Actively Recruiting
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Oral Ubrogepant for Acute Migraine Treatment in Children and Adolescents Ages 6 to 17
Led by AbbVie · Updated on 2026-06-05
1059
Participants Needed
129
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Migraine is a common neurological disorder characterized by moderate to severe throbbing headaches often accompanied by nausea, vomiting, and sensitivity to light and sound. This research aims to evaluate the safety and effectiveness of ubrogepant, a drug approved for adults, in treating acute migraine attacks in children and adolescents aged 6 to 17 years. The study includes two participant groups: a pharmacokinetic (PK) cohort and a main study cohort. Children aged 6 to 11 in the PK cohort will receive one of two doses of oral ubrogepant to help determine the appropriate dosing for the main study. In the main study, children aged 6 to 11 will be randomly assigned to receive either a low dose, high dose of ubrogepant, or a placebo, with a one in three chance of placebo assignment. Adolescents aged 12 to 17 will also be randomized to receive low dose, high dose, or placebo. Participants will take oral tablets for qualifying migraine attacks, with the option to take a second dose or rescue medication at least two hours after the first dose if their headache remains moderate or severe. Participants will attend regular hospital or clinic visits over a study period of up to six months. Researchers will monitor treatment effects through medical assessments, blood tests, side effect checks, and questionnaires. The main outcome measured is the percentage of participants who achieve pain freedom two hours after the initial dose. Safety and tolerability will also be assessed throughout the study, including laboratory tests, electrocardiograms, vital sign measurements, and monitoring for suicidal ideation or behavior.
CONDITIONS
Brief 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 ICHD-3
- Migraines usually last 3 to 72 hours if untreated or unsuccessfully treated
- 1 to 14 migraine attacks per month with moderate to severe headache in the 2 months before screening
- Current or past use of at least one oral medication for acute migraine treatment
- For main study, completed treatment of a qualifying migraine with single-blind placebo during screening and 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 eDiary, with assistance if needed
You will not qualify if you...
- Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease
- Other confounding pain syndromes, psychiatric conditions, or neurological disorders besides migraine
- History of malignancy in the 5 years before screening
- Prior gastrointestinal conditions affecting drug absorption or metabolism
- Significant risk of self-harm or harm to others based on clinical interview and Columbia-Suicide Severity Rating Scale
- Current alcohol or drug abuse or dependence
- Placebo responders during screening (no headache at 2 hours post single-blind placebo dose)
- Current diagnosis of chronic migraine
- Overuse of migraine medications as defined by specific frequency limits in past 3 months
- Difficulty distinguishing migraine from other headaches
- History of certain migraine types (aura with diplopia, hemiplegic, retinal) or other headache disorders
- Required in-hospital migraine treatment 3 or more times in 6 months before screening
- Use of prohibited medications or diets that cannot be changed at screening
- Exposure to injectable CGRP pathway-blocking monoclonal antibodies within last 6 months
- History of hypersensitivity to CGRP receptor antagonists or study drugs
- Participation in other investigational studies within 30 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Duration of qualifying migraine attacks during the study period
Participants receive oral tablets of ubrogepant or placebo to treat qualifying migraine attacks. They may take a second dose or rescue medication starting 2 hours after the initial dose if needed.
Visits occur as needed for qualifying migraine attacks
Duration - Up to 6 months
Participants are monitored for safety and adverse events for up to 6 months after treatment.
