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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)

Primary Purpose

Migraine

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ubrogepant
Placebo-Matching Ubrogepant
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Ubrogepant, Ubrelvy, PERISCOPE

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation & Neurological Services /ID# 229969Recruiting
  • The Center for Clinical Trials - Saraland /ID# 231546Recruiting
  • Preferred Research Partners /ID# 230725Recruiting
  • Advanced Research Center /ID# 227962Recruiting
  • Neuro Pain Medical Center /ID# 227966Recruiting
  • Sunwise Clinical Research /ID# 230971Recruiting
  • Alliance for Research - Long Beach /ID# 230546Recruiting
  • Children's Hospital Los Angeles /ID# 230596Recruiting
  • Excell Research, Inc /ID# 230899Recruiting
  • Lumos Clinical Research Center /ID# 231267Recruiting
  • Pacific Clinical Research Management Group /ID# 231636Recruiting
  • Children's Hospital Colorado /ID# 231879Recruiting
  • IMMUNOe Research Centers /ID# 230879Recruiting
  • MCB Clinical Research Centers /ID# 231625Recruiting
  • Emerson Clinical Research Inst /ID# 231693Recruiting
  • Encore Medical Research of Boynton Beach LLC /ID# 246833Recruiting
  • Gulfcoast Clinical Research Center /ID# 230020Recruiting
  • Sarkis Clinical Trials /ID# 227956Recruiting
  • Northwest Florida Clinical Research Group, LLC /ID# 231069Recruiting
  • A.G.A Clinical Trials /ID# 230554Recruiting
  • Encore Medical Research LLC /ID# 245682Recruiting
  • Advanced Research Institute of Miami /ID# 230292Recruiting
  • Auzmer Research /ID# 239251Recruiting
  • Columbus Clinical Services, Llc /Id# 230880Recruiting
  • My Preferred Research LLC /ID# 227886Recruiting
  • Neurology & Pain Medicine /ID# 240168Recruiting
  • Medical Research Group of Central Florida /ID# 231632Recruiting
  • Suncoast Clinical Research - Palm Harbor /ID# 229337Recruiting
  • Asclepes Research Centers - Spring Hill /ID# 229815Recruiting
  • University of South Florida /ID# 229324Recruiting
  • Encore Medical Research of Weston LLC /ID# 246809Recruiting
  • Pediatrix Medical Group of Florida /ID# 229967Recruiting
  • Rare Disease Research, LLC /ID# 231046Recruiting
  • Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134Recruiting
  • Coastal Georgia Child Neurology /ID# 231409Recruiting
  • CenExcel iResearch LLC /ID# 227903Recruiting
  • Meridian Clinical Research LLC /ID# 228992Recruiting
  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738Recruiting
  • Velocity Clinical Research - Boise /ID# 231871Recruiting
  • Chicago Headache Center & Research Institute /ID# 248625Recruiting
  • Accellacare /ID# 229789Recruiting
  • College Park Family Care Center Overland Park /ID# 231456Recruiting
  • Psychiatric Associates /ID# 230872Recruiting
  • Alliance for Multispecialty Research (AMR) - Wichita West /ID# 234126Recruiting
  • Pharmasite Research, Inc. /ID# 227908Recruiting
