Recruiting
Phase 3

Ubrogepant

Sponsor:

AbbVie

Code:

NCT05125302

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Ubrogepant

Placebo-Matching Ubrogepant

Study Details

Brief 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.

Conditions

Migraine

Study ID

NCT05125302

Start date

Jan 13, 2022

Status verified date

Sep, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

1059 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PK Cohort: Ubrogepant Dose A

Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.

experimental: PK Cohort: Ubrogepant Dose B

Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.

experimental: Main Study: Children Ubrogepant Low Dose

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.

experimental: Main Study: Children Ubrogepant High Dose

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.

placebo comparator: Main Study: Children Ubrogepant Placebo

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.

experimental: Main Study: Adolescents Ubrogepant Low Dose

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.

experimental: Main Study: Adolescents Ubrogepant High Dose

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.

placebo comparator: Main Study: Adolescents Ubrogepant Placebo

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.

Interventions

Ubrogepant

Oral Tablet

Placebo-Matching Ubrogepant

Oral Tablet

Primary outcome measure

  • Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years [ Time Frame: 2 hours after initial dose ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Rehabilitation & Neurological Services /ID# 229969

Recruiting

Huntsville, Alabama, United States, 35805-4046

The Center for Clinical Trials - Saraland /ID# 231546

Recruiting

Saraland, Alabama, United States, 36571

Velocity Clinical Research - Phoenix /ID# 274478

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Site Coordinator

602-368-1928velocityclinicalphoenix@velocityclinical.com

HealthStar Research Glenwood /ID# 275303

Recruiting

Glenwood, Arkansas, United States, 71943

Contacts

Site Coordinator

501-760-2903heatherg@healthstarresearch.com

HealthStar Research of Hot Springs /ID# 273256

Recruiting

Hot Springs, Arkansas, United States, 71913

Contacts

Site Coordinator

501-760-2903

Preferred Research Partners /ID# 230725

Recruiting

Little Rock, Arkansas, United States, 72211

Advanced Research Center /ID# 227962

Recruiting

Anaheim, California, United States, 92805

Neuro Pain Research Center /ID# 227966

Recruiting

Fresno, California, United States, 93710

Imax Clinical Trials /ID# 281436

Recruiting

La Palma, California, United States, 90623

Contacts

Site Coordinator

(714) 735-8100

Alliance for Research Alliance for Wellness /ID# 230546

Recruiting

Long Beach, California, United States, 90807

Paradigm Clinical Research - Modesto, CA /ID# 280611

Recruiting

Modesto, California, United States, 95355

Excell Research, Inc /ID# 230899

Recruiting

Oceanside, California, United States, 92056

Paradigm Clinical Research - San Diego /ID# 269608

Recruiting

San Diego, California, United States, 92108-1681

Contacts

Site Coordinator

858-274-4226

Lumos Clinical Research Center /ID# 231267

Recruiting

San Jose, California, United States, 95124-4108

Sunwise Clinical Research /ID# 230971

Recruiting

Walnut Creek, California, United States, 94596

Amicis Research Center /ID# 272621

Recruiting

Winnetka, California, United States, 91306

Contacts

Site Coordinator

818-924-4708

Paradigm Clinical Research - Aurora, CO /ID# 280612

Recruiting

Aurora, Colorado, United States, 80012

Children's Hospital Colorado - Aurora /ID# 231879

Recruiting

Aurora, Colorado, United States, 80045

New England Institute for Clinical Research /ID# 230635

Recruiting

Stamford, Connecticut, United States, 06905

Emerson Clinical Research Institute - Connecticut Avenue - Washington /ID# 231693

