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Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)

Primary Purpose

Migraine

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
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

Eligibility Criteria

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

Inclusion Criteria:

  • Completers of the lead-in Study 3110-305-002 (in the main study or PK cohort) or those who screen failed due to being placebo responders.
  • Demonstrated an acceptable degree of compliance with study procedures in the lead-in study and who, in the investigator's clinical judgment, did not experience an AE that may indicate an unacceptable safety risk for this study.

Exclusion Criteria:

  • 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.
  • An ECG with clinically significant abnormalities at Visit 1 as determined by the investigator.
  • Clinically significant abnormalities in physical examination at Visit 1, as determined by the investigator.
  • Significant risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator; participants should be excluded if they report suicidal ideation with intent, with or without a plan (ie, Type 4 or 5 on the C-SSRS), or report suicidal behavior at Visit 1
  • Any medical or other reason (eg, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study) that, in the investigator's opinion, might indicate that the participant is unsuitable for the study.

Sites / Locations

  • Rehabilitation & Neurological Services /ID# 240054
  • The Center for Clinical Trials - Saraland /ID# 239448
  • Preferred Research Partners /ID# 238979
  • Advanced Research Center /ID# 238967
  • Neuro Pain Medical Center /ID# 239135
  • Sunwise Clinical Research /ID# 238458
  • Alliance for Research - Long Beach /ID# 233497
  • Children's Hospital Los Angeles /ID# 239446
  • Excell Research, Inc /ID# 233495
  • Rady Children's Hospital San Diego /ID# 248334
  • Lumos Clinical Research Center /ID# 239018
  • Pacific Clinical Research Management Group /ID# 238503
  • Children's Hospital Colorado /ID# 239838
  • IMMUNOe Research Centers /ID# 240846
  • MCB Clinical Research Centers /ID# 240999
  • Emerson Clinical Research Inst /ID# 238455
  • Encore Medical Research of Boynton Beach LLC /ID# 248720
  • Gulfcoast Clinical Research Center /ID# 233335
  • Sarkis Clinical Trials /ID# 233493
  • Northwest Florida Clinical Research Group, LLC /ID# 244396
  • A.G.A Clinical Trials /ID# 238409
  • Encore Medical Research LLC /ID# 247463
  • Advanced Research Institute of Miami /ID# 240712
  • Auzmer Research /ID# 241514
  • Columbus Clinical Services, Llc /Id# 238968
  • Biotech Pharmaceutical Group /ID# 239020
  • Neurology & Pain Medicine /ID# 241860
  • Suncoast Clinical Research /ID# 233535
  • Medical Research Group of Central Florida /ID# 240711
  • Bioresearch Institute LLC /ID# 238408
  • South Florida Urgent Care - Pembroke Pines /ID# 241139
  • Asclepes Research Centers - Spring Hill /ID# 231872
  • University of South Florida /ID# 233420
  • Encore Medical Research of Weston LLC /ID# 248335
  • Pediatric Neurology PA /ID# 233336
  • Treken Primary Care /ID# 243504
  • Rare Disease Research, LLC /ID# 238833
  • Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 238852
  • Coastal Georgia Child Neurology /ID# 240845
