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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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En resumen

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…

Fase 31059 participantes buscados129 centros2 países

Categorías

Neurología94%Gastroenterología y hepatología6%

Registrado en 1 registro

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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.

Resumen

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.

Afecciones

  • Migraine

Elegibilidad

SexoTodos
Edades6 Years – 17 Years
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoTRIPLE (3)
Inscripción1059 participantes buscados

Patrocinador y colaboradores

  • AbbVie Patrocinador

Grupos e intervenciones

  • 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.

Intervenciones

  • Fármaco Placebo-Matching Ubrogepant

    Oral Tablet

  • Fármaco Ubrogepant

    Oral Tablet

Variables de resultado

  1. Variable de resultado principal

    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.

    Plazo 2 hours after initial dose

  2. Variable de resultado secundaria

    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

    Plazo 2 hours after initial dose

  3. Variable de resultado secundaria

    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.

    Plazo 2 hours after initial dose

  4. Variable de resultado secundaria

    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.

    Plazo 2 to 24 hours after initial dose

  5. Variable de resultado secundaria

    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

    Plazo 24 hours after initial dose

  6. Variable de resultado secundaria

    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'.

    Plazo Baseline (Predose) to 2 hours after initial dose

  7. Variable de resultado secundaria

    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'.

    Plazo Baseline (Predose) to 2 hours after initial dose

  8. Variable de resultado secundaria

    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.

    Plazo 2 hours after initial dose

  9. Variable de resultado secundaria

    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.

    Plazo 2 hours after initial dose

  10. Variable de resultado secundaria

    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.

    Plazo 2 hours after initial dose

  11. Variable de resultado secundaria

    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.

    Plazo 2 hours after initial dose

  12. Variable de resultado secundaria

    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.

    Plazo Up to 6 months

  13. Variable de resultado secundaria

    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.

    Plazo Up to 6 months

  14. Variable de resultado secundaria

    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).

    Plazo Up to 6 months

  15. Variable de resultado secundaria

    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.

    Plazo Up to 6 months

  16. Variable de resultado secundaria

    Percentage of patients with suicidal ideation or suicidal behavior

    Plazo Up to 6 months

Fechas

Fecha de inicio13 de enero de 2022 (real)
Finalización principal1 de mayo de 2027 (estimada)
Finalización1 de mayo de 2027 (estimada)
Primera publicación18 de noviembre de 2021 (real)
Última actualización14 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

91 centros están en reclutamiento

Puerto Rico

CentroCiudadEstado o regiónEstado
Clinical Research Investigator Group /ID# 267454BayamónCompletado
Puerto Rico Health Institute /ID# 249162DoradoEn reclutamiento
GCM Medical Group /ID# 249643San JuanEn reclutamiento
Caribbean Medical Research Center Headlands /ID# 265301San JuanEn reclutamiento

