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Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)

Phase 3
Conditions
Migraine
Interventions
Registration Number
NCT05127954
Lead Sponsor
AbbVie
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 long term safety and tolerability of ubrogepant in the acute treatment of migraine in pediatric participants.

Ubrogepant is a drug approved for the acute treatment of migraine in adults. Pediatric participants (aged 6-17 years) with a history of migraine will be enrolled. Participants who completed the lead-in Study 3110-305-002, as well as those who were placebo responders and screen failed, will be eligible to enroll into this study. Around 1200 participants will be enrolled in the study at approximately 120 sites in the United States.

Participants may receive ubrogepant oral tables to treat up to 8 migraine attacks of any intensity per month. There will be an option to take a second dose of study intervention (identical to initial dose), or rescue medication, starting 2 hours after the initial dose. The study duration will be up to 54 weeks.

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 safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

Detailed Description

Not available

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
1200
Inclusion Criteria
  • Completers of the lead-in Study 3110-305-002 (in the main study or PK cohort) or those who screen failed due to being placebo responders.
  • Demonstrated an acceptable degree of compliance with study procedures in the lead-in study and who, in the investigator's clinical judgment, did not experience an AE that may indicate an unacceptable safety risk for this study.
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Exclusion Criteria
  • 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.
  • An ECG with clinically significant abnormalities at Visit 1 as determined by the investigator.
  • Clinically significant abnormalities in physical examination at Visit 1, as determined by the investigator.
  • Significant risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator; participants should be excluded if they report suicidal ideation with intent, with or without a plan (ie, Type 4 or 5 on the C-SSRS), or report suicidal behavior at Visit 1
  • Any medical or other reason (eg, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study) that, in the investigator's opinion, might indicate that the participant is unsuitable for the study.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ubrogepant Dose A (12 to 17 Years Old)UbrogepantParticipants will receive oral tablets of ubrogepant Dose A for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, at least 2 hours after initial dose for headache of any intensity.
Ubrogepant Dose B (6 to 11 Years Old)UbrogepantParticipants will receive the highest dose of oral tablets of ubrogepant tested in Study 3110-305-002 for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, at least 2 hours after initial dose for headache of any intensity.
Primary Outcome Measures
NameTimeMethod
Percentage of Participants with Adverse Events (AEs)up to 54 weeks

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Percentage of Participants with Potentially Clinically Significant Vital Sign ParametersUp to 54 Weeks

Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)Up to 54 Weeks

12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).

Percentage of Participants with Potentially Clinically Significant lab valuesUp to 54 Weeks

Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.

Percentage of with Participants with Suicidal Ideation or Suicidal BehaviorUp to 54 Weeks

The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt).

Percentage of Participants with Change in Menstrual CycleUp to 54 Weeks

Female participants who have entered menarche are to be asked for the date of the first and last day of their most recent menstrual period.

Change from baseline in Tanner staging scoreUp to 54 Weeks

Tanner's staging is used to assess growth and pubertal development.

Change From baseline in Behavior Rating Inventory of Executive Function (BRIEF 2) questionnaireup to 54 weeks

The BRIEF 2 is an 86-item questionnaire assessing executive function. It consists of 2 indexes, Behavioral Regulation and Metacognition, which are then used to calculate an overall composite score. Higher scores indicate more executive difficulties

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (106)

Pediatrix Medical Group of Florida /ID# 233336

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Winter Park, Florida, United States

Centricity Research Columbus /ID# 238832

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Columbus, Ohio, United States

Houston Clinical Research Associates /ID# 246522

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Houston, Texas, United States

Excell Research, Inc /ID# 233495

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Oceanside, California, United States

Advanced Research Center /ID# 238967

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Anaheim, California, United States

Meridian Clinical Research LLC /ID# 231873

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Savannah, Georgia, United States

Children's Hospital Los Angeles /ID# 239446

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Los Angeles, California, United States

CVS HealthHUB - Runnemede /ID# 240057

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Runnemede, New Jersey, United States

Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 238852

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Atlanta, Georgia, United States

Advanced Research Institute of Miami /ID# 240712

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Homestead, Florida, United States

