NCT05125302ClinicalTrials.gov

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)

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)

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

שלב 3דרושים 1,059 משתתפים129 אתרים2 מדינות

קטגוריות

נוירולוגיה94%גסטרואנטרולוגיה והפטולוגיה6%

רשום במרשם אחד

ClinicalTrials.govNCT05125302פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני 5 ימים

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2021-11-18; recorded start 2022-01-13
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 378 other studies in this databaseCounted from the lead sponsor named in the record (AbbVie)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding16/20
Triple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 129 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 1,059 participants (target), run at 129 sites, across 2 countries.

How this score is built

Enrolment30/40
1,059 participants (target)
Site count23/25
129 sites
Country count7/15
2 countries
Planned duration10/10
Planned over about 64 months
Sponsor scale9/10
AbbVie has led 364 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

תקציר

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.

מצבים רפואיים

Migraine

זכאות

זכאות
מין	הכול
גילאים	6 Years – 17 Years
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	שלב 3
הקצאה	אקראי
מודל ההתערבות	PARALLEL
מטרה ראשית	TREATMENT
הסתרה	TRIPLE (3)
גיוס	דרושים 1,059 משתתפים

נותן חסות ושותפים

AbbVie נותן חסות

זרועות והתערבויות

PK Cohort: Ubrogepant Dose AEXPERIMENTAL
Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
PK Cohort: Ubrogepant Dose BEXPERIMENTAL
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 DoseEXPERIMENTAL
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: Children Ubrogepant High DoseEXPERIMENTAL
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: Children Ubrogepant PlaceboPLACEBO_COMPARATOR
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 Low DoseEXPERIMENTAL
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.
Main Study: Adolescents Ubrogepant High DoseEXPERIMENTAL
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.
Main Study: Adolescents Ubrogepant PlaceboPLACEBO_COMPARATOR
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.

התערבויות

תרופה Placebo-Matching Ubrogepant
Oral Tablet
תרופה Ubrogepant
Oral Tablet

מדדי תוצאה

מדד תוצאה ראשוני
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.
מסגרת זמן 2 hours after initial dose
מדד תוצאה משני
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
מסגרת זמן 2 hours after initial dose
מדד תוצאה משני
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.
מסגרת זמן 2 hours after initial dose
מדד תוצאה משני
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.
מסגרת זמן 2 to 24 hours after initial dose
מדד תוצאה משני
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
מסגרת זמן 24 hours after initial dose
מדד תוצאה משני
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'.
מסגרת זמן Baseline (Predose) to 2 hours after initial dose
מדד תוצאה משני
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'.
מסגרת זמן Baseline (Predose) to 2 hours after initial dose
מדד תוצאה משני
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.
מסגרת זמן 2 hours after initial dose
מדד תוצאה משני
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.
מסגרת זמן 2 hours after initial dose
מדד תוצאה משני
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.
מסגרת זמן 2 hours after initial dose
מדד תוצאה משני
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.
מסגרת זמן 2 hours after initial dose
מדד תוצאה משני
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.
מסגרת זמן Up to 6 months
מדד תוצאה משני
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.
מסגרת זמן Up to 6 months
מדד תוצאה משני
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).
מסגרת זמן Up to 6 months
מדד תוצאה משני
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.
מסגרת זמן Up to 6 months
מדד תוצאה משני
Percentage of patients with suicidal ideation or suicidal behavior
מסגרת זמן Up to 6 months

תאריכים

תאריכים
תאריך התחלה	13 בינואר 2022 (בפועל)
סיום ראשוני	1 במאי 2027 (משוער)
סיום	1 במאי 2027 (משוער)
פורסם לראשונה	18 בנובמבר 2021 (בפועל)
עודכן לאחרונה	14 בספטמבר 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	ספטמבר 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

91 אתרים מגייסים

Puerto Rico

Puerto Rico
מתקן	עיר	מצב
Clinical Research Investigator Group /ID# 267454	Bayamón	הושלם
Puerto Rico Health Institute /ID# 249162	Dorado	מגייס
GCM Medical Group /ID# 249643	San Juan	מגייס
Caribbean Medical Research Center Headlands /ID# 265301	San Juan	מגייס

