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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)

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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…

Phase 31.059 Teilnehmende gesucht129 Studienzentren2 Länder

Kategorien

Neurologie94%Gastroenterologie und Hepatologie6%

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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.

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

Zusammenfassung

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.

Erkrankungen

  • Migraine

Eignung

GeschlechtAlle
Alter6 Years – 17 Years
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungTRIPLE (3)
Teilnahme1.059 Teilnehmende gesucht

Sponsor und Mitwirkende

  • AbbVie Sponsor

Studienarme und Interventionen

  • 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.

Interventionen

  • Arzneimittel Placebo-Matching Ubrogepant

    Oral Tablet

  • Arzneimittel Ubrogepant

    Oral Tablet

Endpunkte

  1. Primärer Endpunkt

    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.

    Zeitrahmen 2 hours after initial dose

  2. Sekundärer Endpunkt

    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

    Zeitrahmen 2 hours after initial dose

  3. Sekundärer Endpunkt

    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.

    Zeitrahmen 2 hours after initial dose

  4. Sekundärer Endpunkt

    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.

    Zeitrahmen 2 to 24 hours after initial dose

  5. Sekundärer Endpunkt

    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

    Zeitrahmen 24 hours after initial dose

  6. Sekundärer Endpunkt

    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'.

    Zeitrahmen Baseline (Predose) to 2 hours after initial dose

  7. Sekundärer Endpunkt

    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'.

    Zeitrahmen Baseline (Predose) to 2 hours after initial dose

  8. Sekundärer Endpunkt

    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.

    Zeitrahmen 2 hours after initial dose

  9. Sekundärer Endpunkt

    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.

    Zeitrahmen 2 hours after initial dose

  10. Sekundärer Endpunkt

    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.

    Zeitrahmen 2 hours after initial dose

  11. Sekundärer Endpunkt

    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.

    Zeitrahmen 2 hours after initial dose

  12. Sekundärer Endpunkt

    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.

    Zeitrahmen Up to 6 months

  13. Sekundärer Endpunkt

    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.

    Zeitrahmen Up to 6 months

  14. Sekundärer Endpunkt

    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).

    Zeitrahmen Up to 6 months

  15. Sekundärer Endpunkt

    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.

    Zeitrahmen Up to 6 months

  16. Sekundärer Endpunkt

    Percentage of patients with suicidal ideation or suicidal behavior

    Zeitrahmen Up to 6 months

Daten

Startdatum13. Januar 2022 (tatsächlich)
Primärer Abschluss1. Mai 2027 (geschätzt)
Abschluss1. Mai 2027 (geschätzt)
Erstveröffentlichung18. November 2021 (tatsächlich)
Zuletzt aktualisiert14. September 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtSeptember 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

91 Studienzentren rekrutieren

Puerto Rico

EinrichtungStadtBundesland oder RegionStatus
Clinical Research Investigator Group /ID# 267454BayamónAbgeschlossen
Puerto Rico Health Institute /ID# 249162DoradoRekrutiert
GCM Medical Group /ID# 249643San JuanRekrutiert
Caribbean Medical Research Center Headlands /ID# 265301San JuanRekrutiert

