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, 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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 6 Years to 17 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 months
- Procedures mentioned: Pills, Blood draws, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention."
- "The study duration will be up to 6 months."
- "The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe ubrogepant tablets are and how well they treat migraine attacks in children ages 6–17. In the main study, children get ubrogepant or a placebo, a pill with no study drug. The study lasts up to 6 months.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have had migraines for at least 6 months, with or without aura (warning signs such as vision changes).
- Migraines usually last 3–72 hours without successful treatment, with at least 48 headache-free hours between attacks.
- Had 1–14 migraine attacks with medium to severe pain each month during the 2 months before screening.
- Currently use or have used at least one medicine taken by mouth to treat migraine attacks.
- For the main study, take a placebo for an eligible migraine during screening and report headache pain 2 hours later.
- Weigh at least 44 pounds (20 kg) but less than 135 kg (about 298 pounds).
- Can swallow the study tablets or learn to swallow them.
- Can understand and fill out study forms and an electronic diary. A parent or guardian may help with reading.
Who can't join
- Have a serious medical illness, another pain or mental health condition that could affect the study, cancer within the past 5 years, or a gut condition that could affect how the body uses the drug.
- Have a significant risk of harming yourself or others, recent suicidal intent or behavior, or current alcohol or drug abuse or dependence.
- For the main study, have no headache 2 hours after taking the screening placebo.
- Have chronic migraine (frequent, ongoing migraines), trouble telling migraines from other headaches, certain other headache or nerve pain disorders, or migraines with double vision, reduced awareness, one-sided weakness, or certain eye symptoms.
- Overuse migraine medicines under the study’s rules during the past 3 months, or needed a hospital stay for migraine at least 3 times in the past 6 months. Emergency room visits do not count.
- Need a medicine or food that the study does not allow and cannot stop or switch it.
- Used injected antibodies that block CGRP, a migraine-related pathway, in the past 6 months; or have an allergy or serious reaction to a CGRP-blocking drug or an ingredient in the study pills.
- Are in another study of an experimental drug or device, or took part in one within 30 days before the first visit.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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. 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, 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. * 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
Study sites (125)
AL
- Rehabilitation & Neurological Services /ID# 229969 · Huntsville, AL 35805-4046More trials in Huntsville
- The Center for Clinical Trials - Saraland /ID# 231546 · Saraland, AL 36571More trials in Saraland
AR
- HealthStar Research Glenwood /ID# 275303 · Glenwood, AR 71943Site Coordinator · Study contact · 501-760-2903 · heatherg@healthstarresearch.comMore trials in Glenwood
- HealthStar Research of Hot Springs /ID# 273256 · Hot Springs, AR 71913Site Coordinator · Study contact · 501-760-2903More trials in Hot Springs
- Preferred Research Partners /ID# 230725 · Little Rock, AR 72211More trials in Little Rock
AZ
- Velocity Clinical Research - Phoenix /ID# 274478 · Phoenix, AZ 85006Site Coordinator · Study contact · 602-368-1928 · velocityclinicalphoenix@velocityclinical.comMore trials in Phoenix
CA
- Advanced Research Center /ID# 227962 · Anaheim, CA 92805More trials in Anaheim
- Neuro Pain Research Center /ID# 227966 · Fresno, CA 93710More trials in Fresno
- Imax Clinical Trials /ID# 281436 · La Palma, CA 90623Site Coordinator · Study contact · (714) 735-8100More trials in La Palma
- Alliance for Research Alliance for Wellness /ID# 230546 · Long Beach, CA 90807More trials in Long Beach
- Children's Hospital Los Angeles /ID# 230596 · Los Angeles, CA 90027More trials in Los Angeles
- Paradigm Clinical Research - Modesto, CA /ID# 280611 · Modesto, CA 95355More trials in Modesto
- Excell Research, Inc /ID# 230899 · Oceanside, CA 92056More trials in Oceanside
- Paradigm Clinical Research - San Diego /ID# 269608 · San Diego, CA 92108-1681Site Coordinator · Study contact · 858-274-4226More trials in San Diego
- Lumos Clinical Research Center /ID# 231267 · San Jose, CA 95124-4108More trials in San Jose
- Pacific Clinical Research Management Group /ID# 231636 · Upland, CA 91786More trials in Upland
- Sunwise Clinical Research /ID# 230971 · Walnut Creek, CA 94596More trials in Walnut Creek
- Amicis Research Center /ID# 272621 · Winnetka, CA 91306Site Coordinator · Study contact · 818-924-4708More trials in Winnetka
CO
- Paradigm Clinical Research - Aurora, CO /ID# 280612 · Aurora, CO 80012More trials in Aurora
- Children's Hospital Colorado - Aurora /ID# 231879 · Aurora, CO 80045More trials in Aurora
- IMMUNOe Research Centers /ID# 230879 · Centennial, CO 80112More trials in Centennial
- MCB Clinical Research Centers - Colorado Springs - South Parkside Drive /ID# 231625 · Colorado Springs, CO 80910More trials in Colorado Springs
CT
- New England Institute for Clinical Research /ID# 230635 · Stamford, CT 06905More trials in Stamford
DC
- Emerson Clinical Research Institute - Connecticut Avenue - Washington /ID# 231693 · Washington D.C., DC 20009More trials in Washington D.C.
