Actively Recruiting
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)
Led by AbbVie · Updated on 2026-05-13
1059
Participants Needed
124
Research Sites
276 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of migraine with or without aura for at least 6 months according to International Classification of Headache Disorders (ICHD-3)
- Migraines lasting between 3 and 72 hours if untreated or unsuccessfully treated, separated by at least 48 hours headache-free
- 1 to 14 migraine attacks per month with moderate to severe headache in each of the 2 months before screening
- Current or past use of at least one oral medication for acute migraine treatment
- For main study, must have treated a qualifying migraine with single-blind placebo during screening and completed 2-hour headache pain assessment
- Weight between 20 kg (44 pounds) and less than 135 kg (298 pounds)
- Able to swallow or learn to swallow study medication
- Able to understand and complete study questionnaires and electronic diary, with parent or guardian assistance if needed
You will not qualify if you...
- Clinically significant blood, endocrine, lung, kidney, liver, gastrointestinal, heart, or neurological disease other than migraine
- Other pain syndromes, psychiatric conditions, or neurological disorders that could affect results
- History of cancer in the 5 years before screening
- Prior gastrointestinal conditions affecting medication absorption or metabolism
- Significant risk of self-harm or harm to others based on clinical evaluation and suicide severity rating
- Current alcohol or drug abuse or dependence
- For main study, no headache relief 2 hours after single-blind placebo during screening (placebo responder)
- Diagnosis of chronic migraine as defined by ICHD-3
- Overuse of migraine medications exceeding specified limits in the 3 months before screening
- Difficulty distinguishing migraine from other headache types
- History of migraine with diplopia, level of consciousness impairment, hemiplegic migraine, or retinal migraine
- Diagnosis of new persistent daily headache, cluster headache, or painful cranial neuropathy
- Hospital treatment for migraines 3 or more times in the 6 months before screening
- Use of prohibited medications or diets that cannot be changed for the study
- Exposure in last 6 months to injectable monoclonal antibodies blocking the CGRP pathway
- Hypersensitivity to CGRP receptor antagonists, ubrogepant, placebo, or study components
- Participation in another investigational study within 30 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 124 locations
1
Rehabilitation & Neurological Services /ID# 229969
Huntsville, Alabama, United States, 35805-4046
Actively Recruiting
2
The Center for Clinical Trials - Saraland /ID# 231546
Saraland, Alabama, United States, 36571
Actively Recruiting
3
Velocity Clinical Research - Phoenix /ID# 274478
Phoenix, Arizona, United States, 85006
Actively Recruiting
4
HealthStar Research Glenwood /ID# 275303
Glenwood, Arkansas, United States, 71943
Actively Recruiting
5
HealthStar Research of Hot Springs PLLC /ID# 273256
Hot Springs, Arkansas, United States, 71913
Actively Recruiting
6
Preferred Research Partners /ID# 230725
Little Rock, Arkansas, United States, 72211
Actively Recruiting
7
Advanced Research Center /ID# 227962
Anaheim, California, United States, 92805
Actively Recruiting
8
Neuro Pain Research Center /ID# 227966
Fresno, California, United States, 93710
Actively Recruiting
9
Alliance for Research Alliance for Wellness /ID# 230546
Long Beach, California, United States, 90807
Actively Recruiting
10
Children's Hospital Los Angeles /ID# 230596
Los Angeles, California, United States, 90027
Completed
11
Excell Research, Inc /ID# 230899
Oceanside, California, United States, 92056
Actively Recruiting
12
Paradigm Clinical Research - San Diego /ID# 269608
San Diego, California, United States, 92108-1681
Actively Recruiting
13
Lumos Clinical Research Center /ID# 231267
San Jose, California, United States, 95124-4108