  • iResearch Atlanta, LLC /ID# 239832
  • Meridian Clinical Research LLC /ID# 231873
  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 238454
  • Velocity Clinical Research - Boise /ID# 238978
  • Accellacare /ID# 238490
  • College Park Family Care Center Overland Park /ID# 240707
  • Psychiatric Associates /ID# 240710
  • Alliance for Multispecialty Research (AMR) - Wichita West /ID# 239829
  • University of Kentucky Chandler Medical Center /ID# 233428
  • Pharmasite Research, Inc. /ID# 233414
  • NeuroBehavioral Medicine Group /ID# 238410
  • Minneapolis Clinic of Neurology - Burnsville /ID# 238828
  • MediSync Clinical Research Hattiesburg Clinic /ID# 239837
  • Headache Neurology Research Institute /ID# 240974
  • Sharlin Health Neuroscience Research Center /ID# 238969
  • Cognitive Clinical Trials (CCT) - Papillion /ID# 239835
  • Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 239441
  • Hunterdon Neurology /ID# 248222
  • Goryeb Children's Hospital /ID# 239425
  • CVS HealthHUB - Runnemede /ID# 240057
  • Dent Neurosciences Research Center, Inc. /ID# 238415
  • Bioscience Research /ID# 239442
  • North Suffolk Neurology /ID# 238457
  • SUNY Upstate Medical University /ID# 241140
  • CVS HealthHUB - Charlotte /ID# 240842
  • OnSite Clinical Solutions, LLC - Hickory /ID# 238946
  • Patient Priority Clinical Sites, LLC /ID# 240051
  • University of Cincinnati /ID# 238461
  • Cincinnati Childrens Hospital Medical Center /ID# 247491
  • Headache Center of Hope /ID# 244819
  • Aventiv Research Columbus /ID# 238832
  • CincyScience /ID# 233334
  • IPS Research Company /ID# 231876
  • Providence Pediatric Neurology - St. Vincent /ID# 240050
  • Children's Hospital of Philadelphia - Main /ID# 241138
  • Frontier Clinical Research, LLC - Scottdale /ID# 239017
  • Frontier Clinical Research /ID# 238502
  • Coastal Pediatric Research /ID# 240708
  • Tribe Clinical Research LLC /ID# 239143
  • Premier Neurology, P.C. /ID# 233419
  • Memphis Neurology - Germantown /ID# 250769
  • Access Clinical Trials, Inc. /ID# 238414
  • UT Health Austin at Dell Children's Neurology Clinic /ID# 246570
  • BioBehavioral Research of Austin /ID# 233427
  • Tekton Research - Beaumont /ID# 238407
  • Velocity Clinical Research - Austin /ID# 233406
  • Relaro Medical Trials /ID# 241141
  • Cedar Health Research /ID# 233403
  • 3A Research - East El Paso /ID# 241665
  • Earle Research /ID# 238940
  • DM Clinical Research /ID# 238361
  • Houston Clinical Research Associates /ID# 246522
  • Sante Clinical Research /ID# 248333
  • FMC Science /ID# 240475
  • Livingspring Family Medical Center /ID# 252194
  • AIM Trials /ID# 233425
  • Road Runner Research /ID# 238360
  • Family Psychiatry of The Woodlands /ID# 238980
  • ClinPoint Trials /ID# 238406
  • Pantheon Clinical Research /ID# 251475
  • Highland Clinical Research /ID# 240053
  • University of Utah School of Medicine /ID# 239021
  • Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 240055
  • Office of Maria Ona /ID# 239833
  • Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 239142
  • National Clinical Research /ID# 238419
  • Core Clinical Research /ID# 233421
  • Frontier Clinical Research - Kingwood /ID# 238459
  • Puerto Rico Health Institute /ID# 250560
  • Ponce Medical School Foundation /ID# 251372
  • GCM Medical Group PSC /ID# 250561