FL
- Encore Medical Research of Boynton Beach LLC /ID# 246833 · Boynton Beach, FL 33436-7245More trials in Boynton Beach
- Gulf Coast Clinical Research Center /ID# 230020 · Fort Myers, FL 33912More trials in Fort Myers
- Sarkis Clinical Trials /ID# 227956 · Gainesville, FL 32607More trials in Gainesville
- Northwest Florida Clinical Research Group, LLC /ID# 231069 · Gulf Breeze, FL 32561-4495More trials in Gulf Breeze
- AGA Clinical Trials /ID# 230554 · Hialeah, FL 33012More trials in Hialeah
- Encore Medical Research /ID# 245682 · Hollywood, FL 33021Site Coordinator · Study contact · +1-954-400-1725More trials in Hollywood
- Advanced Research Institute of Miami /ID# 230292 · Homestead, FL 33030-4613More trials in Homestead
- Auzmer Research /ID# 239251 · Lakeland, FL 33813-2768More trials in Lakeland
- Columbus Clinical Services, Llc /Id# 230880 · Miami, FL 33125More trials in Miami
- My Preferred Research LLC /ID# 227886 · Miami, FL 33155More trials in Miami
- Neurology & Pain Medicine /ID# 240168 · Miami, FL 33186-7661More trials in Miami
- Medical Research Group of Central Florida /ID# 231632 · Orange City, FL 32763More trials in Orange City
- Clinical Associates of Orlando, LLC /ID# 272619 · Orlando, FL 32819More trials in Orlando
- Suncoast Clinical Research - Palm Harbor /ID# 229337 · Palm Harbor, FL 34684More trials in Palm Harbor
- FWD Clinical Research - Spring Hill /ID# 229815 · Spring Hill, FL 34609-5692More trials in Spring Hill
- University of South Florida- Neuroscience Institute /ID# 229324 · Tampa, FL 33613More trials in Tampa
- Encore Medical Research - Weston /ID# 246809 · Weston, FL 33331More trials in Weston
- Pediatric Neurology and Epilepsy Specialists /ID# 229967 · Winter Park, FL 32789-7111More trials in Winter Park
GA
- Treken Primary Care /ID# 240586 · Atlanta, GA 30315More trials in Atlanta
- Rare Disease Research /ID# 231046 · Atlanta, GA 30318-2512More trials in Atlanta
- Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134 · Atlanta, GA 30328More trials in Atlanta
- Coastal Georgia Child Neurology /ID# 231409 · Brunswick, GA 31520-1601More trials in Brunswick
- CenExcel iResearch LLC /ID# 227903 · Decatur, GA 30030More trials in Decatur
- Velocity Clinical Research - Savannah. /ID# 228992 · Savannah, GA 31406More trials in Savannah
- Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738 · Stockbridge, GA 30281More trials in Stockbridge
IA
- Accellacare - McFarland Clinic /ID# 229789 · Ames, IA 50010More trials in Ames
ID
- Velocity Clinical Research - Boise /ID# 231871 · Meridian, ID 83642More trials in Meridian
IL
- Chicago Headache Center & Research Institute /ID# 248625 · Chicago, IL 60657Site Coordinator · Study contact · (773-935-1000)More trials in Chicago
- Ascension Saint Alexius /ID# 275261 · Hoffman Estates, IL 60169More trials in Hoffman Estates
KS
- College Park Family Care Center Overland Park /ID# 231456 · Overland Park, KS 66210-2761More trials in Overland Park
- Clinical Associates Midwest, LLC /ID# 274315 · Overland Park, KS 66214More trials in Overland Park
- Psychiatric Associates /ID# 230872 · Overland Park, KS 66221More trials in Overland Park
- Alliance For Multispeciality Research - Wichita East /ID# 234126 · Wichita, KS 67207More trials in Wichita
KY
- University of Kentucky Chandler Medical Center /ID# 230827 · Lexington, KY 40536More trials in Lexington