Periodic safety assessments during follow-up
Trial Site Locations
Total: 129 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
Rezen Clinical Trials /ID# 282831
Glendale, Arizona, United States, 85306
Not Yet Recruiting
4
Velocity Clinical Research - Phoenix /ID# 274478
Phoenix, Arizona, United States, 85006
Actively Recruiting
5
HealthStar Research Glenwood /ID# 275303
Glenwood, Arkansas, United States, 71943
Actively Recruiting
6
HealthStar Research of Hot Springs /ID# 273256
Hot Springs, Arkansas, United States, 71913
Actively Recruiting
7
Preferred Research Partners /ID# 230725
Little Rock, Arkansas, United States, 72211
Actively Recruiting
8
Advanced Research Center /ID# 227962
Anaheim, California, United States, 92805
Actively Recruiting
9
Neuro Pain Research Center /ID# 227966
Fresno, California, United States, 93710
Actively Recruiting
10
Alliance for Research Alliance for Wellness /ID# 230546
Long Beach, California, United States, 90807
Actively Recruiting
11
Children's Hospital Los Angeles /ID# 230596
Los Angeles, California, United States, 90027
Completed
12
Excell Research, Inc /ID# 230899
Oceanside, California, United States, 92056
Actively Recruiting
13
Paradigm Clinical Research - San Diego /ID# 269608
San Diego, California, United States, 92108-1681
Actively Recruiting
14
Lumos Clinical Research Center /ID# 231267
San Jose, California, United States, 95124-4108
Actively Recruiting
15
Pacific Clinical Research Management Group /ID# 231636
Upland, California, United States, 91786
Completed
16
Sunwise Clinical Research /ID# 230971
Walnut Creek, California, United States, 94596
Actively Recruiting
17
Amicis Research Center /ID# 272621
Winnetka, California, United States, 91306
Actively Recruiting
18
Children's Hospital Colorado - Aurora /ID# 231879
Aurora, Colorado, United States, 80045
Actively Recruiting
19
IMMUNOe Research Centers /ID# 230879
Centennial, Colorado, United States, 80112
Completed
20
MCB Clinical Research Centers /ID# 231625
Colorado Springs, Colorado, United States, 80910
Completed
21
New England Institute for Clinical Research /ID# 230635
Stamford, Connecticut, United States, 06905
Actively Recruiting
22
Emerson Clinical Research Institute - Connecticut Avenue - Washington /ID# 231693
Washington D.C., District of Columbia, United States, 20009
Actively Recruiting
23
Encore Medical Research of Boynton Beach LLC /ID# 246833
Boynton Beach, Florida, United States, 33436-7245
Actively Recruiting
24
Gulf Coast Clinical Research Center /ID# 230020
Fort Myers, Florida, United States, 33912
Actively Recruiting
25
Sarkis Clinical Trials /ID# 227956
Gainesville, Florida, United States, 32607
Completed
26
Northwest Florida Clinical Research Group, LLC /ID# 231069
Gulf Breeze, Florida, United States, 32561-4495
Completed
27
AGA Clinical Trials /ID# 230554
Hialeah, Florida, United States, 33012
Actively Recruiting
28
Encore Medical Research /ID# 245682
Hollywood, Florida, United States, 33021
Actively Recruiting
29
Advanced Research Institute of Miami /ID# 230292
Homestead, Florida, United States, 33030-4613
Completed
30
Auzmer Research /ID# 239251
Lakeland, Florida, United States, 33813-2768
Completed
31
Columbus Clinical Services, Llc /Id# 230880
Miami, Florida, United States, 33125
Actively Recruiting
32
My Preferred Research LLC /ID# 227886
Miami, Florida, United States, 33155
Actively Recruiting
33
Neurology & Pain Medicine /ID# 240168
Miami, Florida, United States, 33186-7661
Completed
34
Medical Research Group of Central Florida /ID# 231632
Orange City, Florida, United States, 32763
Actively Recruiting
35
Clinical Associates of Orlando, LLC /ID# 272619
Orlando, Florida, United States, 32819
Actively Recruiting
36
Suncoast Clinical Research - Palm Harbor /ID# 229337
Palm Harbor, Florida, United States, 34684
Completed
37
Asclepes Research Centers - Spring Hill /ID# 229815
Spring Hill, Florida, United States, 34609-5692
Actively Recruiting
38
University of South Florida- Neuroscience Institute /ID# 229324
Tampa, Florida, United States, 33613
Actively Recruiting
39
Encore Medical Research - Weston /ID# 246809
Weston, Florida, United States, 33331
Actively Recruiting
40
Pediatric Neurology and Epilepsy Specialists /ID# 229967
Winter Park, Florida, United States, 32789-7111
Actively Recruiting
41
Treken Primary Care /ID# 240586
Atlanta, Georgia, United States, 30315
Completed
42
Rare Disease Research /ID# 231046
Atlanta, Georgia, United States, 30318-2512
Actively Recruiting
43
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134
Atlanta, Georgia, United States, 30328
Actively Recruiting
44
Coastal Georgia Child Neurology /ID# 231409
