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)
- Registration Number
- NCT05125302
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1059
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Main Study: Children Ubrogepant Placebo Placebo-Matching Ubrogepant 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. Main Study: Adolescents Ubrogepant Placebo Placebo-Matching Ubrogepant 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. PK Cohort: Ubrogepant Dose A Ubrogepant Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study. Main Study: Children Ubrogepant Low Dose Ubrogepant 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. Main Study: Adolescents Ubrogepant Low Dose Ubrogepant 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. PK Cohort: Ubrogepant Dose B Ubrogepant Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study. Main Study: Children Ubrogepant High Dose Ubrogepant 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. Main Study: Adolescents Ubrogepant High Dose Ubrogepant 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.
- Primary Outcome Measures
Name Time Method Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years 2 hours after initial dose Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.
- Secondary Outcome Measures
Name Time Method Percentage of participants that used rescue medication (including a second dose of study intervention) within 24 hours after the initial dose in pediatric participants aged 6 to 17 years 24 hours after initial dose Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose in pediatric participants aged 6 to 17 years Baseline (Predose) to 2 hours after initial dose The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'.
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 11 years 2 hours after initial dose Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.
Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years 2 hours after initial dose Photophobia was defined as sensitivity to light, a migraine-associated symptom.
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years 2 hours after initial dose Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to
Percentage of patients with suicidal ideation or suicidal behavior Up to 6 months Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose in pediatric participants aged 12 to 17 years Baseline (Predose) to 2 hours after initial dose The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'.
Percentage of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed in pediatric participants aged 6 to 17 years Up to 6 months Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements in pediatric participants aged 6 to 17 years Up to 6 months Percentage of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Percentage of participants with Pain Relief at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years 2 hours after initial dose Pain Relief is defined as a reduction in headache severity from moderate/severe at baseline to mild or no pain.
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose in pediatric participants aged 6 to 17 years 2 to 24 hours after initial dose Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug.
Percentage of Participants With the Absence of Nausea at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years 2 hours after initial dose Nausea was a migraine-associated symptom.
Number of Participants with Adverse Events (AE) Up to 6 months 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 the Absence of Phonophobia at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years 2 hours after initial dose Phonophobia was defined as sensitivity to sound, a migraine-associated symptom.
Change From Baseline in Electrocardiograms (ECGs) in pediatric participants aged 6 to 17 years Up to 6 months 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).
Trial Locations
- Locations (111)
Paradigm Clinical Research - San Diego /ID# 269608
🇺🇸San Diego, California, United States
MCB Clinical Research Centers /ID# 231625
🇺🇸Colorado Springs, Colorado, United States
New England Institute for Clinical Research /ID# 230635
🇺🇸Stamford, Connecticut, United States
Rehabilitation & Neurological Services /ID# 229969
🇺🇸Huntsville, Alabama, United States