MD
- Pharmasite Research, Inc. /ID# 227908 · Baltimore, MD 21208More trials in Baltimore
MN
- Minneapolis Clinic of Neurology - Burnsville /ID# 232551 · Burnsville, MN 55337-6732More trials in Burnsville
MO
- Sharlin Health and Neurology /ID# 229523 · Ozark, MO 65721More trials in Ozark
MS
- MediSync Clinical Research Hattiesburg Clinic /ID# 233326 · Petal, MS 39465-2932More trials in Petal
- Proven Endpoints LLC /ID# 239513 · Ridgeland, MS 39157More trials in Ridgeland
NC
- CVS HealthHUB - Charlotte /ID# 239530 · Charlotte, NC 28210-8905More trials in Charlotte
- Onsite Clinical Solutions - Don Lochman Lane - Charlotte /ID# 282834 · Charlotte, NC 28277More trials in Charlotte
- OnSite Clinical Solutions - Ninth Ave Drive North East - Hickory /ID# 227994 · Hickory, NC 28601More trials in Hickory
NE
- Cognitive Clinical Trials (CCT) - Papillion /ID# 232552 · Papillion, NE 68046-4131More trials in Papillion
NH
- Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312 · Nashua, NH 03060-3483More trials in Nashua
NJ
- Hunterdon Neurology /ID# 245648 · Annandale, NJ 08801-3127More trials in Annandale
- Goryeb Childrens Hospital /ID# 229507 · Morristown, NJ 07960More trials in Morristown
- CVS HealthHUB - Runnemede /ID# 234233 · Runnemede, NJ 08078-1034More trials in Runnemede
NY
- Dent Neurologic Institute - Amherst /ID# 231182 · Amherst, NY 14226More trials in Amherst
- Duplicate_Bioscience Research /ID# 232159 · Mount Kisco, NY 10549-3028More trials in Mount Kisco
- Modern Migraine MD /ID# 258081 · New York, NY 10001More trials in New York
- North Suffolk Neurology /ID# 230956 · Port Jefferson Station, NY 11776-3387More trials in Port Jefferson Station
- SUNY Upstate Medical University /ID# 239898 · Syracuse, NY 13210More trials in Syracuse
OH
- Patient Priority Clinical Sites, LLC /ID# 238485 · Cincinnati, OH 45215-2123More trials in Cincinnati
- University Of Cincinnati Medical Center /ID# 231199 · Cincinnati, OH 45219More trials in Cincinnati
- Cincinnati Childrens Hospital Medical Center /ID# 244689 · Cincinnati, OH 45229More trials in Cincinnati
- Headache Center of Hope /ID# 242645 · Cincinnati, OH 45236-1875More trials in Cincinnati
- Centricity Research Columbus /ID# 231181 · Columbus, OH 43213Site Coordinator · Study contact · 614 501 6164More trials in Columbus
- CincyScience /ID# 230046 · West Chester, OH 45069More trials in West Chester
OK
- IPS Research Company /ID# 227961 · Oklahoma City, OK 73106More trials in Oklahoma City
OR
- Providence Brain and Spine Institute /ID# 231607 · Portland, OR 97225-6625More trials in Portland
PA
- Children's Hospital of Philadelphia - Main /ID# 232487 · Philadelphia, PA 19104-4319More trials in Philadelphia
- Frontier Clinical Research - Scottdale /ID# 231913 · Scottdale, PA 15683More trials in Scottdale
- Frontier Clinical Research - Smithfield /ID# 231912 · Smithfield, PA 15478More trials in Smithfield
SC
- Coastal Pediatric Research /ID# 238616 · Charleston, SC 29414-5834More trials in Charleston
- Tribe Clinical Research LLC /ID# 230422 · Greenville, SC 29607-4021More trials in Greenville
- Duplicate_Premier Neurology, P.C. /ID# 227999 · Greer, SC 29650More trials in Greer
TN
- Access Clinical Trials, Inc. /ID# 228002 · Nashville, TN 37203More trials in Nashville
TX