United States

EinrichtungStadtBundesland oder RegionStatus
Accellacare - McFarland Clinic /ID# 229789AmesIowaRekrutiert
Dent Neurologic Institute - Amherst /ID# 231182AmherstNew YorkRekrutiert
Advanced Research Center /ID# 227962AnaheimCaliforniaRekrutiert
Hunterdon Neurology /ID# 245648AnnandaleNew JerseyAbgeschlossen
Treken Primary Care /ID# 240586AtlantaGeorgiaAbgeschlossen
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134AtlantaGeorgiaRekrutiert
Rare Disease Research /ID# 231046AtlantaGeorgiaRekrutiert
Children's Hospital Colorado - Aurora /ID# 231879AuroraColoradoRekrutiert
Paradigm Clinical Research - Aurora, CO /ID# 280612AuroraColoradoRekrutiert
Austin Regional Clinic - ARC Four Points /ID# 276301AustinTexasRekrutiert
UT Health Austin at Dell Children's Neurology Clinic /ID# 244266AustinTexasRekrutiert
BioBehavioral Research of Austin /ID# 230529AustinTexasAbgeschlossen
Velocity Clinical Research, Austin /ID# 230557AustinTexasRekrutiert
Pharmasite Research, Inc. /ID# 227908BaltimoreMarylandRekrutiert
Tekton Research - Beaumont /ID# 231207BeaumontTexasAbgeschlossen
Pantheon Clinical Research /ID# 250703BountifulUtahRekrutiert
Encore Medical Research of Boynton Beach LLC /ID# 246833Boynton BeachFloridaRekrutiert
Coastal Georgia Child Neurology /ID# 231409BrunswickGeorgiaRekrutiert
Minneapolis Clinic of Neurology - Burnsville /ID# 232551BurnsvilleMinnesotaRekrutiert
IMMUNOe Research Centers /ID# 230879CentennialColoradoAbgeschlossen
Coastal Pediatric Research /ID# 238616CharlestonSouth CarolinaAbgeschlossen
Onsite Clinical Solutions - Don Lochman Lane - Charlotte /ID# 282834CharlotteNorth CarolinaRekrutiert
CVS HealthHUB - Charlotte /ID# 239530CharlotteNorth CarolinaAbgeschlossen
Pediatric Associates of Charlottesville, PLC /ID# 230628CharlottesvilleVirginiaRekrutiert
Chicago Headache Center & Research Institute /ID# 248625ChicagoIllinoisRekrutiert
Headache Center of Hope /ID# 242645CincinnatiOhioRekrutiert
Cincinnati Childrens Hospital Medical Center /ID# 244689CincinnatiOhioRekrutiert
University Of Cincinnati Medical Center /ID# 231199CincinnatiOhioRekrutiert
Patient Priority Clinical Sites, LLC /ID# 238485CincinnatiOhioRekrutiert
MCB Clinical Research Centers - Colorado Springs - South Parkside Drive /ID# 231625Colorado SpringsColoradoAbgeschlossen
Centricity Research Columbus /ID# 231181ColumbusOhioRekrutiert
Relaro Medical Trials /ID# 239642DallasTexasRekrutiert
Cedar Health Research /ID# 228003DallasTexasRekrutiert
Epic Medical Research - DeSoto /ID# 274314DeSotoTexasRekrutiert
CenExcel iResearch LLC /ID# 227903DecaturGeorgiaAbgeschlossen
3A Research - East El Paso /ID# 239193El PasoTexasAbgeschlossen
Core Clinical Research /ID# 227904EverettWashingtonRekrutiert
Gulf Coast Clinical Research Center /ID# 230020Fort MyersFloridaRekrutiert
Office of Maria Ona /ID# 234232FranklinVirginiaAbgeschlossen
Neuro Pain Research Center /ID# 227966FresnoCaliforniaRekrutiert
Earle Research /ID# 231548FriendswoodTexasAbgeschlossen
Innovare Research Group, LLC /ID# 277617FriendswoodTexasRekrutiert
Sarkis Clinical Trials /ID# 227956GainesvilleFloridaAbgeschlossen
HealthStar Research Glenwood /ID# 275303GlenwoodArkansasRekrutiert
Tribe Clinical Research LLC /ID# 230422GreenvilleSouth CarolinaRekrutiert
Duplicate_Premier Neurology, P.C. /ID# 227999GreerSouth CarolinaAbgeschlossen

79 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 14. September 2026

    Studienzentrum hinzugefügt

    1 site added (129 total)

    128129

  2. 8. September 2026

    Studienzentrum hinzugefügt

    1 site added (128 total)

    127128

  3. 1. September 2026

    Studienzentrum hinzugefügt

    1 site added (127 total)

    126127

  4. 24. August 2026

    Studienzentrum hinzugefügt

    1 site added (126 total)

    125126

  5. 21. August 2026

    Studienzentrum entfernt

    4 sites removed (125 total)

    129125

Register: ClinicalTrials.gov · NCT########

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