MigrainePhase 3Ubro PedsNCT05125302
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)
A Phase 3 study testing Ubrogepant in people with Migraine, run by AbbVie at 129 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Migraine
- 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
- 1,059 participants
- Where
- 129 sitesin 2 countries
- Study dates
- 13 Jan 2022to May 2027
- Phase
- Phase 3
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD-3) for at least 6 months.
- By history, the participant's migraines typically last between 3 and 72 hours if untreated 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 in each of the 2 months prior to screening (Visit 1).
- Current or past use of at least 1 oral medication (over-the-counter medication or prescription medication) for the acute treatment of migraine.
- For main study participants, treatment of a qualifying migraine with single-blind placebo during the screening period and completion of 2-hour headache pain assessment.
- Weight is ≥ 20 kg (44 pounds) and < 135 kg (298 pounds)
- Per investigator judgment, participant is able to swallow or can learn to swallow study intervention.
- The participant is able to understand and complete the study questionnaires and eDiary. Participants who need assistance with reading the assessments may be assisted by a parent or guardian.
Who cannot join
- Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
- In the opinion of the investigator, other confounding pain syndromes, confounding psychiatric conditions, or other significant neurological disorders other than migraine.
- 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 the study intervention.
- Significant risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others; participants must be excluded if they report suicidal ideation with intent, with or without a plan, (ie, Type 4 or 5 on the C-SSRS) in the past 6 months or report suicidal behavior 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.
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- For main study participants, no headache at the 2-hour post dose assessment after taking 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 or barbiturates > 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 in the 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 of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
- Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (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 be discontinued or switched to an allowable, alternative medication at Visit 1.
- Previous exposure, within the last 6 months, to injectable monoclonal antibodies blocking the calcitonin gene-related peptide (CGRP) pathway
- History of hypersensitivity or clinically significant adverse reaction to a CGRP receptor antagonist or hypersensitivity to any component of the study interventions, ubrogepant or placebo.
- Currently participating or has participated in a study with an investigational compound or device within 30 days prior to Visit 1
Trial locations and contacts
129 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
129 sites in 2 countries
United States125 sites, 88 recruiting
- Recruiting
Accellacare - McFarland Clinic /ID# 229789
Ames, Iowa, 50010
- Recruiting
Dent Neurologic Institute - Amherst /ID# 231182
Amherst, New York, 14226
- Recruiting
Advanced Research Center /ID# 227962
Anaheim, California, 92805
- Completed
Hunterdon Neurology /ID# 245648
Annandale, New Jersey, 08801-3127
- Completed
Treken Primary Care /ID# 240586
Atlanta, Georgia, 30315
- Recruiting
Rare Disease Research /ID# 231046
Atlanta, Georgia, 30318-2512
- Recruiting
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134
Atlanta, Georgia, 30328
- Recruiting