Recruiting

Washington D.C., District of Columbia, United States, 20009

Encore Medical Research of Boynton Beach LLC /ID# 246833

Recruiting

Boynton Beach, Florida, United States, 33436-7245

Gulf Coast Clinical Research Center /ID# 230020

Recruiting

Fort Myers, Florida, United States, 33912

AGA Clinical Trials /ID# 230554

Recruiting

Hialeah, Florida, United States, 33012

Encore Medical Research /ID# 245682

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Site Coordinator

+1-954-400-1725

Columbus Clinical Services, Llc /Id# 230880

Recruiting

Miami, Florida, United States, 33125

My Preferred Research LLC /ID# 227886

Recruiting

Miami, Florida, United States, 33155

Medical Research Group of Central Florida /ID# 231632

Recruiting

Orange City, Florida, United States, 32763

Clinical Associates of Orlando, LLC /ID# 272619

Recruiting

Orlando, Florida, United States, 32819

FWD Clinical Research - Spring Hill /ID# 229815

Recruiting

Spring Hill, Florida, United States, 34609-5692

University of South Florida- Neuroscience Institute /ID# 229324

Recruiting

Tampa, Florida, United States, 33613

Encore Medical Research - Weston /ID# 246809

Recruiting

Weston, Florida, United States, 33331

Pediatric Neurology and Epilepsy Specialists /ID# 229967

Recruiting

Winter Park, Florida, United States, 32789-7111

Rare Disease Research /ID# 231046

Recruiting

Atlanta, Georgia, United States, 30318-2512

Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134

Recruiting

Atlanta, Georgia, United States, 30328

Coastal Georgia Child Neurology /ID# 231409

Recruiting

Brunswick, Georgia, United States, 31520-1601

Velocity Clinical Research - Savannah. /ID# 228992

Recruiting

Savannah, Georgia, United States, 31406

Velocity Clinical Research - Boise /ID# 231871

Recruiting

Meridian, Idaho, United States, 83642

Chicago Headache Center & Research Institute /ID# 248625

Recruiting

Chicago, Illinois, United States, 60657

Contacts

Site Coordinator

(773-935-1000)

