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 is this study for? Children and adolescents with a history of migraine
What treatments are being studied? Ubrogepant
Status: Recruiting
Location: See all (118) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Rehabilitation & Neurological Services /ID# 229969
RECRUITING
Huntsville
The Center for Clinical Trials - Saraland /ID# 231546
RECRUITING
Saraland
Arkansas
HealthStar Research of Hot Springs PLLC /ID# 273256
RECRUITING
Hot Springs
Preferred Research Partners /ID# 230725
RECRUITING
Little Rock
Arizona
Velocity Clinical Research - Phoenix /ID# 274478
RECRUITING
Phoenix
California
Advanced Research Center /ID# 227962
RECRUITING
Anaheim
Neuro Pain Medical Center /ID# 227966
RECRUITING
Fresno
Alliance for Research Alliance for Wellness /ID# 230546
RECRUITING
Long Beach
Children's Hospital Los Angeles /ID# 230596
COMPLETED
Los Angeles
Excell Research, Inc /ID# 230899
RECRUITING
Oceanside
Paradigm Clinical Research - San Diego /ID# 269608
RECRUITING
San Diego
Lumos Clinical Research Center /ID# 231267
RECRUITING
San Jose
Pacific Clinical Research Management Group /ID# 231636
RECRUITING
Upland
Sunwise Clinical Research /ID# 230971
RECRUITING
Walnut Creek
Amicis Research Center /ID# 272621
RECRUITING
Winnetka
Colorado
Childrens Hospital Colorado - Aurora /ID# 231879
RECRUITING
Aurora
IMMUNOe Research Centers /ID# 230879
COMPLETED
Centennial
MCB Clinical Research Centers /ID# 231625
COMPLETED
Colorado Springs
Connecticut
New England Institute for Clinical Research /ID# 230635
RECRUITING
Stamford
Washington, D.c.
Emerson Clinical Research Inst /ID# 231693
RECRUITING
Washington D.c.
Florida
Encore Medical Research of Boynton Beach LLC /ID# 246833
RECRUITING
Boynton Beach
Gulf Coast Clinical Research Center /ID# 230020
RECRUITING
Fort Myers
Sarkis Clinical Trials /ID# 227956
COMPLETED
Gainesville
Northwest Florida Clinical Research Group, LLC /ID# 231069
COMPLETED
Gulf Breeze
AGA Clinical Trials /ID# 230554
RECRUITING
Hialeah
Encore Medical Research /ID# 245682
RECRUITING
Hollywood
Advanced Research Institute of Miami /ID# 230292
RECRUITING
Homestead
Auzmer Research /ID# 239251
RECRUITING
Lakeland
Columbus Clinical Services, Llc /Id# 230880
RECRUITING
Miami
My Preferred Research LLC /ID# 227886
RECRUITING
Miami
Neurology & Pain Medicine /ID# 240168
COMPLETED
Miami
Medical Research Group of Central Florida /ID# 231632
RECRUITING
Orange City
Clinical Associates of Orlando, LLC /ID# 272619
RECRUITING
Orlando
Suncoast Clinical Research - Palm Harbor /ID# 229337
RECRUITING
Palm Harbor
Asclepes Research Centers - Spring Hill /ID# 229815
RECRUITING
Spring Hill
University of South Florida- Neuroscience Institute /ID# 229324
RECRUITING
Tampa
Encore Medical Research - Weston /ID# 246809
RECRUITING
Weston
Pediatric Neurology and Epilepsy Specialists /ID# 229967
RECRUITING
Winter Park
Georgia
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134
RECRUITING
Atlanta
Rare Disease Research, LLC /ID# 231046
RECRUITING
Atlanta
Treken Primary Care /ID# 240586
COMPLETED
Atlanta
Coastal Georgia Child Neurology /ID# 231409
RECRUITING
Brunswick
CenExcel iResearch LLC /ID# 227903
RECRUITING
Decatur
Velocity Clinical Research - Savannah /ID# 228992
RECRUITING
Savannah
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738
COMPLETED
Stockbridge
Iowa
Accellacare - McFarland Clinic /ID# 229789
RECRUITING
Ames
Idaho
Velocity Clinical Research - Boise /ID# 231871
RECRUITING
Meridian
Illinois
Chicago Headache Center & Research Institute /ID# 248625
RECRUITING
Chicago
Kansas
Clinical Associates Midwest, LLC /ID# 274315
RECRUITING
Overland Park
College Park Family Care Center Overland Park /ID# 231456
COMPLETED
Overland Park
Psychiatric Associates /ID# 230872
COMPLETED
Overland Park
Alliance for Multispecialty Research - Wichita East /ID# 234126
RECRUITING
Wichita
Kentucky
University of Kentucky Chandler Medical Center /ID# 230827
RECRUITING
Lexington
Maryland
Pharmasite Research, Inc. /ID# 227908
RECRUITING
Baltimore
Minnesota
Minneapolis Clinic of Neurology - Burnsville /ID# 232551
RECRUITING
Burnsville
Missouri
Sharlin Health and Neurology /ID# 229523
RECRUITING
Ozark
Mississippi
MediSync Clinical Research Hattiesburg Clinic /ID# 233326