Paradigm Clinical Research - Aurora, CO /ID# 280612
Aurora, Colorado, 80012
- Recruiting
Children's Hospital Colorado - Aurora /ID# 231879
Aurora, Colorado, 80045
- Recruiting
UT Health Austin at Dell Children's Neurology Clinic /ID# 244266
Austin, Texas, 78723-3079
- Recruiting
Austin Regional Clinic - ARC Four Points /ID# 276301
Austin, Texas, 78726
- Completed
BioBehavioral Research of Austin /ID# 230529
Austin, Texas, 78759
- Recruiting
Velocity Clinical Research, Austin /ID# 230557
Austin, Texas, 78759
- Recruiting
Pharmasite Research, Inc. /ID# 227908
Baltimore, Maryland, 21208
- Completed
Tekton Research - Beaumont /ID# 231207
Beaumont, Texas, 77706-3067
- Recruiting
Pantheon Clinical Research /ID# 250703
Bountiful, Utah, 84010-4968
- Recruiting
Encore Medical Research of Boynton Beach LLC /ID# 246833
Boynton Beach, Florida, 33436-7245
- Recruiting
Coastal Georgia Child Neurology /ID# 231409
Brunswick, Georgia, 31520-1601
- Recruiting
Minneapolis Clinic of Neurology - Burnsville /ID# 232551
Burnsville, Minnesota, 55337-6732
- Completed
IMMUNOe Research Centers /ID# 230879
Centennial, Colorado, 80112
- Completed
Coastal Pediatric Research /ID# 238616
Charleston, South Carolina, 29414-5834
- Completed
CVS HealthHUB - Charlotte /ID# 239530
Charlotte, North Carolina, 28210-8905
- Recruiting
Onsite Clinical Solutions - Don Lochman Lane - Charlotte /ID# 282834
Charlotte, North Carolina, 28277
- Recruiting
Pediatric Associates of Charlottesville, PLC /ID# 230628
Charlottesville, Virginia, 22902
- Recruiting
Chicago Headache Center & Research Institute /ID# 248625
Chicago, Illinois, 60657
Site Coordinator, (773-935-1000)
- Recruiting
Patient Priority Clinical Sites, LLC /ID# 238485
Cincinnati, Ohio, 45215-2123
- Recruiting
University Of Cincinnati Medical Center /ID# 231199
Cincinnati, Ohio, 45219
- Recruiting
Cincinnati Childrens Hospital Medical Center /ID# 244689
Cincinnati, Ohio, 45229
- Recruiting
Headache Center of Hope /ID# 242645
Cincinnati, Ohio, 45236-1875
- Completed
MCB Clinical Research Centers - Colorado Springs - South Parkside Drive /ID# 231625
Colorado Springs, Colorado, 80910
- Recruiting
Centricity Research Columbus /ID# 231181
Columbus, Ohio, 43213
Site Coordinator, 614 501 6164
- Recruiting
Relaro Medical Trials /ID# 239642
Dallas, Texas, 75243
- Recruiting
Cedar Health Research /ID# 228003
Dallas, Texas, 75251-2202
- Completed
CenExcel iResearch LLC /ID# 227903
Decatur, Georgia, 30030
- Recruiting
Epic Medical Research - DeSoto /ID# 274314
DeSoto, Texas, 75115
- Completed
3A Research - East El Paso /ID# 239193
El Paso, Texas, 79925-7945
- Recruiting
Core Clinical Research /ID# 227904
Everett, Washington, 98201
- Recruiting
Gulf Coast Clinical Research Center /ID# 230020
Fort Myers, Florida, 33912
- Completed
Office of Maria Ona /ID# 234232
Franklin, Virginia, 23851
- Recruiting
Neuro Pain Research Center /ID# 227966
Fresno, California, 93710
- Completed
Earle Research /ID# 231548
Friendswood, Texas, 77546
- Recruiting
Innovare Research Group, LLC /ID# 277617
Friendswood, Texas, 77546
- Completed
Sarkis Clinical Trials /ID# 227956
Gainesville, Florida, 32607
- Recruiting
HealthStar Research Glenwood /ID# 275303
Glenwood, Arkansas, 71943
Site Coordinator, 501-760-2903, heatherg@healthstarresearch.com
- Recruiting
Tribe Clinical Research LLC /ID# 230422
Greenville, South Carolina, 29607-4021
- Completed
Duplicate_Premier Neurology, P.C. /ID# 227999
Greer, South Carolina, 29650
- Completed
Northwest Florida Clinical Research Group, LLC /ID# 231069
Gulf Breeze, Florida, 32561-4495
- Recruiting
AGA Clinical Trials /ID# 230554
Hialeah, Florida, 33012
- Completed
OnSite Clinical Solutions - Ninth Ave Drive North East - Hickory /ID# 227994
Hickory, North Carolina, 28601
- Recruiting
