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)

Migraine Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05125302
• Other study ID #: 3110-305-002
• Status: Recruiting
• Phase: Phase 3
• Start date: January 13, 2022
• Est. completion date: May 5, 2026

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 2 to 24 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1059
• Est. completion date: May 5, 2026
• Est. primary completion date: May 5, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Ubrogepant
Oral Tablet
• Placebo-Matching Ubrogepant
Oral Tablet

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico Health Institute /ID# 249162	Dorado
Puerto Rico	GCM Medical Group PSC /ID# 249643	San Juan
United States	Accellacare /ID# 229789	Ames	Iowa
United States	Dent Neurosciences Research Center, Inc. /ID# 231182	Amherst	New York
United States	Advanced Research Center /ID# 227962	Anaheim	California
United States	Hunterdon Neurology /ID# 245648	Annandale	New Jersey
United States	Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134	Atlanta	Georgia
United States	Rare Disease Research, LLC /ID# 231046	Atlanta	Georgia
United States	Treken Primary Care /ID# 240586	Atlanta	Georgia
United States	Children's Hospital Colorado - Aurora /ID# 231879	Aurora	Colorado
United States	BioBehavioral Research of Austin /ID# 230529	Austin	Texas
United States	UT Health Austin at Dell Children's Neurology Clinic /ID# 244266	Austin	Texas
United States	Pharmasite Research, Inc. /ID# 227908	Baltimore	Maryland
United States	Tekton Research - Beaumont /ID# 231207	Beaumont	Texas
United States	Pantheon Clinical Research /ID# 250703	Bountiful	Utah
United States	Encore Medical Research of Boynton Beach LLC /ID# 246833	Boynton Beach	Florida
United States	Coastal Georgia Child Neurology /ID# 231409	Brunswick	Georgia
United States	Minneapolis Clinic of Neurology - Burnsville /ID# 232551	Burnsville	Minnesota
United States	Velocity Clinical Research - Austin /ID# 230557	Cedar Park	Texas
United States	IMMUNOe Research Centers /ID# 230879	Centennial	Colorado
United States	Coastal Pediatric Research /ID# 238616	Charleston	South Carolina
United States	CVS HealthHUB - Charlotte /ID# 239530	Charlotte	North Carolina
United States	Chicago Headache Center & Research Institute /ID# 248625	Chicago	Illinois
United States	Cincinnati Childrens Hospital Medical Center /ID# 244689	Cincinnati	Ohio
United States	Headache Center of Hope /ID# 242645	Cincinnati	Ohio
United States	Patient Priority Clinical Sites, LLC /ID# 238485	Cincinnati	Ohio
United States	University of Cincinnati /ID# 231199	Cincinnati	Ohio
United States	MCB Clinical Research Centers /ID# 231625	Colorado Springs	Colorado
United States	Centricity Research Columbus /ID# 231181	Columbus	Ohio
United States	Cedar Health Research /ID# 228003	Dallas	Texas
United States	Relaro Medical Trials /ID# 239642	Dallas	Texas
United States	CenExcel iResearch LLC /ID# 227903	Decatur	Georgia
United States	3A Research - East El Paso /ID# 239193	El Paso	Texas
United States	Core Clinical Research /ID# 227904	Everett	Washington
United States	Gulf Coast Clinical Research Center /ID# 230020	Fort Myers	Florida
United States	Office of Maria Ona /ID# 234232	Franklin	Virginia
United States	Neuro Pain Medical Center /ID# 227966	Fresno	California
United States	Earle Research /ID# 231548	Friendswood	Texas
United States	Sarkis Clinical Trials /ID# 227956	Gainesville	Florida
United States	Tribe Clinical Research LLC /ID# 230422	Greenville	South Carolina
United States	Premier Neurology, P.C. /ID# 227999	Greer	South Carolina
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	OnSite Clinical Solutions, LLC - Hickory /ID# 227994	Hickory	North Carolina
United States	Encore Medical Research LLC /ID# 245682	Hollywood	Florida
United States	Advanced Research Institute of Miami /ID# 230292	Homestead	Florida
United States	DM Clinical Research /ID# 229826	Houston	Texas
United States	Houston Clinical Research Associates /ID# 244889	Houston	Texas
United States	Rehabilitation & Neurological Services /ID# 229969	Huntsville	Alabama
United States	Sante Clinical Research /ID# 246503	Kerrville	Texas
United States	Frontier Clinical Research - Kingwood /ID# 231914	Kingwood	West Virginia
United States	Sunwise Clinical Research /ID# 230971	Lafayette	California
United States	Auzmer Research /ID# 239251	Lakeland	Florida
United States	FMC Science /ID# 231915	Lampasas	Texas
United States	Preferred Research Partners /ID# 230725	Little Rock	Arkansas
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	Livingspring Family Medical Center /ID# 249869	Mansfield	Texas
United States	Velocity Clinical Research - Boise /ID# 231871	Meridian	Idaho
United States	Columbus Clinical Services, Llc /Id# 230880	Miami	Florida
United States	My Preferred Research LLC /ID# 227886	Miami	Florida
United States	Neurology & Pain Medicine /ID# 240168	Miami	Florida
United States	Goryeb Children's Hospital /ID# 229507	Morristown	New Jersey
United States	Bioscience Research /ID# 232159	Mount Kisco	New York
United States	Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312	Nashua	New Hampshire
United States	Access Clinical Trials, Inc. /ID# 228002	Nashville	Tennessee
United States	Modern Migraine MD /ID# 258081	New York	New York
United States	Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581	Norfolk	Virginia