Ascension Saint Alexius /ID# 275261

Recruiting

Hoffman Estates, Illinois, United States, 60169

Accellacare - McFarland Clinic /ID# 229789

Recruiting

Ames, Iowa, United States, 50010

Clinical Associates Midwest, LLC /ID# 274315

Recruiting

Overland Park, Kansas, United States, 66214

Alliance For Multispeciality Research - Wichita East /ID# 234126

Recruiting

Wichita, Kansas, United States, 67207

University of Kentucky Chandler Medical Center /ID# 230827

Recruiting

Lexington, Kentucky, United States, 40536

Pharmasite Research, Inc. /ID# 227908

Recruiting

Baltimore, Maryland, United States, 21208

Minneapolis Clinic of Neurology - Burnsville /ID# 232551

Recruiting

Burnsville, Minnesota, United States, 55337-6732

Proven Endpoints LLC /ID# 239513

Recruiting

Ridgeland, Mississippi, United States, 39157

Cognitive Clinical Trials (CCT) - Papillion /ID# 232552

Recruiting

Papillion, Nebraska, United States, 68046-4131

Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312

Recruiting

Nashua, New Hampshire, United States, 03060-3483

Goryeb Childrens Hospital /ID# 229507

Recruiting

Morristown, New Jersey, United States, 07960

Dent Neurologic Institute - Amherst /ID# 231182

Recruiting

Amherst, New York, United States, 14226

SUNY Upstate Medical University /ID# 239898

Recruiting

Syracuse, New York, United States, 13210

Onsite Clinical Solutions - Don Lochman Lane - Charlotte /ID# 282834

Recruiting

Charlotte, North Carolina, United States, 28277

Patient Priority Clinical Sites, LLC /ID# 238485

Recruiting

Cincinnati, Ohio, United States, 45215-2123

University Of Cincinnati Medical Center /ID# 231199

Recruiting

Cincinnati, Ohio, United States, 45219

Cincinnati Childrens Hospital Medical Center /ID# 244689

Recruiting

Cincinnati, Ohio, United States, 45229

Headache Center of Hope /ID# 242645

Recruiting

Cincinnati, Ohio, United States, 45236-1875

Centricity Research Columbus /ID# 231181

Recruiting

Columbus, Ohio, United States, 43213

Contacts

Site Coordinator

614 501 6164

CincyScience /ID# 230046

Recruiting

West Chester, Ohio, United States, 45069

Providence Brain and Spine Institute /ID# 231607

Recruiting

Portland, Oregon, United States, 97225-6625

Children's Hospital of Philadelphia - Main /ID# 232487

Recruiting

Philadelphia, Pennsylvania, United States, 19104-4319

Frontier Clinical Research - Scottdale /ID# 231913

Recruiting

Scottdale, Pennsylvania, United States, 15683

Frontier Clinical Research - Smithfield /ID# 231912

Recruiting

Smithfield, Pennsylvania, United States, 15478

Tribe Clinical Research LLC /ID# 230422

Recruiting

Greenville, South Carolina, United States, 29607-4021

Access Clinical Trials, Inc. /ID# 228002

Recruiting

Nashville, Tennessee, United States, 37203

UT Health Austin at Dell Children's Neurology Clinic /ID# 244266

Recruiting

Austin, Texas, United States, 78723-3079

Austin Regional Clinic - ARC Four Points /ID# 276301

Recruiting

Austin, Texas, United States, 78726

Velocity Clinical Research, Austin /ID# 230557

Recruiting

Austin, Texas, United States, 78759

Relaro Medical Trials /ID# 239642

Recruiting

Dallas, Texas, United States, 75243

Cedar Health Research /ID# 228003

Recruiting

Dallas, Texas, United States, 75251-2202

Epic Medical Research - DeSoto /ID# 274314

Recruiting

DeSoto, Texas, United States, 75115

Innovare Research Group, LLC /ID# 277617

Recruiting

Friendswood, Texas, United States, 77546

DM Clinical Research /ID# 229826

Recruiting

Houston, Texas, United States, 77065

Aavon Clinical Trials /ID# 279007

Recruiting

Houston, Texas, United States, 77074

Houston Clinical Research Associates /ID# 244889

Recruiting

Houston, Texas, United States, 77090-2633

Pioneer Research Solutions - Houston - Stancliff Road /ID# 274316

Recruiting

Houston, Texas, United States, 77099

Sante Clinical Research /ID# 246503

Recruiting

Kerrville, Texas, United States, 78028-9640

Contacts

Site Coordinator

830-890-5171

FMC Science /ID# 231915

Recruiting

Lampasas, Texas, United States, 76550

Contacts

Site Coordinator

512-556-4130

Livingspring Family Medical Center /ID# 249869

Recruiting

Mansfield, Texas, United States, 76063-5622

Contacts

Site Coordinator

(817) 907-7330

Road Runner Research /ID# 230527

Recruiting

San Antonio, Texas, United States, 78249-3538

ClinPoint Trials /ID# 230295

Recruiting

Waxahachie, Texas, United States, 75165-1430

Pantheon Clinical Research /ID# 250703

Recruiting

Bountiful, Utah, United States, 84010-4968

Highland Clinical Research /ID# 239362

Recruiting

Salt Lake City, Utah, United States, 84124

Pediatric Associates of Charlottesville, PLC /ID# 230628

Recruiting

Charlottesville, Virginia, United States, 22902

Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581

Recruiting

Norfolk, Virginia, United States, 23507-1901

Core Clinical Research /ID# 227904

Recruiting

Everett, Washington, United States, 98201

MultiCare Institute for Research and Innovation /ID# 231061

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Site Coordinator

253.403.1826brittani.higgins@multicare.org

Frontier Clinical Research - Kingwood /ID# 231914

Recruiting

Kingwood, West Virginia, United States, 26537-9797

Mind+ Neurology /ID# 275529

Recruiting

Mequon, Wisconsin, United States, 53092

Contacts

Site Coordinator

(888) 585-7975

More Information

Sponsor

AbbVie

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • Migraine
  • Ubrogepant
  • Ubrelvy
  • PERISCOPE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.