Brunswick, Georgia, United States, 31520-1601
Actively Recruiting
45
CenExcel iResearch LLC /ID# 227903
Decatur, Georgia, United States, 30030
Actively Recruiting
46
Velocity Clinical Research - Savannah. /ID# 228992
Savannah, Georgia, United States, 31406
Actively Recruiting
47
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738
Stockbridge, Georgia, United States, 30281
Completed
48
Velocity Clinical Research - Boise /ID# 231871
Meridian, Idaho, United States, 83642
Actively Recruiting
49
Chicago Headache Center & Research Institute /ID# 248625
Chicago, Illinois, United States, 60657
Actively Recruiting
50
Ascension Saint Alexius /ID# 275261
Hoffman Estates, Illinois, United States, 60169
Actively Recruiting
51
Accellacare - McFarland Clinic /ID# 229789
Ames, Iowa, United States, 50010
Actively Recruiting
52
MercyOne Northeast Iowa Family Medicine & Residency /ID# 282810
Waterloo, Iowa, United States, 50702
Not Yet Recruiting
53
College Park Family Care Center Overland Park /ID# 231456
Overland Park, Kansas, United States, 66210-2761
Completed
54
Clinical Associates Midwest, LLC /ID# 274315
Overland Park, Kansas, United States, 66214
Actively Recruiting
55
Psychiatric Associates /ID# 230872
Overland Park, Kansas, United States, 66221
Completed
56
Alliance for Multispecialty Research - Wichita East /ID# 234126
Wichita, Kansas, United States, 67207
Actively Recruiting
57
University of Kentucky Chandler Medical Center. /ID# 230827
Lexington, Kentucky, United States, 40536
Actively Recruiting
58
Pharmasite Research, Inc. /ID# 227908
Baltimore, Maryland, United States, 21208
Actively Recruiting
59
Minneapolis Clinic of Neurology - Burnsville /ID# 232551
Burnsville, Minnesota, United States, 55337-6732
Actively Recruiting
60
MediSync Clinical Research Hattiesburg Clinic /ID# 233326
Petal, Mississippi, United States, 39465-2932
Completed
61
Proven Endpoints LLC /ID# 239513
Ridgeland, Mississippi, United States, 39157
Actively Recruiting
62
Sharlin Health and Neurology /ID# 229523
Ozark, Missouri, United States, 65721
Actively Recruiting
63
Cognitive Clinical Trials (CCT) - Papillion /ID# 232552
Papillion, Nebraska, United States, 68046-4131
Actively Recruiting
64
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312
Nashua, New Hampshire, United States, 03060-3483
Actively Recruiting
65
Hunterdon Neurology /ID# 245648
Annandale, New Jersey, United States, 08801-3127
Completed
66
Goryeb Childrens Hospital /ID# 229507
Morristown, New Jersey, United States, 07960
Actively Recruiting
67
CVS HealthHUB - Runnemede /ID# 234233
Runnemede, New Jersey, United States, 08078-1034
Completed
68
Dent Neurologic Institute - Amherst /ID# 231182
Amherst, New York, United States, 14226
Actively Recruiting
69
Bioscience Research /ID# 232159
Mount Kisco, New York, United States, 10549-3028
Completed
70
Modern Migraine MD /ID# 258081
New York, New York, United States, 10001
Completed
71
North Suffolk Neurology /ID# 230956
Port Jefferson Station, New York, United States, 11776-3387
Completed
72
Hawthorne Health - Staten Island /ID# 283144
Staten Island, New York, United States, 10309
Not Yet Recruiting
73
SUNY Upstate Medical University /ID# 239898
Syracuse, New York, United States, 13210
Actively Recruiting
74
CVS HealthHUB - Charlotte /ID# 239530
Charlotte, North Carolina, United States, 28210-8905
Completed
75
OnSite Clinical Solutions - Ninth Ave Drive North East - Hickory /ID# 227994
Hickory, North Carolina, United States, 28601
Completed
76
Patient Priority Clinical Sites, LLC /ID# 238485
Cincinnati, Ohio, United States, 45215-2123
Actively Recruiting
77
University Of Cincinnati Medical Center /ID# 231199
Cincinnati, Ohio, United States, 45219
Actively Recruiting
78
Cincinnati Childrens Hospital Medical Center /ID# 244689
Cincinnati, Ohio, United States, 45229
Actively Recruiting
79
Headache Center of Hope /ID# 242645
Cincinnati, Ohio, United States, 45236-1875
Actively Recruiting
80
Centricity Research Columbus /ID# 231181
Columbus, Ohio, United States, 43213
Actively Recruiting
81
CincyScience /ID# 230046
West Chester, Ohio, United States, 45069
Actively Recruiting
82
IPS Research Company /ID# 227961
Oklahoma City, Oklahoma, United States, 73106
Completed
83
Providence Brain and Spine Institute /ID# 231607
Portland, Oregon, United States, 97225-6625
Actively Recruiting
84
Hawthorne Health - Horsham /ID# 283151
Horsham, Pennsylvania, United States, 19044
Not Yet Recruiting
85
Children's Hospital of Philadelphia - Main /ID# 232487
Philadelphia, Pennsylvania, United States, 19104-4319
Actively Recruiting
86
Frontier Clinical Research - Scottdale /ID# 231913