United States	Excell Research, Inc /ID# 230899	Oceanside	California
United States	IPS Research Company /ID# 227961	Oklahoma City	Oklahoma
United States	Medical Research Group of Central Florida /ID# 231632	Orange City	Florida
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	Sharlin Health Neuroscience Research Center /ID# 229523	Ozark	Missouri
United States	Suncoast Clinical Research - Palm Harbor /ID# 229337	Palm Harbor	Florida
United States	Cognitive Clinical Trials (CCT) - Papillion /ID# 232552	Papillion	Nebraska
United States	MediSync Clinical Research Hattiesburg Clinic /ID# 233326	Petal	Mississippi
United States	Children's Hospital of Philadelphia - Main /ID# 232487	Philadelphia	Pennsylvania
United States	AIM Trials /ID# 230142	Plano	Texas
United States	North Suffolk Neurology /ID# 230956	Port Jefferson Station	New York
United States	Providence Brain and Spine Institute /ID# 231607	Portland	Oregon
United States	National Clinical Research /ID# 231320	Richmond	Virginia
United States	Proven Endpoints LLC /ID# 239513	Ridgeland	Mississippi
United States	CVS HealthHUB - Runnemede /ID# 234233	Runnemede	New Jersey
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	Road Runner Research /ID# 230527	San Antonio	Texas
United States	Lumos Clinical Research Center /ID# 231267	San Jose	California
United States	The Center for Clinical Trials - Saraland /ID# 231546	Saraland	Alabama
United States	Meridian Clinical Research LLC /ID# 228992	Savannah	Georgia
United States	Frontier Clinical Research, LLC - Scottdale /ID# 231913	Scottdale	Pennsylvania
United States	Frontier Clinical Research /ID# 231912	Smithfield	Pennsylvania
United States	Asclepes Research Centers - Spring Hill /ID# 229815	Spring Hill	Florida
United States	Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738	Stockbridge	Georgia
United States	SUNY Upstate Medical University /ID# 239898	Syracuse	New York
United States	University of South Florida- Neuroscience Institute /ID# 229324	Tampa	Florida
United States	Family Psychiatry of The Woodlands /ID# 230163	The Woodlands	Texas
United States	Pacific Clinical Research Management Group /ID# 231636	Upland	California
United States	Emerson Clinical Research Inst /ID# 231693	Washington	District of Columbia
United States	ClinPoint Trials /ID# 230295	Waxahachie	Texas
United States	CincyScience /ID# 230046	West Chester	Ohio
United States	Encore Medical Research - Weston /ID# 246809	Weston	Florida
United States	Alliance for Multispecialty Research (AMR) - Wichita West /ID# 234126	Wichita	Kansas
United States	Pediatrix Medical Group of Florida /ID# 229967	Winter Park	Florida
United States	Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years	Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.	2 hours after initial dose
Secondary	Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years	Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to	2 hours after initial dose
Secondary	Percentage of participants with Pain Relief at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years	Pain Relief is defined as a reduction in headache severity from moderate/severe at baseline to mild or no pain.	2 hours after initial dose
Secondary	Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose in pediatric participants aged 6 to 17 years	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.	2 to 24 hours after initial dose
Secondary	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
Secondary	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	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'.	Baseline (Predose) to 2 hours after initial dose
Secondary	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	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'.	Baseline (Predose) to 2 hours after initial dose
Secondary	Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 11 years	Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.	2 hours after initial dose
Secondary	Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years	Photophobia was defined as sensitivity to light, a migraine-associated symptom.	2 hours after initial dose
Secondary	Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years	Phonophobia was defined as sensitivity to sound, a migraine-associated symptom.	2 hours after initial dose
Secondary	Percentage of Participants With the Absence of Nausea at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years	Nausea was a migraine-associated symptom.	2 hours after initial dose
Secondary	Number of Participants with Adverse Events (AE)	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.	Up to 6 months
Secondary	Percentage of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed in pediatric participants aged 6 to 17 years	Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.	Up to 6 months
Secondary	Change From Baseline in Electrocardiograms (ECGs) in pediatric participants aged 6 to 17 years	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).	Up to 6 months
Secondary	Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements in pediatric participants aged 6 to 17 years	Percentage of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.	Up to 6 months
Secondary	Percentage of patients with suicidal ideation or suicidal behavior		Up to 6 months

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.