Ascension Saint Alexius /ID# 275261
Hoffman Estates, Illinois, 60169
- Recruiting
Encore Medical Research /ID# 245682
Hollywood, Florida, 33021
Site Coordinator, +1-954-400-1725
- Completed
Advanced Research Institute of Miami /ID# 230292
Homestead, Florida, 33030-4613
- Recruiting
HealthStar Research of Hot Springs /ID# 273256
Hot Springs, Arkansas, 71913
Site Coordinator, 501-760-2903
- Recruiting
DM Clinical Research /ID# 229826
Houston, Texas, 77065
- Recruiting
Aavon Clinical Trials /ID# 279007
Houston, Texas, 77074
- Recruiting
Houston Clinical Research Associates /ID# 244889
Houston, Texas, 77090-2633
- Recruiting
Pioneer Research Solutions - Houston - Stancliff Road /ID# 274316
Houston, Texas, 77099
- Recruiting
Rehabilitation & Neurological Services /ID# 229969
Huntsville, Alabama, 35805-4046
- Recruiting
Sante Clinical Research /ID# 246503
Kerrville, Texas, 78028-9640
Site Coordinator, 830-890-5171
- Recruiting
Frontier Clinical Research - Kingwood /ID# 231914
Kingwood, West Virginia, 26537-9797
- Recruiting
Imax Clinical Trials /ID# 281436
La Palma, California, 90623
Site Coordinator, (714) 735-8100
- Completed
Auzmer Research /ID# 239251
Lakeland, Florida, 33813-2768
- Recruiting
FMC Science /ID# 231915
Lampasas, Texas, 76550
Site Coordinator, 512-556-4130
- Recruiting
University of Kentucky Chandler Medical Center /ID# 230827
Lexington, Kentucky, 40536
- Recruiting
Preferred Research Partners /ID# 230725
Little Rock, Arkansas, 72211
- Recruiting
Alliance for Research Alliance for Wellness /ID# 230546
Long Beach, California, 90807
- Completed
Children's Hospital Los Angeles /ID# 230596
Los Angeles, California, 90027
- Recruiting
Livingspring Family Medical Center /ID# 249869
Mansfield, Texas, 76063-5622
Site Coordinator, (817) 907-7330
- Recruiting
Mind+ Neurology /ID# 275529
Mequon, Wisconsin, 53092
Site Coordinator, (888) 585-7975
- Recruiting
Velocity Clinical Research - Boise /ID# 231871
Meridian, Idaho, 83642
- Recruiting
Columbus Clinical Services, Llc /Id# 230880
Miami, Florida, 33125
- Recruiting
My Preferred Research LLC /ID# 227886
Miami, Florida, 33155
- Completed
Neurology & Pain Medicine /ID# 240168
Miami, Florida, 33186-7661
- Recruiting
Paradigm Clinical Research - Modesto, CA /ID# 280611
Modesto, California, 95355
- Recruiting
Goryeb Childrens Hospital /ID# 229507
Morristown, New Jersey, 07960
- Completed
Duplicate_Bioscience Research /ID# 232159
Mount Kisco, New York, 10549-3028
- Recruiting
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312
Nashua, New Hampshire, 03060-3483
- Recruiting
Access Clinical Trials, Inc. /ID# 228002
Nashville, Tennessee, 37203
- Completed
Modern Migraine MD /ID# 258081
New York, New York, 10001
- Recruiting
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581
Norfolk, Virginia, 23507-1901
- Recruiting
Excell Research, Inc /ID# 230899
Oceanside, California, 92056
- Completed
IPS Research Company /ID# 227961
Oklahoma City, Oklahoma, 73106
- Recruiting
Medical Research Group of Central Florida /ID# 231632
Orange City, Florida, 32763
- Recruiting
Clinical Associates of Orlando, LLC /ID# 272619
Orlando, Florida, 32819
- Completed
College Park Family Care Center Overland Park /ID# 231456
Overland Park, Kansas, 66210-2761
- Recruiting
Clinical Associates Midwest, LLC /ID# 274315
Overland Park, Kansas, 66214
- Completed
Psychiatric Associates /ID# 230872
Overland Park, Kansas, 66221
- Completed
Sharlin Health and Neurology /ID# 229523
Ozark, Missouri, 65721
- Completed
Suncoast Clinical Research - Palm Harbor /ID# 229337
Palm Harbor, Florida, 34684
- Recruiting
Cognitive Clinical Trials (CCT) - Papillion /ID# 232552
Papillion, Nebraska, 68046-4131
- Completed
MediSync Clinical Research Hattiesburg Clinic /ID# 233326