  • Minneapolis Clinic of Neurology - Burnsville /ID# 232551Recruiting
  • MediSync Clinical Research Hattiesburg Clinic /ID# 233326Recruiting
  • Proven Endpoints LLC /ID# 239513Recruiting
  • Sharlin Health Neuroscience Research Center /ID# 229523Recruiting
  • Cognitive Clinical Trials (CCT) - Papillion /ID# 232552Recruiting
  • Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312Recruiting
  • Hunterdon Neurology /ID# 245648Recruiting
  • Goryeb Children's Hospital /ID# 229507Recruiting
  • CVS HealthHUB - Runnemede /ID# 234233Recruiting
  • Dent Neurosciences Research Center, Inc. /ID# 231182Recruiting
  • Bioscience Research /ID# 232159Recruiting
  • North Suffolk Neurology /ID# 230956Recruiting
  • SUNY Upstate Medical University /ID# 239898Recruiting
  • CVS HealthHUB - Charlotte /ID# 239530Recruiting
  • OnSite Clinical Solutions, LLC - Hickory /ID# 227994Recruiting
  • Patient Priority Clinical Sites, LLC /ID# 238485Recruiting
  • Headache Center of Hope /ID# 242645Recruiting
  • University of Cincinnati /ID# 231199Recruiting
  • Centricity Research Columbus /ID# 231181Recruiting
  • CincyScience /ID# 230046Recruiting
  • IPS Research Company /ID# 227961
  • Children's Hospital of Philadelphia - Main /ID# 232487Recruiting
  • Frontier Clinical Research, LLC - Scottdale /ID# 231913Recruiting
  • Frontier Clinical Research /ID# 231912Recruiting
  • Coastal Pediatric Research /ID# 238616Recruiting
  • Tribe Clinical Research LLC /ID# 230422Recruiting
  • Premier Neurology, P.C. /ID# 227999
  • Access Clinical Trials, Inc. /ID# 228002Recruiting
  • BioBehavioral Research of Austin /ID# 230529Recruiting
  • Tekton Research - Beaumont /ID# 231207Recruiting
  • Velocity Clinical Research - Austin /ID# 230557Recruiting
  • Relaro Medical Trials /ID# 239642Recruiting
  • Cedar Health Research /ID# 228003Recruiting
  • 3A Research - East El Paso /ID# 239193Recruiting
  • Earle Research /ID# 231548Recruiting
  • DM Clinical Research /ID# 229826Recruiting
  • Houston Clinical Research Associates /ID# 244889Recruiting
  • Sante Clinical Research /ID# 246503Recruiting
  • FMC Science /ID# 231915Recruiting
  • Livingspring Family Medical Center /ID# 249869Recruiting
  • AIM Trials /ID# 230142Recruiting
  • Road Runner Research /ID# 230527Recruiting
  • Family Psychiatry of The Woodlands /ID# 230163Recruiting
  • ClinPoint Trials /ID# 230295Recruiting
  • Pantheon Clinical Research /ID# 250703Recruiting
  • Highland Clinical Research /ID# 239362Recruiting
  • Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976
  • Office of Maria Ona /ID# 234232Recruiting
  • Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581Recruiting
  • National Clinical Research /ID# 231320Recruiting
  • Core Clinical Research /ID# 227904Recruiting
  • Frontier Clinical Research - Kingwood /ID# 231914Recruiting
  • Puerto Rico Health Institute /ID# 249162Recruiting
  • GCM Medical Group PSC /ID# 249643Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