COMPLETED
Petal
Proven Endpoints LLC /ID# 239513
RECRUITING
Ridgeland
North Carolina
CVS HealthHUB - Charlotte /ID# 239530
COMPLETED
Charlotte
OnSite Clinical Solutions, LLC - Hickory /ID# 227994
COMPLETED
Hickory
Nebraska
Cognitive Clinical Trials (CCT) - Papillion /ID# 232552
RECRUITING
Papillion
New Hampshire
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312
RECRUITING
Nashua
New Jersey
Hunterdon Neurology /ID# 245648
COMPLETED
Annandale
Goryeb Childrens Hospital /ID# 229507
RECRUITING
Morristown
CVS HealthHUB - Runnemede /ID# 234233
COMPLETED
Runnemede
New York
Dent Neurologic Institute - Amherst /ID# 231182
RECRUITING
Amherst
Bioscience Research /ID# 232159
COMPLETED
Mount Kisco
Modern Migraine MD /ID# 258081
COMPLETED
New York
North Suffolk Neurology /ID# 230956
COMPLETED
Port Jefferson Station
SUNY Upstate Medical University /ID# 239898
RECRUITING
Syracuse
Ohio
Cincinnati Childrens Hospital Medical Center /ID# 244689
RECRUITING
Cincinnati
Headache Center of Hope /ID# 242645
RECRUITING
Cincinnati
Patient Priority Clinical Sites, LLC /ID# 238485
RECRUITING
Cincinnati
University Of Cincinnati Medical Center /ID# 231199
RECRUITING
Cincinnati
Centricity Research Columbus /ID# 231181
RECRUITING
Columbus
CincyScience /ID# 230046
RECRUITING
West Chester
Oklahoma
IPS Research Company /ID# 227961
COMPLETED
Oklahoma City
Oregon
Providence Brain and Spine Institute /ID# 231607
RECRUITING
Portland
Pennsylvania
Children's Hospital of Philadelphia - Main /ID# 232487
RECRUITING
Philadelphia
Frontier Clinical Research, LLC - Scottdale /ID# 231913
RECRUITING
Scottdale
Frontier Clinical Research - Smithfield /ID# 231912
RECRUITING
Smithfield
South Carolina
Coastal Pediatric Research /ID# 238616
COMPLETED
Charleston
Tribe Clinical Research LLC /ID# 230422
RECRUITING
Greenville
Duplicate_Premier Neurology, P.C. /ID# 227999
COMPLETED
Greer
Tennessee
Access Clinical Trials, Inc. /ID# 228002
RECRUITING
Nashville
Texas
BioBehavioral Research of Austin /ID# 230529
COMPLETED
Austin
UT Health Austin at Dell Children's Neurology Clinic /ID# 244266
RECRUITING
Austin
Velocity Clinical Research, Austin /ID# 230557
RECRUITING
Austin
Tekton Research - Beaumont /ID# 231207
RECRUITING
Beaumont
Cedar Health Research /ID# 228003
RECRUITING
Dallas
Relaro Medical Trials /ID# 239642
RECRUITING
Dallas
Epic Medical Research - DeSoto /ID# 274314
RECRUITING
Desoto
3A Research - East El Paso /ID# 239193
RECRUITING
El Paso
Earle Research /ID# 231548
COMPLETED
Friendswood
DM Clinical Research /ID# 229826
RECRUITING
Houston
Houston Clinical Research Associates /ID# 244889
RECRUITING
Houston
Pioneer Research Solutions - Houston - Stancliff Road /ID# 274316
RECRUITING
Houston
Sante Clinical Research /ID# 246503
RECRUITING
Kerrville
FMC Science /ID# 231915
RECRUITING
Lampasas
Livingspring Family Medical Center /ID# 249869
RECRUITING
Mansfield
AIM Trials /ID# 230142
RECRUITING
Plano
Road Runner Research /ID# 230527
RECRUITING
San Antonio
Family Psychiatry of The Woodlands /ID# 230163
RECRUITING
The Woodlands
ClinPoint Trials /ID# 230295
RECRUITING
Waxahachie
Utah
Pantheon Clinical Research /ID# 250703
RECRUITING
Bountiful
Highland Clinical Research /ID# 239362
RECRUITING
Salt Lake City
University of Utah Health Hospital /ID# 230908
COMPLETED
Salt Lake City
Virginia
Office of Maria Ona /ID# 234232
COMPLETED
Franklin
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581
RECRUITING
Norfolk
National Clinical Research /ID# 231320
COMPLETED
Richmond
Vermont
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976
COMPLETED
Woodstock
Washington
Core Clinical Research /ID# 227904
RECRUITING
Everett
Wisconsin
Mind+ Neurology /ID# 275529
RECRUITING
Mequon
West Virginia
Frontier Clinical Research - Kingwood /ID# 231914
RECRUITING
Kingwood
Other Locations
Puerto Rico
Clinical Research Investigator Group, LLC /ID# 267454
COMPLETED
Bayamón
Puerto Rico Health Institute /ID# 249162
RECRUITING
Dorado
Caribbean Medical Research Center /ID# 265301
RECRUITING
San Juan
GCM Medical Group PSC /ID# 249643
RECRUITING
San Juan
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2022-01-13
Estimated Completion Date: 2026-05
Participants
Target number of participants: 1059
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov