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)

Purpose

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.

Condition

  • Migraine

Eligibility

Eligible Ages
Between 6 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Ubrogepant
    Oral Tablet
    Other names:
    • Ubrelvy
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.
  • Drug: Ubrogepant
    Oral Tablet
    Other names:
    • Ubrelvy
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.
  • Drug: Ubrogepant
    Oral Tablet
    Other names:
    • Ubrelvy
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.
  • Drug: Ubrogepant
    Oral Tablet
    Other names:
    • Ubrelvy
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.
  • Drug: Placebo-Matching Ubrogepant
    Oral Tablet
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.
  • Drug: Ubrogepant
    Oral Tablet
    Other names:
    • Ubrelvy
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.
  • Drug: Ubrogepant
    Oral Tablet
    Other names:
    • Ubrelvy
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.
  • Drug: Placebo-Matching Ubrogepant
    Oral Tablet

Recruiting Locations

Rehabilitation & Neurological Services /ID# 229969
Huntsville, Alabama 35805-4046

The Center for Clinical Trials - Saraland /ID# 231546
Saraland, Alabama 36571

Preferred Research Partners /ID# 230725
Little Rock, Arkansas 72211

Advanced Research Center /ID# 227962
Anaheim, California 92805

Neuro Pain Medical Center /ID# 227966
Fresno, California 93710-5473

Alliance for Research Alliance for Wellness /ID# 230546
Long Beach, California 90807

Excell Research, Inc /ID# 230899
Oceanside, California 92056

Paradigm Clinical Research - San Diego /ID# 269608
San Diego, California 92108-1681
Contact:
Site Coordinator
858-274-4226

Lumos Clinical Research Center /ID# 231267
San Jose, California 95124-4108

Pacific Clinical Research Management Group /ID# 231636
Upland, California 91786

Sunwise Clinical Research /ID# 230971
Walnut Creek, California 94596

Children's Hospital Colorado - Aurora /ID# 231879
Aurora, Colorado 80045

New England Institute for Clinical Research /ID# 230635
Stamford, Connecticut 06905

Emerson Clinical Research Inst /ID# 231693
Washington, District of Columbia 20011

Encore Medical Research of Boynton Beach LLC /ID# 246833
Boynton Beach, Florida 33436-7245

Gulf Coast Clinical Research Center /ID# 230020
Fort Myers, Florida 33912

A.G.A Clinical Trials /ID# 230554
Hialeah, Florida 33012

Encore Medical Research /ID# 245682
Hollywood, Florida 33021
Contact:
Site Coordinator
+1-954-400-1725

Advanced Research Institute of Miami /ID# 230292
Homestead, Florida 33030-4613

Auzmer Research /ID# 239251
Lakeland, Florida 33813-2768

Columbus Clinical Services, Llc /Id# 230880
Miami, Florida 33125-5114

My Preferred Research LLC /ID# 227886
Miami, Florida 33155

Medical Research Group of Central Florida /ID# 231632
Orange City, Florida 32763

Clinical Associates of Orlando, LLC /ID# 272619
Orlando, Florida 32819

Suncoast Clinical Research - Palm Harbor /ID# 229337
Palm Harbor, Florida 34684

Asclepes Research Centers - Spring Hill /ID# 229815
Spring Hill, Florida 34609-5692

University of South Florida- Neuroscience Institute /ID# 229324
Tampa, Florida 33613

Encore Medical Research - Weston /ID# 246809
Weston, Florida 33331

Pediatric Neurology and Epilepsy Specialists /ID# 229967
Winter Park, Florida 32789-7111

Rare Disease Research, LLC /ID# 231046
Atlanta, Georgia 30318-2512

Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134
Atlanta, Georgia 30328

Coastal Georgia Child Neurology /ID# 231409
Brunswick, Georgia 31520-1601

CenExcel iResearch LLC /ID# 227903
Decatur, Georgia 30030

Velocity Clinical Research - Savannah /ID# 228992
Savannah, Georgia 31406

Velocity Clinical Research - Boise /ID# 231871
Meridian, Idaho 83642

Chicago Headache Center & Research Institute /ID# 248625
Chicago, Illinois 60657
Contact:
Site Coordinator
(773-935-1000)

Accellacare - McFarland Clinic /ID# 229789
Ames, Iowa 50010

Alliance for Multispecialty Research (AMR) - Wichita West /ID# 234126
Wichita, Kansas 67205-1138

University of Kentucky Chandler Medical Center /ID# 230827
Lexington, Kentucky 40536