PK Cohort: Ubrogepant Dose A

PK Cohort: Ubrogepant Dose B

Main Study: Children Ubrogepant Low Dose

Main Study: Children Ubrogepant High Dose

Main Study: Children Ubrogepant Placebo

Main Study: Adolescents Ubrogepant Low Dose

Main Study: Adolescents Ubrogepant High Dose

Main Study: Adolescents Ubrogepant Placebo

Arm Description

Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.

Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.

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, 2 to 24 hours after initial dose for headache of moderate/severe intensity.

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, 2 to 24 hours after initial dose for headache of moderate/severe intensity.

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, 2 to 24 hours after initial dose for headache of moderate/severe intensity.

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, 2 to 24 hours after initial dose for headache of moderate/severe intensity.

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, 2 to 24 hours after initial dose for headache of moderate/severe intensity.

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, 2 to 24 hours after initial dose for headache of moderate/severe intensity.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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
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'.
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'.
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.
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.
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.
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.
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.
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.
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).
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.
Percentage of patients with suicidal ideation or suicidal behavior

Full Information

First Posted
November 8, 2021
Last Updated
October 17, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05125302
Brief Title
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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
May 5, 2026 (Anticipated)
Study Completion Date
May 5, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment. For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Ubrogepant, Ubrelvy, PERISCOPE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1059 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PK Cohort: Ubrogepant Dose A
Arm Type
Experimental
Arm Description
Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
Arm Title
PK Cohort: Ubrogepant Dose B
Arm Type
Experimental
Arm Description
Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
Arm Title
Main Study: Children Ubrogepant Low Dose
Arm Type
Experimental
Arm Description
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, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Arm Title
Main Study: Children Ubrogepant High Dose
Arm Type
Experimental
Arm Description
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, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Arm Title
Main Study: Children Ubrogepant Placebo
Arm Type
Placebo Comparator
Arm Description
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, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Arm Title
Main Study: Adolescents Ubrogepant Low Dose
Arm Type
Experimental
Arm Description
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, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Arm Title
Main Study: Adolescents Ubrogepant High Dose
Arm Type
Experimental
Arm Description
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, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Arm Title
Main Study: Adolescents Ubrogepant Placebo
Arm Type
Placebo Comparator
Arm Description
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, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Intervention Type
Drug
Intervention Name(s)
Ubrogepant
Other Intervention Name(s)
Ubrelvy
Intervention Description
Oral Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo-Matching Ubrogepant
Intervention Description
Oral Tablet
Primary Outcome Measure Information:
Title
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Description
Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.
Time Frame
2 hours after initial dose
Secondary Outcome Measure Information:
Title
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years
Description
Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to
Time Frame
2 hours after initial dose
Title
Percentage of participants with Pain Relief at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years
Description
Pain Relief is defined as a reduction in headache severity from moderate/severe at baseline to mild or no pain.
Time Frame
2 hours after initial dose
Title
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose in pediatric participants aged 6 to 17 years
Description
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.
Time Frame
2 to 24 hours after initial dose
Title
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
Time Frame
24 hours after initial dose
Title
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
Description
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'.
Time Frame
Baseline (Predose) to 2 hours after initial dose
Title
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
Description
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'.
Time Frame
Baseline (Predose) to 2 hours after initial dose
Title
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 11 years
Description
Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.
Time Frame
2 hours after initial dose
Title
Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Description
Photophobia was defined as sensitivity to light, a migraine-associated symptom.
Time Frame
2 hours after initial dose
Title
Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Description
Phonophobia was defined as sensitivity to sound, a migraine-associated symptom.
Time Frame
2 hours after initial dose
Title
Percentage of Participants With the Absence of Nausea at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Description
Nausea was a migraine-associated symptom.
Time Frame
2 hours after initial dose
Title
Number of Participants with Adverse Events (AE)
Description
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.
Time Frame
Up to 6 months
Title
Percentage of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed in pediatric participants aged 6 to 17 years
Description
Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Time Frame
Up to 6 months
Title
Change From Baseline in Electrocardiograms (ECGs) in pediatric participants aged 6 to 17 years
Description
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).
Time Frame
Up to 6 months
Title
Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements in pediatric participants aged 6 to 17 years
Description
Percentage of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Time Frame