Dent Neurosciences Research Center, Inc. /ID# 238415

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Amherst, New York, United States

Sunwise Clinical Research /ID# 238458

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Lafayette, California, United States

College Park Family Care Center Overland Park /ID# 240707

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Overland Park, Kansas, United States

Suncoast Clinical Research Pasco County /ID# 233535

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New Port Richey, Florida, United States

Alliance for Research Alliance for Wellness /ID# 233497

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Long Beach, California, United States

Cognitive Clinical Trials (CCT) - Papillion /ID# 239835

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Papillion, Nebraska, United States

Bioscience Research /ID# 239442

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Mount Kisco, New York, United States

CenExcel iResearch LLC /ID# 239832

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Decatur, Georgia, United States

SUNY Upstate Medical University /ID# 241140

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Syracuse, New York, United States

Alliance for Multispecialty Research (AMR) - Wichita West /ID# 239829

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Wichita, Kansas, United States

The Center for Clinical Trials - Saraland /ID# 239448

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Saraland, Alabama, United States

Lumos Clinical Research Center /ID# 239018

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San Jose, California, United States

IMMUNOe Research Centers /ID# 240846

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Centennial, Colorado, United States

Neuro Pain Medical Center /ID# 239135

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Fresno, California, United States

Psychiatric Associates /ID# 240710

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Overland Park, Kansas, United States

Children's Hospital of Philadelphia - Main /ID# 241138

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Philadelphia, Pennsylvania, United States

Global Research Associates /ID# 243504

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Atlanta, Georgia, United States

Chicago Headache Center & Research Institute /ID# 254071

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Chicago, Illinois, United States

Pacific Clinical Research Management Group /ID# 238503

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Upland, California, United States

Coastal Georgia Child Neurology /ID# 240845

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Brunswick, Georgia, United States

Emerson Clinical Research Inst /ID# 238455

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Washington, District of Columbia, United States

Velocity Clinical Research - Boise /ID# 238978

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Meridian, Idaho, United States

Minneapolis Clinic of Neurology - Burnsville /ID# 238828

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Burnsville, Minnesota, United States

Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 239441

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Nashua, New Hampshire, United States

Tekton Research - Beaumont /ID# 238407

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Beaumont, Texas, United States

Goryeb Children's Hospital /ID# 239425

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Morristown, New Jersey, United States

CincyScience /ID# 233334

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West Chester, Ohio, United States

Velocity Clinical Research - Austin /ID# 233406

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Cedar Park, Texas, United States

GCM Medical Group PSC /ID# 250561

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San Juan, Puerto Rico

ClinPoint Trials /ID# 238406

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Waxahachie, Texas, United States

Core Clinical Research /ID# 233421

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Everett, Washington, United States

Frontier Clinical Research, LLC - Scottdale /ID# 239017

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Scottdale, Pennsylvania, United States

Caribbean Medical Research Center /ID# 265292

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San Juan, Puerto Rico

Pantheon Clinical Research /ID# 251475

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Bountiful, Utah, United States

Cedar Health Research /ID# 233403

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Dallas, Texas, United States

Tribe Clinical Research LLC /ID# 239143

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Greenville, South Carolina, United States

Earle Research /ID# 238940

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Friendswood, Texas, United States

Frontier Clinical Research - Kingwood /ID# 238459

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Kingwood, West Virginia, United States

Relaro Medical Trials /ID# 241141

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Dallas, Texas, United States

Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 239142

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Norfolk, Virginia, United States

Puerto Rico Health Institute /ID# 250560

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Dorado, Puerto Rico

3A Research - East El Paso /ID# 241665

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El Paso, Texas, United States

Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 240055

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Woodstock, Vermont, United States

IPS Research Company /ID# 231876

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Oklahoma City, Oklahoma, United States

University of Cincinnati /ID# 238461

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Cincinnati, Ohio, United States

Access Clinical Trials, Inc. /ID# 238414

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Nashville, Tennessee, United States

Road Runner Research /ID# 238360

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San Antonio, Texas, United States

Highland Clinical Research /ID# 240053

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Salt Lake City, Utah, United States

University of Utah Health Hospital /ID# 239021

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Salt Lake City, Utah, United States