The Center for Clinical Trials - Saraland /ID# 231546
🇺🇸Saraland, Alabama, United States
Preferred Research Partners /ID# 230725
🇺🇸Little Rock, Arkansas, United States
Advanced Research Center /ID# 227962
🇺🇸Anaheim, California, United States
Neuro Pain Medical Center /ID# 227966
🇺🇸Fresno, California, United States
Alliance for Research Alliance for Wellness /ID# 230546
🇺🇸Long Beach, California, United States
Children's Hospital Los Angeles /ID# 230596
🇺🇸Los Angeles, California, United States
Excell Research, Inc /ID# 230899
🇺🇸Oceanside, California, United States
Lumos Clinical Research Center /ID# 231267
🇺🇸San Jose, California, United States
Pacific Clinical Research Management Group /ID# 231636
🇺🇸Upland, California, United States
Sunwise Clinical Research /ID# 230971
🇺🇸Walnut Creek, California, United States
Children's Hospital Colorado - Aurora /ID# 231879
🇺🇸Aurora, Colorado, United States
IMMUNOe Research Centers /ID# 230879
🇺🇸Centennial, Colorado, United States
Emerson Clinical Research Inst /ID# 231693
🇺🇸Washington, District of Columbia, United States
Encore Medical Research of Boynton Beach LLC /ID# 246833
🇺🇸Boynton Beach, Florida, United States
Gulf Coast Clinical Research Center /ID# 230020
🇺🇸Fort Myers, Florida, United States
Sarkis Clinical Trials /ID# 227956
🇺🇸Gainesville, Florida, United States
Northwest Florida Clinical Research Group, LLC /ID# 231069
🇺🇸Gulf Breeze, Florida, United States
A.G.A Clinical Trials /ID# 230554
🇺🇸Hialeah, Florida, United States
Encore Medical Research /ID# 245682
🇺🇸Hollywood, Florida, United States
Advanced Research Institute of Miami /ID# 230292
🇺🇸Homestead, Florida, United States
Neurology & Pain Medicine /ID# 240168
🇺🇸Miami, Florida, United States
Auzmer Research /ID# 239251
🇺🇸Lakeland, Florida, United States
Columbus Clinical Services, Llc /Id# 230880
🇺🇸Miami, Florida, United States
My Preferred Research LLC /ID# 227886
🇺🇸Miami, Florida, United States
Clinical Associates of Orlando, LLC /ID# 272619
🇺🇸Orlando, Florida, United States
Suncoast Clinical Research - Palm Harbor /ID# 229337
🇺🇸Palm Harbor, Florida, United States
Asclepes Research Centers - Spring Hill /ID# 229815
🇺🇸Spring Hill, Florida, United States
Medical Research Group of Central Florida /ID# 231632
🇺🇸Orange City, Florida, United States
University of South Florida- Neuroscience Institute /ID# 229324
🇺🇸Tampa, Florida, United States
Encore Medical Research - Weston /ID# 246809
🇺🇸Weston, Florida, United States
Pediatric Neurology and Epilepsy Specialists /ID# 229967
🇺🇸Winter Park, Florida, United States
Treken Primary Care /ID# 240586
🇺🇸Atlanta, Georgia, United States
Rare Disease Research, LLC /ID# 231046
🇺🇸Atlanta, Georgia, United States
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134
🇺🇸Atlanta, Georgia, United States
Coastal Georgia Child Neurology /ID# 231409
🇺🇸Brunswick, Georgia, United States
CenExcel iResearch LLC /ID# 227903
🇺🇸Decatur, Georgia, United States
Velocity Clinical Research - Savannah /ID# 228992
🇺🇸Savannah, Georgia, United States
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738
🇺🇸Stockbridge, Georgia, United States
Velocity Clinical Research - Boise /ID# 231871
🇺🇸Meridian, Idaho, United States
Chicago Headache Center & Research Institute /ID# 248625
🇺🇸Chicago, Illinois, United States
Accellacare - McFarland Clinic /ID# 229789
🇺🇸Ames, Iowa, United States
College Park Family Care Center Overland Park /ID# 231456
🇺🇸Overland Park, Kansas, United States
Psychiatric Associates /ID# 230872
🇺🇸Overland Park, Kansas, United States
Alliance for Multispecialty Research (AMR) - Wichita West /ID# 234126
🇺🇸Wichita, Kansas, United States
University of Kentucky Chandler Medical Center /ID# 230827
🇺🇸Lexington, Kentucky, United States
Pharmasite Research, Inc. /ID# 227908
🇺🇸Baltimore, Maryland, United States
Minneapolis Clinic of Neurology - Burnsville /ID# 232551
🇺🇸Burnsville, Minnesota, United States
MediSync Clinical Research Hattiesburg Clinic /ID# 233326
🇺🇸Petal, Mississippi, United States
Proven Endpoints LLC /ID# 239513
🇺🇸Ridgeland, Mississippi, United States
Sharlin Health Neuroscience Research Center /ID# 229523
🇺🇸Ozark, Missouri, United States
Cognitive Clinical Trials (CCT) - Papillion /ID# 232552
🇺🇸Papillion, Nebraska, United States
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312