- UT Health Austin at Dell Children's Neurology Clinic /ID# 244266 · Austin, TX 78723-3079More trials in Austin
- Austin Regional Clinic - ARC Four Points /ID# 276301 · Austin, TX 78726More trials in Austin
- BioBehavioral Research of Austin /ID# 230529 · Austin, TX 78759More trials in Austin
- Velocity Clinical Research, Austin /ID# 230557 · Austin, TX 78759More trials in Austin
- Tekton Research - Beaumont /ID# 231207 · Beaumont, TX 77706-3067More trials in Beaumont
- Relaro Medical Trials /ID# 239642 · Dallas, TX 75243More trials in Dallas
- Cedar Health Research /ID# 228003 · Dallas, TX 75251-2202More trials in Dallas
- Epic Medical Research - DeSoto /ID# 274314 · DeSoto, TX 75115More trials in DeSoto
- 3A Research - East El Paso /ID# 239193 · El Paso, TX 79925-7945More trials in El Paso
- Earle Research /ID# 231548 · Friendswood, TX 77546More trials in Friendswood
- Innovare Research Group, LLC /ID# 277617 · Friendswood, TX 77546More trials in Friendswood
- DM Clinical Research /ID# 229826 · Houston, TX 77065More trials in Houston
- Aavon Clinical Trials /ID# 279007 · Houston, TX 77074More trials in Houston
- Houston Clinical Research Associates /ID# 244889 · Houston, TX 77090-2633More trials in Houston
- Pioneer Research Solutions - Houston - Stancliff Road /ID# 274316 · Houston, TX 77099More trials in Houston
- Sante Clinical Research /ID# 246503 · Kerrville, TX 78028-9640Site Coordinator · Study contact · 830-890-5171More trials in Kerrville
- FMC Science /ID# 231915 · Lampasas, TX 76550Site Coordinator · Study contact · 512-556-4130More trials in Lampasas
- Livingspring Family Medical Center /ID# 249869 · Mansfield, TX 76063-5622Site Coordinator · Study contact · (817) 907-7330More trials in Mansfield
- AIM Trials /ID# 230142 · Plano, TX 75093More trials in Plano
- Road Runner Research /ID# 230527 · San Antonio, TX 78249-3538More trials in San Antonio
- Family Psychiatry of The Woodlands /ID# 230163 · The Woodlands, TX 77381More trials in The Woodlands
- ClinPoint Trials /ID# 230295 · Waxahachie, TX 75165-1430More trials in Waxahachie
UT
- Pantheon Clinical Research /ID# 250703 · Bountiful, UT 84010-4968More trials in Bountiful
- Highland Clinical Research /ID# 239362 · Salt Lake City, UT 84124More trials in Salt Lake City
- University of Utah Health Hospital /ID# 230908 · Salt Lake City, UT 84132More trials in Salt Lake City
VA
- Pediatric Associates of Charlottesville, PLC /ID# 230628 · Charlottesville, VA 22902More trials in Charlottesville
- Office of Maria Ona /ID# 234232 · Franklin, VA 23851More trials in Franklin
- Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581 · Norfolk, VA 23507-1901More trials in Norfolk
- National Clinical Research /ID# 231320 · Richmond, VA 23294More trials in Richmond
VT
- Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976 · Woodstock, VT 05091More trials in Woodstock
WA
- Core Clinical Research /ID# 227904 · Everett, WA 98201More trials in Everett
- MultiCare Institute for Research and Innovation /ID# 231061 · Tacoma, WA 98405Site Coordinator · Study contact · 253.403.1826 · brittani.higgins@multicare.orgMore trials in Tacoma
WI
- Mind+ Neurology /ID# 275529 · Mequon, WI 53092Site Coordinator · Study contact · (888) 585-7975More trials in Mequon
WV
- Frontier Clinical Research - Kingwood /ID# 231914 · Kingwood, WV 26537-9797More trials in Kingwood