Actively Recruiting
14
Pacific Clinical Research Management Group /ID# 231636
Upland, California, United States, 91786
Actively Recruiting
15
Sunwise Clinical Research /ID# 230971
Walnut Creek, California, United States, 94596
Actively Recruiting
16
Amicis Research Center /ID# 272621
Winnetka, California, United States, 91306
Actively Recruiting
17
Children's Hospital Colorado - Aurora /ID# 231879
Aurora, Colorado, United States, 80045
Actively Recruiting
18
IMMUNOe Research Centers /ID# 230879
Centennial, Colorado, United States, 80112
Completed
19
MCB Clinical Research Centers /ID# 231625
Colorado Springs, Colorado, United States, 80910
Completed
20
New England Institute for Clinical Research /ID# 230635
Stamford, Connecticut, United States, 06905
Actively Recruiting
21
Emerson Clinical Research Institute - Washington - Connecticut Avenue /ID# 231693
Washington D.C., District of Columbia, United States, 20009
Actively Recruiting
22
Encore Medical Research of Boynton Beach LLC /ID# 246833
Boynton Beach, Florida, United States, 33436-7245
Actively Recruiting
23
Gulf Coast Clinical Research Center /ID# 230020
Fort Myers, Florida, United States, 33912
Actively Recruiting
24
Sarkis Clinical Trials /ID# 227956
Gainesville, Florida, United States, 32607
Completed
25
Northwest Florida Clinical Research Group, LLC /ID# 231069
Gulf Breeze, Florida, United States, 32561-4495
Completed
26
AGA Clinical Trials /ID# 230554
Hialeah, Florida, United States, 33012
Actively Recruiting
27
Encore Medical Research /ID# 245682
Hollywood, Florida, United States, 33021
Actively Recruiting
28
Advanced Research Institute of Miami /ID# 230292
Homestead, Florida, United States, 33030-4613
Completed
29
Auzmer Research /ID# 239251
Lakeland, Florida, United States, 33813-2768
Completed
30
Columbus Clinical Services, Llc /Id# 230880
Miami, Florida, United States, 33125
Actively Recruiting
31
My Preferred Research LLC /ID# 227886
Miami, Florida, United States, 33155
Actively Recruiting
32
Neurology & Pain Medicine /ID# 240168
Miami, Florida, United States, 33186-7661
Completed
33
Medical Research Group of Central Florida /ID# 231632
Orange City, Florida, United States, 32763
Actively Recruiting
34
Clinical Associates of Orlando, LLC /ID# 272619
Orlando, Florida, United States, 32819
Actively Recruiting
35
Suncoast Clinical Research - Palm Harbor /ID# 229337
Palm Harbor, Florida, United States, 34684
Completed
36
Asclepes Research Centers - Spring Hill /ID# 229815
Spring Hill, Florida, United States, 34609-5692
Actively Recruiting
37
University of South Florida- Neuroscience Institute /ID# 229324
Tampa, Florida, United States, 33613
Actively Recruiting
38
Encore Medical Research - Weston /ID# 246809
Weston, Florida, United States, 33331
Actively Recruiting
39
Pediatric Neurology and Epilepsy Specialists /ID# 229967
Winter Park, Florida, United States, 32789-7111
Actively Recruiting
40
Treken Primary Care /ID# 240586
Atlanta, Georgia, United States, 30315
Completed
41
Rare Disease Research, LLC /ID# 231046
Atlanta, Georgia, United States, 30318-2512
Actively Recruiting
42
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134
Atlanta, Georgia, United States, 30328
Actively Recruiting
43
Coastal Georgia Child Neurology /ID# 231409
Brunswick, Georgia, United States, 31520-1601
Actively Recruiting
44
CenExcel iResearch LLC /ID# 227903
Decatur, Georgia, United States, 30030
Actively Recruiting
45
Velocity Clinical Research - Savannah. /ID# 228992
Savannah, Georgia, United States, 31406
Actively Recruiting
46
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738
Stockbridge, Georgia, United States, 30281
Completed
47
Velocity Clinical Research - Boise /ID# 231871
Meridian, Idaho, United States, 83642
Actively Recruiting
48
Chicago Headache Center & Research Institute /ID# 248625
Chicago, Illinois, United States, 60657
Actively Recruiting
49
Ascension Saint Alexius /ID# 275261
Hoffman Estates, Illinois, United States, 60169
Actively Recruiting
50