🇺🇸Nashua, New Hampshire, United States
Hunterdon Neurology /ID# 245648
🇺🇸Annandale, New Jersey, United States
Goryeb Children's Hospital /ID# 229507
🇺🇸Morristown, New Jersey, United States
CVS HealthHUB - Runnemede /ID# 234233
🇺🇸Runnemede, New Jersey, United States
Dent Neurologic Institute - Amherst /ID# 231182
🇺🇸Amherst, New York, United States
Bioscience Research /ID# 232159
🇺🇸Mount Kisco, New York, United States
Modern Migraine MD /ID# 258081
🇺🇸New York, New York, United States
North Suffolk Neurology /ID# 230956
🇺🇸Port Jefferson Station, New York, United States
SUNY Upstate Medical University /ID# 239898
🇺🇸Syracuse, New York, United States
CVS HealthHUB - Charlotte /ID# 239530
🇺🇸Charlotte, North Carolina, United States
OnSite Clinical Solutions, LLC - Hickory /ID# 227994
🇺🇸Hickory, North Carolina, United States
University Of Cincinnati Medical Center /ID# 231199
🇺🇸Cincinnati, Ohio, United States
Patient Priority Clinical Sites, LLC /ID# 238485
🇺🇸Cincinnati, Ohio, United States
Cincinnati Childrens Hospital Medical Center /ID# 244689
🇺🇸Cincinnati, Ohio, United States
Headache Center of Hope /ID# 242645
🇺🇸Cincinnati, Ohio, United States
Centricity Research Columbus /ID# 231181
🇺🇸Columbus, Ohio, United States
CincyScience /ID# 230046
🇺🇸West Chester, Ohio, United States
IPS Research Company /ID# 227961
🇺🇸Oklahoma City, Oklahoma, United States
Providence Brain and Spine Institute /ID# 231607
🇺🇸Portland, Oregon, United States
Children's Hospital of Philadelphia - Main /ID# 232487
🇺🇸Philadelphia, Pennsylvania, United States
Frontier Clinical Research, LLC - Scottdale /ID# 231913
🇺🇸Scottdale, Pennsylvania, United States
Frontier Clinical Research /ID# 231912
🇺🇸Smithfield, Pennsylvania, United States
Coastal Pediatric Research /ID# 238616
🇺🇸Charleston, South Carolina, United States
Tribe Clinical Research LLC /ID# 230422
🇺🇸Greenville, South Carolina, United States
Duplicate_Premier Neurology, P.C. /ID# 227999
🇺🇸Greer, South Carolina, United States
Access Clinical Trials, Inc. /ID# 228002
🇺🇸Nashville, Tennessee, United States
UT Health Austin at Dell Children's Neurology Clinic /ID# 244266
🇺🇸Austin, Texas, United States
BioBehavioral Research of Austin /ID# 230529
🇺🇸Austin, Texas, United States
Velocity Clinical Research, Austin /ID# 230557
🇺🇸Austin, Texas, United States
Tekton Research - Beaumont /ID# 231207
🇺🇸Beaumont, Texas, United States
Relaro Medical Trials /ID# 239642
🇺🇸Dallas, Texas, United States
Cedar Health Research /ID# 228003
🇺🇸Dallas, Texas, United States
3A Research - East El Paso /ID# 239193
🇺🇸El Paso, Texas, United States
Earle Research /ID# 231548
🇺🇸Friendswood, Texas, United States
DM Clinical Research /ID# 229826
🇺🇸Houston, Texas, United States
Houston Clinical Research Associates /ID# 244889
🇺🇸Houston, Texas, United States
Sante Clinical Research /ID# 246503
🇺🇸Kerrville, Texas, United States
FMC Science /ID# 231915
🇺🇸Lampasas, Texas, United States
Livingspring Family Medical Center /ID# 249869
🇺🇸Mansfield, Texas, United States
AIM Trials /ID# 230142
🇺🇸Plano, Texas, United States
Road Runner Research /ID# 230527
🇺🇸San Antonio, Texas, United States
Family Psychiatry of The Woodlands /ID# 230163
🇺🇸The Woodlands, Texas, United States
ClinPoint Trials /ID# 230295
🇺🇸Waxahachie, Texas, United States
Pantheon Clinical Research /ID# 250703
🇺🇸Bountiful, Utah, United States
Highland Clinical Research /ID# 239362
🇺🇸Salt Lake City, Utah, United States
University of Utah Health Hospital /ID# 230908
🇺🇸Salt Lake City, Utah, United States
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976
🇺🇸Woodstock, Vermont, United States
Office of Maria Ona /ID# 234232
🇺🇸Franklin, Virginia, United States
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581
🇺🇸Norfolk, Virginia, United States
National Clinical Research /ID# 231320
🇺🇸Richmond, Virginia, United States
Core Clinical Research /ID# 227904
🇺🇸Everett, Washington, United States
Frontier Clinical Research - Kingwood /ID# 231914
🇺🇸Kingwood, West Virginia, United States
Clinical Research Investigator Group, LLC /ID# 267454
🇵🇷Bayamon, Puerto Rico
Puerto Rico Health Institute /ID# 249162
🇵🇷Dorado, Puerto Rico
GCM Medical Group PSC /ID# 249643
🇵🇷San Juan, Puerto Rico
Caribbean Medical Research Center /ID# 265301
🇵🇷San Juan, Puerto Rico