Petal, Mississippi, 39465-2932
- Recruiting
Children's Hospital of Philadelphia - Main /ID# 232487
Philadelphia, Pennsylvania, 19104-4319
- Recruiting
Velocity Clinical Research - Phoenix /ID# 274478
Phoenix, Arizona, 85006
Site Coordinator, 602-368-1928, velocityclinicalphoenix@velocityclinical.com
- Completed
AIM Trials /ID# 230142
Plano, Texas, 75093
- Completed
North Suffolk Neurology /ID# 230956
Port Jefferson Station, New York, 11776-3387
- Recruiting
Providence Brain and Spine Institute /ID# 231607
Portland, Oregon, 97225-6625
- Completed
National Clinical Research /ID# 231320
Richmond, Virginia, 23294
- Recruiting
Proven Endpoints LLC /ID# 239513
Ridgeland, Mississippi, 39157
- Completed
CVS HealthHUB - Runnemede /ID# 234233
Runnemede, New Jersey, 08078-1034
- Recruiting
Highland Clinical Research /ID# 239362
Salt Lake City, Utah, 84124
- Completed
University of Utah Health Hospital /ID# 230908
Salt Lake City, Utah, 84132
- Recruiting
Road Runner Research /ID# 230527
San Antonio, Texas, 78249-3538
- Recruiting
Paradigm Clinical Research - San Diego /ID# 269608
San Diego, California, 92108-1681
Site Coordinator, 858-274-4226
- Recruiting
Lumos Clinical Research Center /ID# 231267
San Jose, California, 95124-4108
- Recruiting
The Center for Clinical Trials - Saraland /ID# 231546
Saraland, Alabama, 36571
- Recruiting
Velocity Clinical Research - Savannah. /ID# 228992
Savannah, Georgia, 31406
- Recruiting
Frontier Clinical Research - Scottdale /ID# 231913
Scottdale, Pennsylvania, 15683
- Recruiting
Frontier Clinical Research - Smithfield /ID# 231912
Smithfield, Pennsylvania, 15478
- Recruiting
FWD Clinical Research - Spring Hill /ID# 229815
Spring Hill, Florida, 34609-5692
- Recruiting
New England Institute for Clinical Research /ID# 230635
Stamford, Connecticut, 06905
- Completed
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738
Stockbridge, Georgia, 30281
- Recruiting
SUNY Upstate Medical University /ID# 239898
Syracuse, New York, 13210
- Recruiting
MultiCare Institute for Research and Innovation /ID# 231061
Tacoma, Washington, 98405
Site Coordinator, 253.403.1826, brittani.higgins@multicare.org
- Recruiting
University of South Florida- Neuroscience Institute /ID# 229324
Tampa, Florida, 33613
- Completed
Family Psychiatry of The Woodlands /ID# 230163
The Woodlands, Texas, 77381
- Completed
Pacific Clinical Research Management Group /ID# 231636
Upland, California, 91786
- Recruiting
Sunwise Clinical Research /ID# 230971
Walnut Creek, California, 94596
- Recruiting
Emerson Clinical Research Institute - Connecticut Avenue - Washington /ID# 231693
Washington D.C., District of Columbia, 20009
- Recruiting
ClinPoint Trials /ID# 230295
Waxahachie, Texas, 75165-1430
- Recruiting
CincyScience /ID# 230046
West Chester, Ohio, 45069
- Recruiting
Encore Medical Research - Weston /ID# 246809
Weston, Florida, 33331
- Recruiting
Alliance For Multispeciality Research - Wichita East /ID# 234126
Wichita, Kansas, 67207
- Recruiting
Amicis Research Center /ID# 272621
Winnetka, California, 91306
Site Coordinator, 818-924-4708
- Recruiting
Pediatric Neurology and Epilepsy Specialists /ID# 229967
Winter Park, Florida, 32789-7111
- Completed
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976
Woodstock, Vermont, 05091
Puerto Rico4 sites, 3 recruiting
- Completed
Clinical Research Investigator Group /ID# 267454
Bayamón, 00960
- Recruiting
Puerto Rico Health Institute /ID# 249162
Dorado, 00646
Site Coordinator, 787-797-1049
- Recruiting
GCM Medical Group /ID# 249643
San Juan, 00917-3104
Site Coordinator, 787-936-2100
- Recruiting
Caribbean Medical Research Center Headlands /ID# 265301
San Juan, 00918-3501
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
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.