Up to 6 months
Title
Percentage of patients with suicidal ideation or suicidal behavior
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Rehabilitation & Neurological Services /ID# 229969
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805-4046
Country
United States
Individual Site Status
Recruiting
Facility Name
The Center for Clinical Trials - Saraland /ID# 231546
City
Saraland
State/Province
Alabama
ZIP/Postal Code
36571
Country
United States
Individual Site Status
Recruiting
Facility Name
Preferred Research Partners /ID# 230725
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Research Center /ID# 227962
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Recruiting
Facility Name
Neuro Pain Medical Center /ID# 227966
City
Fresno
State/Province
California
ZIP/Postal Code
93710-5473
Country
United States
Individual Site Status
Recruiting
Facility Name
Sunwise Clinical Research /ID# 230971
City
Lafayette
State/Province
California
ZIP/Postal Code
94549-4579
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Research - Long Beach /ID# 230546
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Los Angeles /ID# 230596
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
Excell Research, Inc /ID# 230899
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Individual Site Status
Recruiting
Facility Name
Lumos Clinical Research Center /ID# 231267
City
San Jose
State/Province
California
ZIP/Postal Code
95124-4108
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Clinical Research Management Group /ID# 231636
City
Upland
State/Province
California
ZIP/Postal Code
91786-3676
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Colorado /ID# 231879
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
IMMUNOe Research Centers /ID# 230879
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Name
MCB Clinical Research Centers /ID# 231625
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Individual Site Status
Recruiting
Facility Name
Emerson Clinical Research Inst /ID# 231693
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Individual Site Status
Recruiting
Facility Name
Encore Medical Research of Boynton Beach LLC /ID# 246833
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33436-7245
Country
United States
Individual Site Status
Recruiting
Facility Name
Gulfcoast Clinical Research Center /ID# 230020
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarkis Clinical Trials /ID# 227956
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Florida Clinical Research Group, LLC /ID# 231069
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561-4495
Country
United States
Individual Site Status
Recruiting
Facility Name
A.G.A Clinical Trials /ID# 230554
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Encore Medical Research LLC /ID# 245682
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021-6476
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Research Institute of Miami /ID# 230292
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030-4613
Country
United States
Individual Site Status
Recruiting
Facility Name
Auzmer Research /ID# 239251
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33813-2768
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbus Clinical Services, Llc /Id# 230880
City
Miami
State/Province
Florida
ZIP/Postal Code
33125-5114
Country
United States
Individual Site Status
Recruiting
Facility Name
My Preferred Research LLC /ID# 227886
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurology & Pain Medicine /ID# 240168
City
Miami
State/Province
Florida
ZIP/Postal Code
33186-7661
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Research Group of Central Florida /ID# 231632
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Name
Suncoast Clinical Research - Palm Harbor /ID# 229337
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Individual Site Status
Recruiting
Facility Name
Asclepes Research Centers - Spring Hill /ID# 229815
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609-5692
Country
United States
Individual Site Status
Recruiting
Facility Name
University of South Florida /ID# 229324
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Encore Medical Research of Weston LLC /ID# 246809
City
Weston
State/Province
Florida
ZIP/Postal Code
33331-3642
Country
United States
Individual Site Status
Recruiting
Facility Name
Pediatrix Medical Group of Florida /ID# 229967
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789-7111
Country
United States
Individual Site Status
Recruiting
Facility Name
Rare Disease Research, LLC /ID# 231046
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318-2512
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Georgia Child Neurology /ID# 231409
City
Brunswick
State/Province
Georgia
ZIP/Postal Code
31520-1601
Country
United States
Individual Site Status
Recruiting
Facility Name
CenExcel iResearch LLC /ID# 227903
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research LLC /ID# 228992
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Recruiting
Facility Name
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - Boise /ID# 231871
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Name
Chicago Headache Center & Research Institute /ID# 248625
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
(773-935-1000)
Facility Name
Accellacare /ID# 229789
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Individual Site Status
Recruiting
Facility Name
College Park Family Care Center Overland Park /ID# 231456
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210-2761
Country
United States
Individual Site Status
Recruiting
Facility Name
Psychiatric Associates /ID# 230872
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66221
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research (AMR) - Wichita West /ID# 234126
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205-1138
Country
United States
Individual Site Status
Recruiting
Facility Name
Pharmasite Research, Inc. /ID# 227908
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Individual Site Status
Recruiting
Facility Name
Minneapolis Clinic of Neurology - Burnsville /ID# 232551
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337-6732
Country
United States
Individual Site Status
Recruiting
Facility Name
MediSync Clinical Research Hattiesburg Clinic /ID# 233326
City
Petal
State/Province
Mississippi
ZIP/Postal Code
39465-2932
Country
United States
Individual Site Status
Recruiting
Facility Name
Proven Endpoints LLC /ID# 239513
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Individual Site Status
Recruiting
Facility Name
Sharlin Health Neuroscience Research Center /ID# 229523
City
Ozark
State/Province
Missouri
ZIP/Postal Code
65721-5315
Country
United States
Individual Site Status
Recruiting
Facility Name
Cognitive Clinical Trials (CCT) - Papillion /ID# 232552
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046-4131
Country
United States
Individual Site Status
Recruiting
Facility Name
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060-3483