United States

United States
מתקן	עיר	מדינה או אזור	מצב
Accellacare - McFarland Clinic /ID# 229789	Ames	Iowa	מגייס
Dent Neurologic Institute - Amherst /ID# 231182	Amherst	New York	מגייס
Advanced Research Center /ID# 227962	Anaheim	California	מגייס
Hunterdon Neurology /ID# 245648	Annandale	New Jersey	הושלם
Treken Primary Care /ID# 240586	Atlanta	Georgia	הושלם
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134	Atlanta	Georgia	מגייס
Rare Disease Research /ID# 231046	Atlanta	Georgia	מגייס
Children's Hospital Colorado - Aurora /ID# 231879	Aurora	Colorado	מגייס
Paradigm Clinical Research - Aurora, CO /ID# 280612	Aurora	Colorado	מגייס
Austin Regional Clinic - ARC Four Points /ID# 276301	Austin	Texas	מגייס
UT Health Austin at Dell Children's Neurology Clinic /ID# 244266	Austin	Texas	מגייס
BioBehavioral Research of Austin /ID# 230529	Austin	Texas	הושלם
Velocity Clinical Research, Austin /ID# 230557	Austin	Texas	מגייס
Pharmasite Research, Inc. /ID# 227908	Baltimore	Maryland	מגייס
Tekton Research - Beaumont /ID# 231207	Beaumont	Texas	הושלם
Pantheon Clinical Research /ID# 250703	Bountiful	Utah	מגייס
Encore Medical Research of Boynton Beach LLC /ID# 246833	Boynton Beach	Florida	מגייס
Coastal Georgia Child Neurology /ID# 231409	Brunswick	Georgia	מגייס
Minneapolis Clinic of Neurology - Burnsville /ID# 232551	Burnsville	Minnesota	מגייס
IMMUNOe Research Centers /ID# 230879	Centennial	Colorado	הושלם
Coastal Pediatric Research /ID# 238616	Charleston	South Carolina	הושלם
Onsite Clinical Solutions - Don Lochman Lane - Charlotte /ID# 282834	Charlotte	North Carolina	מגייס
CVS HealthHUB - Charlotte /ID# 239530	Charlotte	North Carolina	הושלם
Pediatric Associates of Charlottesville, PLC /ID# 230628	Charlottesville	Virginia	מגייס
Chicago Headache Center & Research Institute /ID# 248625	Chicago	Illinois	מגייס
Headache Center of Hope /ID# 242645	Cincinnati	Ohio	מגייס
Cincinnati Childrens Hospital Medical Center /ID# 244689	Cincinnati	Ohio	מגייס
University Of Cincinnati Medical Center /ID# 231199	Cincinnati	Ohio	מגייס
Patient Priority Clinical Sites, LLC /ID# 238485	Cincinnati	Ohio	מגייס
MCB Clinical Research Centers - Colorado Springs - South Parkside Drive /ID# 231625	Colorado Springs	Colorado	הושלם
Centricity Research Columbus /ID# 231181	Columbus	Ohio	מגייס
Relaro Medical Trials /ID# 239642	Dallas	Texas	מגייס
Cedar Health Research /ID# 228003	Dallas	Texas	מגייס
Epic Medical Research - DeSoto /ID# 274314	DeSoto	Texas	מגייס
CenExcel iResearch LLC /ID# 227903	Decatur	Georgia	הושלם
3A Research - East El Paso /ID# 239193	El Paso	Texas	הושלם
Core Clinical Research /ID# 227904	Everett	Washington	מגייס
Gulf Coast Clinical Research Center /ID# 230020	Fort Myers	Florida	מגייס
Office of Maria Ona /ID# 234232	Franklin	Virginia	הושלם
Neuro Pain Research Center /ID# 227966	Fresno	California	מגייס
Earle Research /ID# 231548	Friendswood	Texas	הושלם
Innovare Research Group, LLC /ID# 277617	Friendswood	Texas	מגייס
Sarkis Clinical Trials /ID# 227956	Gainesville	Florida	הושלם
HealthStar Research Glenwood /ID# 275303	Glenwood	Arkansas	מגייס
Tribe Clinical Research LLC /ID# 230422	Greenville	South Carolina	מגייס
Duplicate_Premier Neurology, P.C. /ID# 227999	Greer	South Carolina	הושלם

79 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

14 בספטמבר 2026
אתר נוסף
1 site added (129 total)
128129
8 בספטמבר 2026
אתר נוסף
1 site added (128 total)
127128
1 בספטמבר 2026
אתר נוסף
1 site added (127 total)
126127
24 באוגוסט 2026
אתר נוסף
1 site added (126 total)
125126
21 באוגוסט 2026
אתר הוסר
4 sites removed (125 total)
129125

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05125302