Scottdale, Pennsylvania, United States, 15683
Actively Recruiting
87
Frontier Clinical Research - Smithfield /ID# 231912
Smithfield, Pennsylvania, United States, 15478
Actively Recruiting
88
Coastal Pediatric Research /ID# 238616
Charleston, South Carolina, United States, 29414-5834
Completed
89
Tribe Clinical Research LLC /ID# 230422
Greenville, South Carolina, United States, 29607-4021
Actively Recruiting
90
Duplicate_Premier Neurology, P.C. /ID# 227999
Greer, South Carolina, United States, 29650
Completed
91
Hawthorne Health - Lebanon /ID# 283149
Lebanon, Tennessee, United States, 37087
Not Yet Recruiting
92
Access Clinical Trials, Inc. /ID# 228002
Nashville, Tennessee, United States, 37203
Actively Recruiting
93
UT Health Austin at Dell Children's Neurology Clinic /ID# 244266
Austin, Texas, United States, 78723-3079
Actively Recruiting
94
Austin Regional Clinic - ARC Four Points /ID# 276301
Austin, Texas, United States, 78726
Actively Recruiting
95
BioBehavioral Research of Austin /ID# 230529
Austin, Texas, United States, 78759
Completed
96
Velocity Clinical Research, Austin /ID# 230557
Austin, Texas, United States, 78759
Actively Recruiting
97
Tekton Research - Beaumont /ID# 231207
Beaumont, Texas, United States, 77706-3067
Actively Recruiting
98
Relaro Medical Trials /ID# 239642
Dallas, Texas, United States, 75243
Actively Recruiting
99
Cedar Health Research /ID# 228003
Dallas, Texas, United States, 75251-2202
Actively Recruiting
100
Epic Medical Research - DeSoto /ID# 274314
DeSoto, Texas, United States, 75115
Actively Recruiting
101
3A Research - East El Paso /ID# 239193
El Paso, Texas, United States, 79925-7945
Completed
102
Earle Research /ID# 231548
Friendswood, Texas, United States, 77546
Completed
103
Innovare Research Group, LLC /ID# 277617
Friendswood, Texas, United States, 77546
Actively Recruiting
104
DM Clinical Research /ID# 229826
Houston, Texas, United States, 77065
Actively Recruiting
105
Aavon Clinical Trials /ID# 279007
Houston, Texas, United States, 77074
Actively Recruiting
106
Houston Clinical Research Associates /ID# 244889
Houston, Texas, United States, 77090-2633
Actively Recruiting
107
Pioneer Research Solutions - Houston - Stancliff Road /ID# 274316
Houston, Texas, United States, 77099
Actively Recruiting
108
Sante Clinical Research /ID# 246503
Kerrville, Texas, United States, 78028-9640
Actively Recruiting
109
FMC Science /ID# 231915
Lampasas, Texas, United States, 76550
Actively Recruiting
110
Livingspring Family Medical Center /ID# 249869
Mansfield, Texas, United States, 76063-5622
Actively Recruiting
111
AIM Trials /ID# 230142
Plano, Texas, United States, 75093
Completed
112
Road Runner Research /ID# 230527
San Antonio, Texas, United States, 78249-3538
Actively Recruiting
113
Family Psychiatry of The Woodlands /ID# 230163
The Woodlands, Texas, United States, 77381
Completed
114
ClinPoint Trials /ID# 230295
Waxahachie, Texas, United States, 75165-1430
Actively Recruiting
115
Pantheon Clinical Research /ID# 250703
Bountiful, Utah, United States, 84010-4968
Actively Recruiting
116
Highland Clinical Research /ID# 239362
Salt Lake City, Utah, United States, 84124
Actively Recruiting
117
University of Utah Health Hospital /ID# 230908
Salt Lake City, Utah, United States, 84132
Completed
118
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976
Woodstock, Vermont, United States, 05091
Completed
119
Office of Maria Ona /ID# 234232
Franklin, Virginia, United States, 23851
Completed
120
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581
Norfolk, Virginia, United States, 23507-1901
Actively Recruiting
121
National Clinical Research /ID# 231320
Richmond, Virginia, United States, 23294
Completed
122
Core Clinical Research /ID# 227904
Everett, Washington, United States, 98201
Actively Recruiting
123
MultiCare Institute for Research and Innovation /ID# 231061
Tacoma, Washington, United States, 98405
Actively Recruiting
124
Frontier Clinical Research - Kingwood /ID# 231914
Kingwood, West Virginia, United States, 26537-9797
Actively Recruiting
125
Mind+ Neurology /ID# 275529
Mequon, Wisconsin, United States, 53092
Actively Recruiting
126
Clinical Research Investigator Group /ID# 267454
Bayamón, Puerto Rico, 00960
Completed
127
Puerto Rico Health Institute /ID# 249162
Dorado, Puerto Rico, 00646
Actively Recruiting
128
GCM Medical Group /ID# 249643
San Juan, Puerto Rico, 00917-3104
Actively Recruiting
129
CMRC Headlands LLC /ID# 265301
San Juan, Puerto Rico, 00918-3501
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
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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