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ubrogepant Dose A (12 to 17 Years Old)

Ubrogepant Dose B (6 to 11 Years Old)

Arm Description

Participants will receive oral tablets of ubrogepant Dose A 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 any intensity.

Participants will receive the highest dose of oral tablets of ubrogepant tested in Study 3110-305-002 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 any intensity.

Outcomes

Primary Outcome Measures

Percentage of Participants with Adverse Events (AEs)
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 Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)
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 Potentially Clinically Significant Vital Sign Parameters
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Percentage of Participants with Potentially Clinically Significant lab values
Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Percentage of with Participants with Suicidal Ideation or Suicidal Behavior
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt).
Percentage of Participants with Change in Menstrual Cycle
Female participants who have entered menarche are to be asked for the date of the first and last day of their most recent menstrual period.
Change from baseline in Tanner staging score
Tanner's staging is used to assess growth and pubertal development.
Change From baseline in Behavior Rating Inventory of Executive Function (BRIEF 2) questionnaire
The BRIEF 2 is an 86-item questionnaire assessing executive function. It consists of 2 indexes, Behavioral Regulation and Metacognition, which are then used to calculate an overall composite score. Higher scores indicate more executive difficulties

Secondary Outcome Measures

Full Information

First Posted
November 9, 2021
Last Updated
January 18, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05127954
Brief Title
Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)
Official Title
A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability 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
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
March 9, 2027 (Anticipated)
Study Completion Date
March 9, 2027 (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 long term safety and tolerability of ubrogepant in the acute treatment of migraine in pediatric participants. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Pediatric participants (aged 6-17 years) with a history of migraine will be enrolled. Participants who completed the lead-in Study 3110-305-002, as well as those who were placebo responders and screen failed, will be eligible to enroll into this study. Around 1200 participants will be enrolled in the study at approximately 120 sites in the United States. Participants may receive ubrogepant oral tables to treat up to 8 migraine attacks of any intensity per month. There will be an option to take a second dose of study intervention (identical to initial dose), or rescue medication, starting 2 hours after the initial dose. The study duration will be up to 54 weeks. 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 safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events 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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ubrogepant Dose A (12 to 17 Years Old)
Arm Type
Experimental
Arm Description
Participants will receive oral tablets of ubrogepant Dose A 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 any intensity.
Arm Title
Ubrogepant Dose B (6 to 11 Years Old)
Arm Type
Experimental
Arm Description
Participants will receive the highest dose of oral tablets of ubrogepant tested in Study 3110-305-002 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 any intensity.
Intervention Type
Drug
Intervention Name(s)
Ubrogepant
Other Intervention Name(s)
Ubrelvy
Intervention Description
Oral Tablet
Primary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AEs)
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 54 weeks
Title
Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)
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 54 Weeks
Title
Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters
Description
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Time Frame
Up to 54 Weeks
Title
Percentage of Participants with Potentially Clinically Significant lab values
Description
Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Time Frame
Up to 54 Weeks
Title
Percentage of with Participants with Suicidal Ideation or Suicidal Behavior
Description
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt).
Time Frame
Up to 54 Weeks
Title
Percentage of Participants with Change in Menstrual Cycle
Description
Female participants who have entered menarche are to be asked for the date of the first and last day of their most recent menstrual period.
Time Frame
Up to 54 Weeks
Title
Change from baseline in Tanner staging score
Description
Tanner's staging is used to assess growth and pubertal development.
Time Frame
Up to 54 Weeks
Title
Change From baseline in Behavior Rating Inventory of Executive Function (BRIEF 2) questionnaire
Description
The BRIEF 2 is an 86-item questionnaire assessing executive function. It consists of 2 indexes, Behavioral Regulation and Metacognition, which are then used to calculate an overall composite score. Higher scores indicate more executive difficulties
Time Frame
up to 54 weeks