Pharmasite Research, Inc. /ID# 227908
Baltimore, Maryland 21208

Minneapolis Clinic of Neurology - Burnsville /ID# 232551
Burnsville, Minnesota 55337-6732

Proven Endpoints LLC /ID# 239513
Ridgeland, Mississippi 39157

Sharlin Health Neuroscience Research Center /ID# 229523
Ozark, Missouri 65721-5315

Cognitive Clinical Trials (CCT) - Papillion /ID# 232552
Papillion, Nebraska 68046-4131

Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312
Nashua, New Hampshire 03060-3483

Goryeb Children's Hospital /ID# 229507
Morristown, New Jersey 07960

Dent Neurologic Institute - Amherst /ID# 231182
Amherst, New York 14226

Bioscience Research /ID# 232159
Mount Kisco, New York 10549-3028

Modern Migraine MD /ID# 258081
New York, New York 10001

SUNY Upstate Medical University /ID# 239898
Syracuse, New York 13210

Patient Priority Clinical Sites, LLC /ID# 238485
Cincinnati, Ohio 45215-2123

University Of Cincinnati Medical Center /ID# 231199
Cincinnati, Ohio 45219

Cincinnati Childrens Hospital Medical Center /ID# 244689
Cincinnati, Ohio 45229

Headache Center of Hope /ID# 242645
Cincinnati, Ohio 45236-1875

Centricity Research Columbus /ID# 231181
Columbus, Ohio 43213
Contact:
Site Coordinator
614 501 6164

CincyScience /ID# 230046
West Chester, Ohio 45069

Providence Brain and Spine Institute /ID# 231607
Portland, Oregon 97225-6625

Children's Hospital of Philadelphia - Main /ID# 232487
Philadelphia, Pennsylvania 19104-4319

Frontier Clinical Research, LLC - Scottdale /ID# 231913
Scottdale, Pennsylvania 15683

Frontier Clinical Research /ID# 231912
Smithfield, Pennsylvania 15478

Coastal Pediatric Research /ID# 238616
Charleston, South Carolina 29414-5834

Tribe Clinical Research LLC /ID# 230422
Greenville, South Carolina 29607-4021

Access Clinical Trials, Inc. /ID# 228002
Nashville, Tennessee 37203

UT Health Austin at Dell Children's Neurology Clinic /ID# 244266
Austin, Texas 78723-3079

Velocity Clinical Research, Austin /ID# 230557
Austin, Texas 78759

Tekton Research - Beaumont /ID# 231207
Beaumont, Texas 77706-3067

Relaro Medical Trials /ID# 239642
Dallas, Texas 75243

Cedar Health Research /ID# 228003
Dallas, Texas 75251-2202

3A Research - East El Paso /ID# 239193
El Paso, Texas 79925-7945

DM Clinical Research /ID# 229826
Houston, Texas 77065

Houston Clinical Research Associates /ID# 244889
Houston, Texas 77090-2633

Sante Clinical Research /ID# 246503
Kerrville, Texas 78028-9640
Contact:
Site Coordinator
830-890-5171

FMC Science /ID# 231915
Lampasas, Texas 76550
Contact:
Site Coordinator
512-556-4130

Livingspring Family Medical Center /ID# 249869
Mansfield, Texas 76063-5622
Contact:
Site Coordinator
(817) 907-7330

AIM Trials /ID# 230142
Plano, Texas 75093

Road Runner Research /ID# 230527
San Antonio, Texas 78249-3538

Family Psychiatry of The Woodlands /ID# 230163
The Woodlands, Texas 77381

ClinPoint Trials /ID# 230295
Waxahachie, Texas 75165-1430

Pantheon Clinical Research /ID# 250703
Bountiful, Utah 84010-4968

Highland Clinical Research /ID# 239362
Salt Lake City, Utah 84124

Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581
Norfolk, Virginia 23507-1901

Core Clinical Research /ID# 227904
Everett, Washington 98201

Frontier Clinical Research - Kingwood /ID# 231914
Kingwood, West Virginia 26537-9797

Clinical Research Investigator Group, LLC /ID# 267454
Bayamon, Puerto Rico 00960

Puerto Rico Health Institute /ID# 249162
Dorado, Puerto Rico 00646
Contact:
Site Coordinator
787-797-1049

GCM Medical Group PSC /ID# 249643
San Juan, Puerto Rico 00917-3104
Contact:
Site Coordinator
787-936-2100

Caribbean Medical Research Center /ID# 265301
San Juan, Puerto Rico 00918-3501

More Details

NCT ID
NCT05125302
Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

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