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)
- 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
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ubrogepant Dose A (12 to 17 Years Old) Ubrogepant Participants 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) Ubrogepant Participants 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
Name Time Method 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 Parameters Up 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 values Up 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 Behavior Up 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 Cycle Up 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 score Up 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) questionnaire up 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
Name Time Method
Trial Locations
- Locations (106)
Pediatrix Medical Group of Florida /ID# 233336
🇺🇸Winter Park, Florida, United States
Centricity Research Columbus /ID# 238832
🇺🇸Columbus, Ohio, United States
Houston Clinical Research Associates /ID# 246522
🇺🇸Houston, Texas, United States
Excell Research, Inc /ID# 233495
🇺🇸Oceanside, California, United States
Advanced Research Center /ID# 238967
🇺🇸Anaheim, California, United States
Meridian Clinical Research LLC /ID# 231873
🇺🇸Savannah, Georgia, United States
Children's Hospital Los Angeles /ID# 239446
🇺🇸Los Angeles, California, United States
CVS HealthHUB - Runnemede /ID# 240057
🇺🇸Runnemede, New Jersey, United States
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 238852
🇺🇸Atlanta, Georgia, United States
Advanced Research Institute of Miami /ID# 240712
🇺🇸Homestead, Florida, United States
Dent Neurosciences Research Center, Inc. /ID# 238415
🇺🇸Amherst, New York, United States
Sunwise Clinical Research /ID# 238458
🇺🇸Lafayette, California, United States
College Park Family Care Center Overland Park /ID# 240707
🇺🇸Overland Park, Kansas, United States
Suncoast Clinical Research Pasco County /ID# 233535
🇺🇸New Port Richey, Florida, United States
Alliance for Research Alliance for Wellness /ID# 233497
🇺🇸Long Beach, California, United States
Cognitive Clinical Trials (CCT) - Papillion /ID# 239835
🇺🇸Papillion, Nebraska, United States
Bioscience Research /ID# 239442
🇺🇸Mount Kisco, New York, United States
CenExcel iResearch LLC /ID# 239832
🇺🇸Decatur, Georgia, United States
SUNY Upstate Medical University /ID# 241140
🇺🇸Syracuse, New York, United States
Alliance for Multispecialty Research (AMR) - Wichita West /ID# 239829
🇺🇸Wichita, Kansas, United States
The Center for Clinical Trials - Saraland /ID# 239448
🇺🇸Saraland, Alabama, United States
Lumos Clinical Research Center /ID# 239018
🇺🇸San Jose, California, United States
IMMUNOe Research Centers /ID# 240846
🇺🇸Centennial, Colorado, United States
Neuro Pain Medical Center /ID# 239135
🇺🇸Fresno, California, United States
Psychiatric Associates /ID# 240710
🇺🇸Overland Park, Kansas, United States
Children's Hospital of Philadelphia - Main /ID# 241138
🇺🇸Philadelphia, Pennsylvania, United States
Global Research Associates /ID# 243504
🇺🇸Atlanta, Georgia, United States
Chicago Headache Center & Research Institute /ID# 254071
🇺🇸Chicago, Illinois, United States
Pacific Clinical Research Management Group /ID# 238503
🇺🇸Upland, California, United States
Coastal Georgia Child Neurology /ID# 240845
🇺🇸Brunswick, Georgia, United States
Emerson Clinical Research Inst /ID# 238455
🇺🇸Washington, District of Columbia, United States
Velocity Clinical Research - Boise /ID# 238978
🇺🇸Meridian, Idaho, United States
Minneapolis Clinic of Neurology - Burnsville /ID# 238828
🇺🇸Burnsville, Minnesota, United States
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 239441
🇺🇸Nashua, New Hampshire, United States
Tekton Research - Beaumont /ID# 238407
🇺🇸Beaumont, Texas, United States
Goryeb Children's Hospital /ID# 239425
🇺🇸Morristown, New Jersey, United States
CincyScience /ID# 233334
🇺🇸West Chester, Ohio, United States
Velocity Clinical Research - Austin /ID# 233406
🇺🇸Cedar Park, Texas, United States
GCM Medical Group PSC /ID# 250561
🇵🇷San Juan, Puerto Rico
ClinPoint Trials /ID# 238406
🇺🇸Waxahachie, Texas, United States
Core Clinical Research /ID# 233421
🇺🇸Everett, Washington, United States
Frontier Clinical Research, LLC - Scottdale /ID# 239017
🇺🇸Scottdale, Pennsylvania, United States
Caribbean Medical Research Center /ID# 265292
🇵🇷San Juan, Puerto Rico
Pantheon Clinical Research /ID# 251475
🇺🇸Bountiful, Utah, United States
Cedar Health Research /ID# 233403
🇺🇸Dallas, Texas, United States
Tribe Clinical Research LLC /ID# 239143
🇺🇸Greenville, South Carolina, United States
Earle Research /ID# 238940
🇺🇸Friendswood, Texas, United States