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: Completers of the lead-in Study 3110-305-002 (in the main study or PK cohort) or those who screen failed due to being placebo responders. Demonstrated an acceptable degree of compliance with study procedures in the lead-in study and who, in the investigator's clinical judgment, did not experience an AE that may indicate an unacceptable safety risk for this study. Exclusion Criteria: 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. An ECG with clinically significant abnormalities at Visit 1 as determined by the investigator. Clinically significant abnormalities in physical examination at Visit 1, as determined by the investigator. Significant risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator; participants should be excluded if they report suicidal ideation with intent, with or without a plan (ie, Type 4 or 5 on the C-SSRS), or report suicidal behavior at Visit 1 Any medical or other reason (eg, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study) that, in the investigator's opinion, might indicate that the participant is unsuitable for the study.
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# 240054
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805-4046
Country
United States
Facility Name
The Center for Clinical Trials - Saraland /ID# 239448
City
Saraland
State/Province
Alabama
ZIP/Postal Code
36571
Country
United States
Facility Name
Preferred Research Partners /ID# 238979
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Advanced Research Center /ID# 238967
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Neuro Pain Medical Center /ID# 239135
City
Fresno
State/Province
California
ZIP/Postal Code
93710-5473
Country
United States
Facility Name
Sunwise Clinical Research /ID# 238458
City
Lafayette
State/Province
California
ZIP/Postal Code
94549-4579
Country
United States
Facility Name
Alliance for Research - Long Beach /ID# 233497
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Children's Hospital Los Angeles /ID# 239446
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Excell Research, Inc /ID# 233495
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Rady Children's Hospital San Diego /ID# 248334
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Lumos Clinical Research Center /ID# 239018
City
San Jose
State/Province
California
ZIP/Postal Code
95124-4108
Country
United States
Facility Name
Pacific Clinical Research Management Group /ID# 238503
City
Upland
State/Province
California
ZIP/Postal Code
91786-3676
Country
United States
Facility Name
Children's Hospital Colorado /ID# 239838
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
IMMUNOe Research Centers /ID# 240846
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
MCB Clinical Research Centers /ID# 240999
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Emerson Clinical Research Inst /ID# 238455
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
Encore Medical Research of Boynton Beach LLC /ID# 248720
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33436-7245
Country
United States
Facility Name
Gulfcoast Clinical Research Center /ID# 233335
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Sarkis Clinical Trials /ID# 233493
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Northwest Florida Clinical Research Group, LLC /ID# 244396
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561-4495
Country
United States
Facility Name
A.G.A Clinical Trials /ID# 238409
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Encore Medical Research LLC /ID# 247463
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021-6476
Country
United States
Facility Name
Advanced Research Institute of Miami /ID# 240712
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030-4613
Country
United States
Facility Name
Auzmer Research /ID# 241514
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33813-2768
Country
United States
Facility Name
Columbus Clinical Services, Llc /Id# 238968
City
Miami
State/Province
Florida
ZIP/Postal Code
33125-5114
Country
United States
Facility Name
Biotech Pharmaceutical Group /ID# 239020
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Neurology & Pain Medicine /ID# 241860
City
Miami
State/Province
Florida
ZIP/Postal Code
33186-7661
Country
United States
Facility Name
Suncoast Clinical Research /ID# 233535
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Medical Research Group of Central Florida /ID# 240711
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Bioresearch Institute LLC /ID# 238408
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026-4383
Country
United States
Facility Name
South Florida Urgent Care - Pembroke Pines /ID# 241139
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029-2818
Country
United States
Facility Name
Asclepes Research Centers - Spring Hill /ID# 231872
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609-5692
Country
United States
Facility Name
University of South Florida /ID# 233420
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Encore Medical Research of Weston LLC /ID# 248335
City
Weston
State/Province
Florida
ZIP/Postal Code
33331-3642
Country
United States
Facility Name
Pediatric Neurology PA /ID# 233336
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789-7111
Country
United States
Facility Name
Treken Primary Care /ID# 243504
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30315
Country
United States
Facility Name
Rare Disease Research, LLC /ID# 238833
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318-2512
Country
United States
Facility Name
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 238852
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Coastal Georgia Child Neurology /ID# 240845
City
Brunswick
State/Province
Georgia
ZIP/Postal Code
31520-1601
Country
United States
Facility Name
iResearch Atlanta, LLC /ID# 239832
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Meridian Clinical Research LLC /ID# 231873
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 238454
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Velocity Clinical Research - Boise /ID# 238978
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Accellacare /ID# 238490
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
College Park Family Care Center Overland Park /ID# 240707
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210-2761
Country
United States
Facility Name
Psychiatric Associates /ID# 240710
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66221
Country
United States
Facility Name
Alliance for Multispecialty Research (AMR) - Wichita West /ID# 239829
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205-1138
Country
United States
Facility Name
University of Kentucky Chandler Medical Center /ID# 233428
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Pharmasite Research, Inc. /ID# 233414
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
NeuroBehavioral Medicine Group /ID# 238410
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Facility Name
Minneapolis Clinic of Neurology - Burnsville /ID# 238828
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337-6732
Country
United States
Facility Name
MediSync Clinical Research Hattiesburg Clinic /ID# 239837