Accellacare - McFarland Clinic /ID# 229789
Ames, Iowa, United States, 50010
Actively Recruiting
51
College Park Family Care Center Overland Park /ID# 231456
Overland Park, Kansas, United States, 66210-2761
Completed
52
Clinical Associates Midwest, LLC /ID# 274315
Overland Park, Kansas, United States, 66214
Actively Recruiting
53
Psychiatric Associates /ID# 230872
Overland Park, Kansas, United States, 66221
Completed
54
Alliance for Multispecialty Research - Wichita East /ID# 234126
Wichita, Kansas, United States, 67207
Actively Recruiting
55
University of Kentucky Chandler Medical Center. /ID# 230827
Lexington, Kentucky, United States, 40536
Actively Recruiting
56
Pharmasite Research, Inc. /ID# 227908
Baltimore, Maryland, United States, 21208
Actively Recruiting
57
Minneapolis Clinic of Neurology - Burnsville /ID# 232551
Burnsville, Minnesota, United States, 55337-6732
Actively Recruiting
58
MediSync Clinical Research Hattiesburg Clinic /ID# 233326
Petal, Mississippi, United States, 39465-2932
Completed
59
Proven Endpoints LLC /ID# 239513
Ridgeland, Mississippi, United States, 39157
Actively Recruiting
60
Sharlin Health and Neurology /ID# 229523
Ozark, Missouri, United States, 65721
Actively Recruiting
61
Cognitive Clinical Trials (CCT) - Papillion /ID# 232552
Papillion, Nebraska, United States, 68046-4131
Actively Recruiting
62
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312
Nashua, New Hampshire, United States, 03060-3483
Actively Recruiting
63
Hunterdon Neurology /ID# 245648
Annandale, New Jersey, United States, 08801-3127
Completed
64
Goryeb Childrens Hospital /ID# 229507
Morristown, New Jersey, United States, 07960
Actively Recruiting
65
CVS HealthHUB - Runnemede /ID# 234233
Runnemede, New Jersey, United States, 08078-1034
Completed
66
Dent Neurologic Institute - Amherst /ID# 231182
Amherst, New York, United States, 14226
Actively Recruiting
67
Bioscience Research /ID# 232159
Mount Kisco, New York, United States, 10549-3028
Completed
68
Modern Migraine MD /ID# 258081
New York, New York, United States, 10001
Completed
69
North Suffolk Neurology /ID# 230956
Port Jefferson Station, New York, United States, 11776-3387
Completed
70
SUNY Upstate Medical University /ID# 239898
Syracuse, New York, United States, 13210
Actively Recruiting
71
CVS HealthHUB - Charlotte /ID# 239530
Charlotte, North Carolina, United States, 28210-8905
Completed
72
OnSite Clinical Solutions, LLC - Hickory /ID# 227994
Hickory, North Carolina, United States, 28601
Completed
73
Patient Priority Clinical Sites, LLC /ID# 238485
Cincinnati, Ohio, United States, 45215-2123
Actively Recruiting
74
University Of Cincinnati Medical Center /ID# 231199
Cincinnati, Ohio, United States, 45219
Actively Recruiting
75
Cincinnati Childrens Hospital Medical Center /ID# 244689
Cincinnati, Ohio, United States, 45229
Actively Recruiting
76
Headache Center of Hope /ID# 242645
Cincinnati, Ohio, United States, 45236-1875
Actively Recruiting
77
Centricity Research Columbus /ID# 231181
Columbus, Ohio, United States, 43213
Actively Recruiting
78
CincyScience /ID# 230046
West Chester, Ohio, United States, 45069
Actively Recruiting
79
IPS Research Company /ID# 227961
Oklahoma City, Oklahoma, United States, 73106
Completed
80
Providence Brain and Spine Institute /ID# 231607
Portland, Oregon, United States, 97225-6625
Actively Recruiting
81
Children's Hospital of Philadelphia - Main /ID# 232487
Philadelphia, Pennsylvania, United States, 19104-4319
Actively Recruiting
82
Frontier Clinical Research, LLC - Scottdale /ID# 231913
Scottdale, Pennsylvania, United States, 15683
Actively Recruiting
83
Frontier Clinical Research - Smithfield /ID# 231912
Smithfield, Pennsylvania, United States, 15478
Actively Recruiting
84
Coastal Pediatric Research /ID# 238616
Charleston, South Carolina, United States, 29414-5834
Completed
85
Tribe Clinical Research LLC /ID# 230422
Greenville, South Carolina, United States, 29607-4021
Actively Recruiting
86
Duplicate_Premier Neurology, P.C. /ID# 227999
