
Franklin, Virginia 23851
United States
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581
Norfolk, Virginia 23507-1901
United States
National Clinical Research /ID# 231320
Richmond, Virginia 23294
United States
Core Clinical Research /ID# 227904
Everett, Washington 98201
United States
MultiCare Institute for Research and Innovation /ID# 231061
Tacoma, Washington 98405
United States
Frontier Clinical Research - Kingwood /ID# 231914
Kingwood, West Virginia 26537-9797
United States
Mind+ Neurology /ID# 275529
Mequon, Wisconsin 53092
United States
Clinical Research Investigator Group /ID# 267454
Bayamón, 00960
Puerto Rico
Puerto Rico Health Institute /ID# 249162
Dorado, 00646
Puerto Rico
GCM Medical Group /ID# 249643
San Juan, 00917-3104
Puerto Rico
Caribbean Medical Research Center Headlands /ID# 265301
San Juan, 00918-3501
Puerto Rico