Country
United States
Individual Site Status
Recruiting
Facility Name
Hunterdon Neurology /ID# 245648
City
Annandale
State/Province
New Jersey
ZIP/Postal Code
08801-3127
Country
United States
Individual Site Status
Recruiting
Facility Name
Goryeb Children's Hospital /ID# 229507
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Name
CVS HealthHUB - Runnemede /ID# 234233
City
Runnemede
State/Province
New Jersey
ZIP/Postal Code
08078-1034
Country
United States
Individual Site Status
Recruiting
Facility Name
Dent Neurosciences Research Center, Inc. /ID# 231182
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Name
Bioscience Research /ID# 232159
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549-3028
Country
United States
Individual Site Status
Recruiting
Facility Name
North Suffolk Neurology /ID# 230956
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776-3387
Country
United States
Individual Site Status
Recruiting
Facility Name
SUNY Upstate Medical University /ID# 239898
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Name
CVS HealthHUB - Charlotte /ID# 239530
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210-8905
Country
United States
Individual Site Status
Recruiting
Facility Name
OnSite Clinical Solutions, LLC - Hickory /ID# 227994
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Individual Site Status
Recruiting
Facility Name
Patient Priority Clinical Sites, LLC /ID# 238485
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215-2123
Country
United States
Individual Site Status
Recruiting
Facility Name
Headache Center of Hope /ID# 242645
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236-1875
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Cincinnati /ID# 231199
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Individual Site Status
Recruiting
Facility Name
Centricity Research Columbus /ID# 231181
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Name
CincyScience /ID# 230046
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Individual Site Status
Recruiting
Facility Name
IPS Research Company /ID# 227961
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Individual Site Status
Completed
Facility Name
Children's Hospital of Philadelphia - Main /ID# 232487
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4319
Country
United States
Individual Site Status
Recruiting
Facility Name
Frontier Clinical Research, LLC - Scottdale /ID# 231913
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683
Country
United States
Individual Site Status
Recruiting
Facility Name
Frontier Clinical Research /ID# 231912
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Pediatric Research /ID# 238616
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414-5834
Country
United States
Individual Site Status
Recruiting
Facility Name
Tribe Clinical Research LLC /ID# 230422
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607-4021
Country
United States
Individual Site Status
Recruiting
Facility Name
Premier Neurology, P.C. /ID# 227999
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Individual Site Status
Completed
Facility Name
Access Clinical Trials, Inc. /ID# 228002
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
BioBehavioral Research of Austin /ID# 230529
City
Austin
State/Province
Texas
ZIP/Postal Code
78759-5290
Country
United States
Individual Site Status
Recruiting
Facility Name
Tekton Research - Beaumont /ID# 231207
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77706-3067
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - Austin /ID# 230557
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613-3513
Country
United States
Individual Site Status
Recruiting
Facility Name
Relaro Medical Trials /ID# 239642
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedar Health Research /ID# 228003
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251-2202
Country
United States
Individual Site Status
Recruiting
Facility Name
3A Research - East El Paso /ID# 239193
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925-7945
Country
United States
Individual Site Status
Recruiting
Facility Name
Earle Research /ID# 231548
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research /ID# 229826
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Clinical Research Associates /ID# 244889
City
Houston
State/Province
Texas
ZIP/Postal Code
77090-2633
Country
United States
Individual Site Status
Recruiting
Facility Name
Sante Clinical Research /ID# 246503
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028-9640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
830-890-5171
Facility Name
FMC Science /ID# 231915
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Individual Site Status
Recruiting
Facility Name
Livingspring Family Medical Center /ID# 249869
City
Mansfield
State/Province
Texas
ZIP/Postal Code
76063-5622
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
(682) 404-5510
Facility Name
AIM Trials /ID# 230142
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Name
Road Runner Research /ID# 230527
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249-3538
Country
United States
Individual Site Status
Recruiting
Facility Name
Family Psychiatry of The Woodlands /ID# 230163
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Individual Site Status
Recruiting
Facility Name
ClinPoint Trials /ID# 230295
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165-1430
Country
United States
Individual Site Status
Recruiting
Facility Name
Pantheon Clinical Research /ID# 250703
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010-4968
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
385-281-0550
Facility Name
Highland Clinical Research /ID# 239362
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Individual Site Status
Recruiting
Facility Name
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Individual Site Status
Completed
Facility Name
Office of Maria Ona /ID# 234232
City
Franklin
State/Province
Virginia
ZIP/Postal Code
23851
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1901
Country
United States
Individual Site Status
Recruiting
Facility Name
National Clinical Research /ID# 231320
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Individual Site Status
Recruiting
Facility Name
Core Clinical Research /ID# 227904
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Name
Frontier Clinical Research - Kingwood /ID# 231914
City
Kingwood
State/Province
West Virginia
ZIP/Postal Code
26537-9797
Country
United States
Individual Site Status
Recruiting
Facility Name
Puerto Rico Health Institute /ID# 249162
City
Dorado
ZIP/Postal Code
00646
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
787-797-1049
Facility Name
GCM Medical Group PSC /ID# 249643
City
San Juan
ZIP/Postal Code
00917-3104
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
787-936-2100

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Learn more about this trial

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)

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