Greer, South Carolina, United States, 29650
Completed
87
Access Clinical Trials, Inc. /ID# 228002
Nashville, Tennessee, United States, 37203
Actively Recruiting
88
UT Health Austin at Dell Children's Neurology Clinic /ID# 244266
Austin, Texas, United States, 78723-3079
Actively Recruiting
89
Austin Regional Clinic - ARC Four Points /ID# 276301
Austin, Texas, United States, 78726
Actively Recruiting
90
BioBehavioral Research of Austin /ID# 230529
Austin, Texas, United States, 78759
Completed
91
Velocity Clinical Research, Austin /ID# 230557
Austin, Texas, United States, 78759
Actively Recruiting
92
Tekton Research - Beaumont /ID# 231207
Beaumont, Texas, United States, 77706-3067
Actively Recruiting
93
Relaro Medical Trials /ID# 239642
Dallas, Texas, United States, 75243
Actively Recruiting
94
Cedar Health Research /ID# 228003
Dallas, Texas, United States, 75251-2202
Actively Recruiting
95
Epic Medical Research - DeSoto /ID# 274314
DeSoto, Texas, United States, 75115
Actively Recruiting
96
3A Research - East El Paso /ID# 239193
El Paso, Texas, United States, 79925-7945
Completed
97
Earle Research /ID# 231548
Friendswood, Texas, United States, 77546
Completed
98
Innovare Research Group, LLC /ID# 277617
Friendswood, Texas, United States, 77546
Actively Recruiting
99
DM Clinical Research /ID# 229826
Houston, Texas, United States, 77065
Actively Recruiting
100
Aavon Clinical Trials /ID# 279007
Houston, Texas, United States, 77074
Actively Recruiting
101
Houston Clinical Research Associates /ID# 244889
Houston, Texas, United States, 77090-2633
Actively Recruiting
102
Pioneer Research Solutions - Houston - Stancliff Road /ID# 274316
Houston, Texas, United States, 77099
Actively Recruiting
103
Sante Clinical Research /ID# 246503
Kerrville, Texas, United States, 78028-9640
Actively Recruiting
104
FMC Science /ID# 231915
Lampasas, Texas, United States, 76550
Actively Recruiting
105
Livingspring Family Medical Center /ID# 249869
Mansfield, Texas, United States, 76063-5622
Actively Recruiting
106
AIM Trials /ID# 230142
Plano, Texas, United States, 75093
Completed
107
Road Runner Research /ID# 230527
San Antonio, Texas, United States, 78249-3538
Actively Recruiting
108
Family Psychiatry of The Woodlands /ID# 230163
The Woodlands, Texas, United States, 77381
Completed
109
ClinPoint Trials /ID# 230295
Waxahachie, Texas, United States, 75165-1430
Actively Recruiting
110
Pantheon Clinical Research /ID# 250703
Bountiful, Utah, United States, 84010-4968
Actively Recruiting
111
Highland Clinical Research /ID# 239362
Salt Lake City, Utah, United States, 84124
Actively Recruiting
112
University of Utah Health Hospital /ID# 230908
Salt Lake City, Utah, United States, 84132
Completed
113
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976
Woodstock, Vermont, United States, 05091
Completed
114
Office of Maria Ona /ID# 234232
Franklin, Virginia, United States, 23851
Completed
115
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581
Norfolk, Virginia, United States, 23507-1901
Actively Recruiting
116
National Clinical Research /ID# 231320
Richmond, Virginia, United States, 23294
Completed
117
Core Clinical Research /ID# 227904
Everett, Washington, United States, 98201
Actively Recruiting
118
MultiCare Institute for Research & Innovation /ID# 231061
Tacoma, Washington, United States, 98405
Actively Recruiting
119
Frontier Clinical Research - Kingwood /ID# 231914
Kingwood, West Virginia, United States, 26537-9797
Actively Recruiting
120
Mind+ Neurology /ID# 275529
Mequon, Wisconsin, United States, 53092
Actively Recruiting
121
Clinical Research Investigator Group /ID# 267454
Bayamón, Puerto Rico, 00960
Completed
122
Puerto Rico Health Institute /ID# 249162
Dorado, Puerto Rico, 00646
Actively Recruiting
123
GCM Medical Group /ID# 249643
San Juan, Puerto Rico, 00917-3104
Actively Recruiting
124
CMRC Headlands LLC /ID# 265301
San Juan, Puerto Rico, 00918-3501
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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