Providence Pediatric Neurology - St. Vincent /ID# 240050

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Portland, Oregon, United States

Sharlin Health Neuroscience Research Center /ID# 238969

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Ozark, Missouri, United States

Sante Clinical Research /ID# 248333

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Kerrville, Texas, United States

DM Clinical Research /ID# 238361

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Houston, Texas, United States

FMC Science /ID# 240475

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Lampasas, Texas, United States

Livingspring Family Medical Center /ID# 252194

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Mansfield, Texas, United States

Encore Medical Research LLC /ID# 247463

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Hollywood, Florida, United States

Neurology & Pain Medicine /ID# 241860

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Miami, Florida, United States

Children's Hospital Colorado - Aurora /ID# 239838

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Aurora, Colorado, United States

University of South Florida- Neuroscience Institute /ID# 233420

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Tampa, Florida, United States

Auzmer Research /ID# 241514

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Lakeland, Florida, United States

Accellacare /ID# 238490

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Ames, Iowa, United States

Proven Endpoints LLC /ID# 240974

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Ridgeland, Mississippi, United States

Patient Priority Clinical Sites, LLC /ID# 240051

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Cincinnati, Ohio, United States

Cincinnati Childrens Hospital Medical Center /ID# 247491

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Cincinnati, Ohio, United States

Headache Center of Hope /ID# 244819

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Cincinnati, Ohio, United States

AIM Trials /ID# 233425

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Plano, Texas, United States

MediSync Clinical Research Hattiesburg Clinic /ID# 239837

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Petal, Mississippi, United States

CVS HealthHUB - Charlotte /ID# 240842

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Charlotte, North Carolina, United States

Rehabilitation & Neurological Services /ID# 240054

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Huntsville, Alabama, United States

Preferred Research Partners /ID# 238979

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Little Rock, Arkansas, United States

MCB Clinical Research Centers /ID# 240999

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Colorado Springs, Colorado, United States

Northwest Florida Clinical Research Group, LLC /ID# 244396

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Gulf Breeze, Florida, United States

Gulf Coast Clinical Research Center /ID# 233335

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Fort Myers, Florida, United States

A.G.A Clinical Trials /ID# 238409

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Hialeah, Florida, United States

Encore Medical Research of Boynton Beach LLC /ID# 248720

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Boynton Beach, Florida, United States

Encore Medical Research - Weston /ID# 248335

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Weston, Florida, United States

Columbus Clinical Services, Llc /Id# 238968

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Miami, Florida, United States

My Preferred Research LLC /ID# 239020

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Miami, Florida, United States

Medical Research Group of Central Florida /ID# 240711

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Orange City, Florida, United States

Asclepes Research Centers - Spring Hill /ID# 231872

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Spring Hill, Florida, United States

Rare Disease Research, LLC /ID# 238833

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Atlanta, Georgia, United States

Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 238454

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Stockbridge, Georgia, United States

Pharmasite Research, Inc. /ID# 233414

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Baltimore, Maryland, United States

Hunterdon Neurology /ID# 248222

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Annandale, New Jersey, United States

North Suffolk Neurology /ID# 238457

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Port Jefferson Station, New York, United States

Modern Migraine MD /ID# 263140

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New York, New York, United States

OnSite Clinical Solutions, LLC - Hickory /ID# 238946

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Hickory, North Carolina, United States

Frontier Clinical Research /ID# 238502

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Smithfield, Pennsylvania, United States

Premier Neurology, P.C. /ID# 233419

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Greer, South Carolina, United States

Family Psychiatry of The Woodlands /ID# 238980

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The Woodlands, Texas, United States

Office of Maria Ona /ID# 239833

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Franklin, Virginia, United States

Coastal Pediatric Research /ID# 240708

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Charleston, South Carolina, United States

National Clinical Research /ID# 238419

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Richmond, Virginia, United States

Sarkis Clinical Trials /ID# 233493

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Gainesville, Florida, United States

UT Health Austin at Dell Children's Neurology Clinic /ID# 246570

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Austin, Texas, United States

BioBehavioral Research of Austin /ID# 233427

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Austin, Texas, United States

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