City
Petal
State/Province
Mississippi
ZIP/Postal Code
39465-2932
Country
United States
Facility Name
Headache Neurology Research Institute /ID# 240974
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
Sharlin Health Neuroscience Research Center /ID# 238969
City
Ozark
State/Province
Missouri
ZIP/Postal Code
65721-5315
Country
United States
Facility Name
Cognitive Clinical Trials (CCT) - Papillion /ID# 239835
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046-4131
Country
United States
Facility Name
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 239441
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060-3483
Country
United States
Facility Name
Hunterdon Neurology /ID# 248222
City
Annandale
State/Province
New Jersey
ZIP/Postal Code
08801-3127
Country
United States
Facility Name
Goryeb Children's Hospital /ID# 239425
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
CVS HealthHUB - Runnemede /ID# 240057
City
Runnemede
State/Province
New Jersey
ZIP/Postal Code
08078-1034
Country
United States
Facility Name
Dent Neurosciences Research Center, Inc. /ID# 238415
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Bioscience Research /ID# 239442
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549-3028
Country
United States
Facility Name
North Suffolk Neurology /ID# 238457
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776-3387
Country
United States
Facility Name
SUNY Upstate Medical University /ID# 241140
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
CVS HealthHUB - Charlotte /ID# 240842
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210-8905
Country
United States
Facility Name
OnSite Clinical Solutions, LLC - Hickory /ID# 238946
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Patient Priority Clinical Sites, LLC /ID# 240051
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215-2123
Country
United States
Facility Name
University of Cincinnati /ID# 238461
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cincinnati Childrens Hospital Medical Center /ID# 247491
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Headache Center of Hope /ID# 244819
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236-1875
Country
United States
Facility Name
Aventiv Research Columbus /ID# 238832
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
CincyScience /ID# 233334
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
IPS Research Company /ID# 231876
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
Providence Pediatric Neurology - St. Vincent /ID# 240050
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225-6652
Country
United States
Facility Name
Children's Hospital of Philadelphia - Main /ID# 241138
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4319
Country
United States
Facility Name
Frontier Clinical Research, LLC - Scottdale /ID# 239017
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683
Country
United States
Facility Name
Frontier Clinical Research /ID# 238502
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Coastal Pediatric Research /ID# 240708
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414-5834
Country
United States
Facility Name
Tribe Clinical Research LLC /ID# 239143
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607-4021
Country
United States
Facility Name
Premier Neurology, P.C. /ID# 233419
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Memphis Neurology - Germantown /ID# 250769
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138-1751
Country
United States
Facility Name
Access Clinical Trials, Inc. /ID# 238414
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
UT Health Austin at Dell Children's Neurology Clinic /ID# 246570
City
Austin
State/Province
Texas
ZIP/Postal Code
78723-3079
Country
United States
Facility Name
BioBehavioral Research of Austin /ID# 233427
City
Austin
State/Province
Texas
ZIP/Postal Code
78759-5290
Country
United States
Facility Name
Tekton Research - Beaumont /ID# 238407
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77706-3067
Country
United States
Facility Name
Velocity Clinical Research - Austin /ID# 233406
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613-3513
Country
United States
Facility Name
Relaro Medical Trials /ID# 241141
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Cedar Health Research /ID# 233403
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251-2202
Country
United States
Facility Name
3A Research - East El Paso /ID# 241665
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925-7945
Country
United States
Facility Name
Earle Research /ID# 238940
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Facility Name
DM Clinical Research /ID# 238361
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Houston Clinical Research Associates /ID# 246522
City
Houston
State/Province
Texas
ZIP/Postal Code
77090-2633
Country
United States
Facility Name
Sante Clinical Research /ID# 248333
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028-9640
Country
United States
Facility Name
FMC Science /ID# 240475
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Livingspring Family Medical Center /ID# 252194
City
Mansfield
State/Province
Texas
ZIP/Postal Code
76063-5622
Country
United States
Facility Name
AIM Trials /ID# 233425
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Road Runner Research /ID# 238360
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249-3538
Country
United States
Facility Name
Family Psychiatry of The Woodlands /ID# 238980
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
ClinPoint Trials /ID# 238406
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165-1430
Country
United States
Facility Name
Pantheon Clinical Research /ID# 251475
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010-4968
Country
United States
Facility Name
Highland Clinical Research /ID# 240053
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
University of Utah School of Medicine /ID# 239021
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-0002
Country
United States
Facility Name
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 240055
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
Office of Maria Ona /ID# 239833
City
Franklin
State/Province
Virginia
ZIP/Postal Code
23851
Country
United States
Facility Name
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 239142
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1901
Country
United States
Facility Name
National Clinical Research /ID# 238419
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Core Clinical Research /ID# 233421
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Frontier Clinical Research - Kingwood /ID# 238459
City
Kingwood
State/Province
West Virginia
ZIP/Postal Code
26537-9797
Country
United States
Facility Name
Puerto Rico Health Institute /ID# 250560
City
Dorado
ZIP/Postal Code
00646
Country
Puerto Rico
Facility Name
Ponce Medical School Foundation /ID# 251372
City
Ponce
ZIP/Postal Code
00716-0377
Country
Puerto Rico
Facility Name
GCM Medical Group PSC /ID# 250561
City
San Juan
ZIP/Postal Code
00917-3104
Country
Puerto Rico

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

Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)

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