United States

CentroCiudadEstado o regiónEstado
Accellacare - McFarland Clinic /ID# 229789AmesIowaEn reclutamiento
Dent Neurologic Institute - Amherst /ID# 231182AmherstNew YorkEn reclutamiento
Advanced Research Center /ID# 227962AnaheimCaliforniaEn reclutamiento
Hunterdon Neurology /ID# 245648AnnandaleNew JerseyCompletado
Treken Primary Care /ID# 240586AtlantaGeorgiaCompletado
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134AtlantaGeorgiaEn reclutamiento
Rare Disease Research /ID# 231046AtlantaGeorgiaEn reclutamiento
Children's Hospital Colorado - Aurora /ID# 231879AuroraColoradoEn reclutamiento
Paradigm Clinical Research - Aurora, CO /ID# 280612AuroraColoradoEn reclutamiento
Austin Regional Clinic - ARC Four Points /ID# 276301AustinTexasEn reclutamiento
UT Health Austin at Dell Children's Neurology Clinic /ID# 244266AustinTexasEn reclutamiento
BioBehavioral Research of Austin /ID# 230529AustinTexasCompletado
Velocity Clinical Research, Austin /ID# 230557AustinTexasEn reclutamiento
Pharmasite Research, Inc. /ID# 227908BaltimoreMarylandEn reclutamiento
Tekton Research - Beaumont /ID# 231207BeaumontTexasCompletado
Pantheon Clinical Research /ID# 250703BountifulUtahEn reclutamiento
Encore Medical Research of Boynton Beach LLC /ID# 246833Boynton BeachFloridaEn reclutamiento
Coastal Georgia Child Neurology /ID# 231409BrunswickGeorgiaEn reclutamiento
Minneapolis Clinic of Neurology - Burnsville /ID# 232551BurnsvilleMinnesotaEn reclutamiento
IMMUNOe Research Centers /ID# 230879CentennialColoradoCompletado
Coastal Pediatric Research /ID# 238616CharlestonSouth CarolinaCompletado
Onsite Clinical Solutions - Don Lochman Lane - Charlotte /ID# 282834CharlotteNorth CarolinaEn reclutamiento
CVS HealthHUB - Charlotte /ID# 239530CharlotteNorth CarolinaCompletado
Pediatric Associates of Charlottesville, PLC /ID# 230628CharlottesvilleVirginiaEn reclutamiento
Chicago Headache Center & Research Institute /ID# 248625ChicagoIllinoisEn reclutamiento
Headache Center of Hope /ID# 242645CincinnatiOhioEn reclutamiento
Cincinnati Childrens Hospital Medical Center /ID# 244689CincinnatiOhioEn reclutamiento
University Of Cincinnati Medical Center /ID# 231199CincinnatiOhioEn reclutamiento
Patient Priority Clinical Sites, LLC /ID# 238485CincinnatiOhioEn reclutamiento
MCB Clinical Research Centers - Colorado Springs - South Parkside Drive /ID# 231625Colorado SpringsColoradoCompletado
Centricity Research Columbus /ID# 231181ColumbusOhioEn reclutamiento
Relaro Medical Trials /ID# 239642DallasTexasEn reclutamiento
Cedar Health Research /ID# 228003DallasTexasEn reclutamiento
Epic Medical Research - DeSoto /ID# 274314DeSotoTexasEn reclutamiento
CenExcel iResearch LLC /ID# 227903DecaturGeorgiaCompletado
3A Research - East El Paso /ID# 239193El PasoTexasCompletado
Core Clinical Research /ID# 227904EverettWashingtonEn reclutamiento
Gulf Coast Clinical Research Center /ID# 230020Fort MyersFloridaEn reclutamiento
Office of Maria Ona /ID# 234232FranklinVirginiaCompletado
Neuro Pain Research Center /ID# 227966FresnoCaliforniaEn reclutamiento
Earle Research /ID# 231548FriendswoodTexasCompletado
Innovare Research Group, LLC /ID# 277617FriendswoodTexasEn reclutamiento
Sarkis Clinical Trials /ID# 227956GainesvilleFloridaCompletado
HealthStar Research Glenwood /ID# 275303GlenwoodArkansasEn reclutamiento
Tribe Clinical Research LLC /ID# 230422GreenvilleSouth CarolinaEn reclutamiento
Duplicate_Premier Neurology, P.C. /ID# 227999GreerSouth CarolinaCompletado

En el registro figuran 79 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 14 de septiembre de 2026

    Centro añadido

    1 site added (129 total)

    128129

  2. 8 de septiembre de 2026

    Centro añadido

    1 site added (128 total)

    127128

  3. 1 de septiembre de 2026

    Centro añadido

    1 site added (127 total)

    126127

  4. 24 de agosto de 2026

    Centro añadido

    1 site added (126 total)

    125126

  5. 21 de agosto de 2026

    Centro eliminado

    4 sites removed (125 total)

    129125

Registro: ClinicalTrials.gov · NCT########

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