Read more
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
- Migraine
- Being tested
- Ubrogepant, Placebo-Matching Ubrogepant
- Keywords
- Migraine, Ubrogepant, Ubrelvy, PERISCOPE
- 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
Also called Ubrelvy
Oral Tablet
Placebo-Matching UbrogepantDrug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| PK Cohort: Ubrogepant Dose A | Experimental | Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study. Receives: Drug: Ubrogepant |
| PK Cohort: Ubrogepant Dose B | Experimental | Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study. Receives: Drug: Ubrogepant |
| Main Study: Children Ubrogepant Low Dose | Experimental | Participants aged 6 to 11 (after dose selection) will receive oral tablets of low dose ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity. Receives: Drug: Ubrogepant |
| Main Study: Children Ubrogepant High Dose | Experimental | Participants aged 6 to 11 (after dose selection) will receive oral tablets of high dose ubrogepant Dose B for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity. Receives: Drug: Ubrogepant |
| Main Study: Children Ubrogepant Placebo | Placebo comparator | Participants aged 6 to 11 (after dose selection) will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity. Receives: Drug: Placebo-Matching Ubrogepant |
| Main Study: Adolescents Ubrogepant Low Dose | Experimental | Participants aged 12 to 17 will receive oral tablets of ubrogepant low dose for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity. Receives: Drug: Ubrogepant |
| Main Study: Adolescents Ubrogepant High Dose | Experimental | Participants aged 12 to 17 will receive oral tablets of ubrogepant high dose or qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity. Receives: Drug: Ubrogepant |
| Main Study: Adolescents Ubrogepant Placebo | Placebo comparator | Participants aged 12 to 17 will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity. Receives: Drug: Placebo-Matching Ubrogepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.
Measured: 2 hours after initial dose
Secondary outcomes (15)
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years
Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to
Measured: 2 hours after initial dose
Percentage of participants with Pain Relief at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years
Pain Relief is defined as a reduction in headache severity from moderate/severe at baseline to mild or no pain.
Measured: 2 hours after initial dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose in pediatric participants aged 6 to 17 years
Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug.
Measured: 2 to 24 hours after initial dose
Percentage of participants that used rescue medication (including a second dose of study intervention) within 24 hours after the initial dose in pediatric participants aged 6 to 17 years
Measured: 24 hours after initial dose
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose in pediatric participants aged 6 to 17 years
The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'.
Measured: Baseline (Predose) to 2 hours after initial dose
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose in pediatric participants aged 12 to 17 years
The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'.
Measured: Baseline (Predose) to 2 hours after initial dose
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 11 years
Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.
Measured: 2 hours after initial dose
Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Photophobia was defined as sensitivity to light, a migraine-associated symptom.
Measured: 2 hours after initial dose
Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Phonophobia was defined as sensitivity to sound, a migraine-associated symptom.
Measured: 2 hours after initial dose
Percentage of Participants With the Absence of Nausea at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Nausea was a migraine-associated symptom.
Measured: 2 hours after initial dose
Number of Participants with Adverse Events (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to 6 months
Percentage of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed in pediatric participants aged 6 to 17 years
Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Measured: Up to 6 months
Change From Baseline in Electrocardiograms (ECGs) in pediatric participants aged 6 to 17 years
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Measured: Up to 6 months
Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements in pediatric participants aged 6 to 17 years
Percentage of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Measured: Up to 6 months
Percentage of patients with suicidal ideation or suicidal behavior
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start13 Jan 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,059 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125302
- Sponsor's protocol ID
- 3110-305-002
- Acronym
- Ubro Peds
- Status last verified
- Sep 2026
- First submitted
- 8 Nov 2021
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.