Frontier Clinical Research - Kingwood /ID# 238459
🇺🇸Kingwood, West Virginia, United States
Relaro Medical Trials /ID# 241141
🇺🇸Dallas, Texas, United States
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 239142
🇺🇸Norfolk, Virginia, United States
Puerto Rico Health Institute /ID# 250560
🇵🇷Dorado, Puerto Rico
3A Research - East El Paso /ID# 241665
🇺🇸El Paso, Texas, United States
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 240055
🇺🇸Woodstock, Vermont, United States
IPS Research Company /ID# 231876
🇺🇸Oklahoma City, Oklahoma, United States
University of Cincinnati /ID# 238461
🇺🇸Cincinnati, Ohio, United States
Access Clinical Trials, Inc. /ID# 238414
🇺🇸Nashville, Tennessee, United States
Road Runner Research /ID# 238360
🇺🇸San Antonio, Texas, United States
Highland Clinical Research /ID# 240053
🇺🇸Salt Lake City, Utah, United States
University of Utah Health Hospital /ID# 239021
🇺🇸Salt Lake City, Utah, United States
Providence Pediatric Neurology - St. Vincent /ID# 240050
🇺🇸Portland, Oregon, United States
Sharlin Health Neuroscience Research Center /ID# 238969
🇺🇸Ozark, Missouri, United States
Sante Clinical Research /ID# 248333
🇺🇸Kerrville, Texas, United States
DM Clinical Research /ID# 238361
🇺🇸Houston, Texas, United States
FMC Science /ID# 240475
🇺🇸Lampasas, Texas, United States
Livingspring Family Medical Center /ID# 252194
🇺🇸Mansfield, Texas, United States
Encore Medical Research LLC /ID# 247463
🇺🇸Hollywood, Florida, United States
Neurology & Pain Medicine /ID# 241860
🇺🇸Miami, Florida, United States
Children's Hospital Colorado - Aurora /ID# 239838
🇺🇸Aurora, Colorado, United States
University of South Florida- Neuroscience Institute /ID# 233420
🇺🇸Tampa, Florida, United States
Auzmer Research /ID# 241514
🇺🇸Lakeland, Florida, United States
Accellacare /ID# 238490
🇺🇸Ames, Iowa, United States
Proven Endpoints LLC /ID# 240974
🇺🇸Ridgeland, Mississippi, United States
Patient Priority Clinical Sites, LLC /ID# 240051
🇺🇸Cincinnati, Ohio, United States
Cincinnati Childrens Hospital Medical Center /ID# 247491
🇺🇸Cincinnati, Ohio, United States
Headache Center of Hope /ID# 244819
🇺🇸Cincinnati, Ohio, United States
AIM Trials /ID# 233425
🇺🇸Plano, Texas, United States
MediSync Clinical Research Hattiesburg Clinic /ID# 239837
🇺🇸Petal, Mississippi, United States
CVS HealthHUB - Charlotte /ID# 240842
🇺🇸Charlotte, North Carolina, United States
Rehabilitation & Neurological Services /ID# 240054
🇺🇸Huntsville, Alabama, United States
Preferred Research Partners /ID# 238979
🇺🇸Little Rock, Arkansas, United States
MCB Clinical Research Centers /ID# 240999
🇺🇸Colorado Springs, Colorado, United States
Northwest Florida Clinical Research Group, LLC /ID# 244396
🇺🇸Gulf Breeze, Florida, United States
Gulf Coast Clinical Research Center /ID# 233335
🇺🇸Fort Myers, Florida, United States
A.G.A Clinical Trials /ID# 238409
🇺🇸Hialeah, Florida, United States
Encore Medical Research of Boynton Beach LLC /ID# 248720
🇺🇸Boynton Beach, Florida, United States
Encore Medical Research - Weston /ID# 248335
🇺🇸Weston, Florida, United States
Columbus Clinical Services, Llc /Id# 238968
🇺🇸Miami, Florida, United States
My Preferred Research LLC /ID# 239020
🇺🇸Miami, Florida, United States
Medical Research Group of Central Florida /ID# 240711
🇺🇸Orange City, Florida, United States
Asclepes Research Centers - Spring Hill /ID# 231872
🇺🇸Spring Hill, Florida, United States
Rare Disease Research, LLC /ID# 238833
🇺🇸Atlanta, Georgia, United States
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 238454
🇺🇸Stockbridge, Georgia, United States
Pharmasite Research, Inc. /ID# 233414
🇺🇸Baltimore, Maryland, United States
Hunterdon Neurology /ID# 248222
🇺🇸Annandale, New Jersey, United States
North Suffolk Neurology /ID# 238457
🇺🇸Port Jefferson Station, New York, United States
Modern Migraine MD /ID# 263140
🇺🇸New York, New York, United States
OnSite Clinical Solutions, LLC - Hickory /ID# 238946
🇺🇸Hickory, North Carolina, United States
Frontier Clinical Research /ID# 238502
🇺🇸Smithfield, Pennsylvania, United States
Premier Neurology, P.C. /ID# 233419
🇺🇸Greer, South Carolina, United States
Family Psychiatry of The Woodlands /ID# 238980
🇺🇸The Woodlands, Texas, United States
Office of Maria Ona /ID# 239833
🇺🇸Franklin, Virginia, United States
Coastal Pediatric Research /ID# 240708
🇺🇸Charleston, South Carolina, United States
National Clinical Research /ID# 238419
🇺🇸Richmond, Virginia, United States
Sarkis Clinical Trials /ID# 233493
🇺🇸Gainesville, Florida, United States
UT Health Austin at Dell Children's Neurology Clinic /ID# 246570
🇺🇸Austin, Texas, United States
BioBehavioral Research of Austin /ID# 233427
🇺🇸Austin, Texas, United States