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RecruitingPhase 3

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)

AbbVie · NCT05125302

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1059
US sites recruiting
88
Study start
January 13, 2022
Record last updated
September 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Ubrogepant; Placebo-Matching Ubrogepant

Conditions: Migraine

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Rehabilitation & Neurological Services /ID# 229969

    Huntsville, AL 35805-4046

  • The Center for Clinical Trials - Saraland /ID# 231546

    Saraland, AL 36571

  • Velocity Clinical Research - Phoenix /ID# 274478

    Phoenix, AZ 85006

    Site contact: Site Coordinator · 602-368-1928 · velocityclinicalphoenix@velocityclinical.com

  • HealthStar Research Glenwood /ID# 275303

    Glenwood, AR 71943

    Site contact: Site Coordinator · 501-760-2903 · heatherg@healthstarresearch.com

  • HealthStar Research of Hot Springs /ID# 273256

    Hot Springs, AR 71913

    Site contact: Site Coordinator · 501-760-2903

  • Preferred Research Partners /ID# 230725

    Little Rock, AR 72211

  • Advanced Research Center /ID# 227962

    Anaheim, CA 92805

  • Neuro Pain Research Center /ID# 227966

    Fresno, CA 93710

  • Imax Clinical Trials /ID# 281436

    La Palma, CA 90623

    Site contact: Site Coordinator · (714) 735-8100

  • Alliance for Research Alliance for Wellness /ID# 230546

    Long Beach, CA 90807

  • Paradigm Clinical Research - Modesto, CA /ID# 280611

    Modesto, CA 95355

  • Excell Research, Inc /ID# 230899

    Oceanside, CA 92056

  • Paradigm Clinical Research - San Diego /ID# 269608

    San Diego, CA 92108-1681

    Site contact: Site Coordinator · 858-274-4226

  • Lumos Clinical Research Center /ID# 231267

    San Jose, CA 95124-4108

  • Sunwise Clinical Research /ID# 230971

    Walnut Creek, CA 94596

  • Amicis Research Center /ID# 272621

    Winnetka, CA 91306

    Site contact: Site Coordinator · 818-924-4708

  • Paradigm Clinical Research - Aurora, CO /ID# 280612

    Aurora, CO 80012

  • Children's Hospital Colorado - Aurora /ID# 231879

    Aurora, CO 80045

  • New England Institute for Clinical Research /ID# 230635

    Stamford, CT 06905

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

    Washington D.C., DC 20009

  • Encore Medical Research of Boynton Beach LLC /ID# 246833

    Boynton Beach, FL 33436-7245

  • Gulf Coast Clinical Research Center /ID# 230020

    Fort Myers, FL 33912

  • AGA Clinical Trials /ID# 230554

    Hialeah, FL 33012

  • Encore Medical Research /ID# 245682

    Hollywood, FL 33021

    Site contact: Site Coordinator · +1-954-400-1725

  • Columbus Clinical Services, Llc /Id# 230880

    Miami, FL 33125

  • My Preferred Research LLC /ID# 227886

    Miami, FL 33155

  • Medical Research Group of Central Florida /ID# 231632

    Orange City, FL 32763

  • Clinical Associates of Orlando, LLC /ID# 272619

    Orlando, FL 32819

  • FWD Clinical Research - Spring Hill /ID# 229815

    Spring Hill, FL 34609-5692

  • University of South Florida- Neuroscience Institute /ID# 229324

    Tampa, FL 33613

  • Encore Medical Research - Weston /ID# 246809

    Weston, FL 33331

  • Pediatric Neurology and Epilepsy Specialists /ID# 229967

    Winter Park, FL 32789-7111

  • Rare Disease Research /ID# 231046

    Atlanta, GA 30318-2512

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

    Atlanta, GA 30328

  • Coastal Georgia Child Neurology /ID# 231409

    Brunswick, GA 31520-1601

  • Velocity Clinical Research - Savannah. /ID# 228992

    Savannah, GA 31406

  • Velocity Clinical Research - Boise /ID# 231871

    Meridian, ID 83642

  • Chicago Headache Center & Research Institute /ID# 248625

    Chicago, IL 60657

    Site contact: Site Coordinator · (773-935-1000)

  • Ascension Saint Alexius /ID# 275261

    Hoffman Estates, IL 60169

  • Accellacare - McFarland Clinic /ID# 229789

    Ames, IA 50010

  • Clinical Associates Midwest, LLC /ID# 274315

    Overland Park, KS 66214

  • Alliance For Multispeciality Research - Wichita East /ID# 234126

    Wichita, KS 67207

  • University of Kentucky Chandler Medical Center /ID# 230827

    Lexington, KY 40536

  • Pharmasite Research, Inc. /ID# 227908

    Baltimore, MD 21208

  • Minneapolis Clinic of Neurology - Burnsville /ID# 232551

    Burnsville, MN 55337-6732

  • Proven Endpoints LLC /ID# 239513

    Ridgeland, MS 39157

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

    Papillion, NE 68046-4131

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

    Nashua, NH 03060-3483

  • Goryeb Childrens Hospital /ID# 229507

    Morristown, NJ 07960

  • Dent Neurologic Institute - Amherst /ID# 231182

    Amherst, NY 14226

  • SUNY Upstate Medical University /ID# 239898

    Syracuse, NY 13210

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

    Charlotte, NC 28277

  • Patient Priority Clinical Sites, LLC /ID# 238485

    Cincinnati, OH 45215-2123

  • University Of Cincinnati Medical Center /ID# 231199

    Cincinnati, OH 45219

  • Cincinnati Childrens Hospital Medical Center /ID# 244689

    Cincinnati, OH 45229

  • Headache Center of Hope /ID# 242645

    Cincinnati, OH 45236-1875

  • Centricity Research Columbus /ID# 231181

    Columbus, OH 43213

    Site contact: Site Coordinator · 614 501 6164

  • CincyScience /ID# 230046

    West Chester, OH 45069

  • Providence Brain and Spine Institute /ID# 231607

    Portland, OR 97225-6625

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

    Philadelphia, PA 19104-4319

+ 28 more on the official record.

Study contacts (from the official record)

  • ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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Study to Assess Adverse Events and Disease Activity of Oral… (NCT05125302) | Bored Studies