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A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine

Primary Purpose

Episodic Migraine

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

About this trial

This is an interventional treatment trial for Episodic Migraine focused on measuring Episodic Migraine, Atogepant, QULIPTA, AGN-241689

Eligibility Criteria

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

Inclusion Criteria: Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs). History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months. Participant has to have 4 to 14 migraine days and < 15 headache days in the 28-day baseline period per eDiary. To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine and per investigator judgment is appropriate to receive preventive treatment for migraine. Exclusion Criteria: History of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018). Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018). Have a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018). Have required in-hospital (excluding emergency department visits) treatment for migraine 3 or more times in the 6 months prior to Visit 1.

Sites / Locations

  • Rehabilitation & Neurological Services /ID# 248517Recruiting
  • Preferred Research Partners /ID# 249729Recruiting
  • Advanced Research Center /ID# 251381Recruiting
  • Sunwise Clinical Research /ID# 248529Recruiting
  • Alliance for Research - Long Beach /ID# 248521Recruiting
  • Excell Research, Inc /ID# 247532Recruiting
  • Lumos Clinical Research Center /ID# 249731Recruiting
  • Advanced Neurosciences Research, LLC /ID# 247592Recruiting
  • Northwest Florida Clinical Research Group, LLC /ID# 251382Recruiting
  • Advanced Research Institute of Miami /ID# 248539Recruiting
  • My Preferred Research LLC /ID# 249720Recruiting
  • Asclepes Research Centers - Spring Hill /ID# 248525Recruiting
  • Coastal Georgia Child Neurology /ID# 249733Recruiting
  • Deaconess Clinic - Gateway Health Center /ID# 247589Recruiting
  • College Park Family Care Center Overland Park /ID# 249734Recruiting
  • Michigan Headache & Neurological Institute (MHNI) /ID# 247468Recruiting
  • Cognitive Clinical Trials (CCT) - Papillion /ID# 248536Recruiting
  • Goryeb Children's Hospital /ID# 249724Recruiting
  • Dent Neurosciences Research Center, Inc. /ID# 248534Recruiting
  • Headache Wellness Center /ID# 251018Recruiting
  • Patient Priority Clinical Sites, LLC /ID# 247535Recruiting
  • CincyScience /ID# 249726Recruiting
  • Lynn Health Science Institute (LHSI) /ID# 247600Recruiting
  • Access Clinical Trials, Inc. /ID# 248532Recruiting
  • FutureSearch Trials of Neurology /ID# 247470Recruiting
  • 3A Research - East El Paso /ID# 248516Recruiting
  • Earle Research /ID# 248501Recruiting
  • Family Psychiatry of The Woodlands /ID# 249727Recruiting
  • ClinPoint Trials /ID# 248540Recruiting
  • Pantheon Clinical Research /ID# 251601Recruiting
  • Highland Clinical Research /ID# 247590Recruiting
  • Office of Maria Ona /ID# 249738Recruiting
  • Core Clinical Research /ID# 249721Recruiting
  • Puerto Rico Health Institute /ID# 249741Recruiting
  • Caribbean Medical Research Center /ID# 251634Recruiting

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

Experimental

Experimental

Experimental

Experimental

Arm Label

Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)

Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)

Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)

Double-Blind Treatment Period: Placebo (12-17 yrs)

Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)

Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)

Double-Blind Treatment Period: Placebo (6-11 yrs)

Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)

Arm Description

Participants aged 6 to 11 will receive oral tablets of atogepant Dose A to determine appropriate dose for the 6-11 year old group in double-blind treatment period.

Participants aged 6 to 11 will receive oral tablets of atogepant Dose B to determine appropriate dose for the 6-11 year old group in double-blind treatment period.

Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.

Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.

Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.

Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.

Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.

Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.

Outcomes

Primary Outcome Measures

Change from Baseline in Mean Monthly Migraine Days
A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM.

Secondary Outcome Measures

Change from Baseline in Mean Monthly Headache Days
A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication (e.g., ibuprofen, triptan) was used after the start of the headache, in which case no minimum duration will be specified. Calendar days begin at midnight and last until 11:59 PM.
Change from Baseline in Mean Monthly Acute Medication Use Days
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.
Percentage of Participants who Achieve at least a 50% Reduction in Average of Monthly Migraine Days
A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM.
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) total score
The PedsQL is a 23-item measure that evaluates quality of life in four areas of functioning: physical, emotional, social, and school functioning. The PedsQL yields a total quality of life score and two summary scores: Physical Health Summary Score and Psychosocial Health Summary Score.
Change from baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) total score
The PedMIDAS scale evaluates the impact of headache on school performance, disability at home and social/sport function. The score is a composite of the total of 6 questions.

Full Information

First Posted
January 26, 2023
Last Updated
September 25, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05711394
Brief Title
A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine
Official Title
A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
March 30, 2028 (Anticipated)
Study Completion Date
May 9, 2028 (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
A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with episodic migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites. Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of 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
Episodic Migraine
Keywords
Episodic Migraine, Atogepant, QULIPTA, AGN-241689

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)
Arm Type
Experimental
Arm Description
Participants aged 6 to 11 will receive oral tablets of atogepant Dose A to determine appropriate dose for the 6-11 year old group in double-blind treatment period.
Arm Title
Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)
Arm Type
Experimental
Arm Description
Participants aged 6 to 11 will receive oral tablets of atogepant Dose B to determine appropriate dose for the 6-11 year old group in double-blind treatment period.
Arm Title
Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)
Arm Type
Experimental
Arm Description
Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.
Arm Title
Double-Blind Treatment Period: Placebo (12-17 yrs)
Arm Type
Experimental
Arm Description
Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
Arm Title
Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)
Arm Type
Experimental
Arm Description
Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.
Arm Title
Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)
Arm Type
Experimental
Arm Description
Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.
Arm Title
Double-Blind Treatment Period: Placebo (6-11 yrs)
Arm Type
Experimental
Arm Description
Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
Arm Title
Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)
Arm Type
Experimental
Arm Description
Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Atogepant
Other Intervention Name(s)
QULIPTA, AGN-241689
Intervention Description
Oral Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo-Matching Atogepant
Intervention Description
Oral Tablet
Primary Outcome Measure Information:
Title
Change from Baseline in Mean Monthly Migraine Days
Description
A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM.
Time Frame
Baseline (Week 0) through Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline in Mean Monthly Headache Days
Description
A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication (e.g., ibuprofen, triptan) was used after the start of the headache, in which case no minimum duration will be specified. Calendar days begin at midnight and last until 11:59 PM.
Time Frame
Baseline (Week 0) through Week 12
Title
Change from Baseline in Mean Monthly Acute Medication Use Days
Description
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.
Time Frame
Baseline (Week 0) through Week 12
Title
Percentage of Participants who Achieve at least a 50% Reduction in Average of Monthly Migraine Days
Description
A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM.
Time Frame
Baseline (Week 0) to 3 Months
Title
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) total score
Description
The PedsQL is a 23-item measure that evaluates quality of life in four areas of functioning: physical, emotional, social, and school functioning. The PedsQL yields a total quality of life score and two summary scores: Physical Health Summary Score and Psychosocial Health Summary Score.
Time Frame
Baseline (Week 0) through Week 12
Title
Change from baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) total score
Description
The PedMIDAS scale evaluates the impact of headache on school performance, disability at home and social/sport function. The score is a composite of the total of 6 questions.
Time Frame
Baseline (Week 0) through Week 12

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: Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs). History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months. Participant has to have 4 to 14 migraine days and < 15 headache days in the 28-day baseline period per eDiary. To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine and per investigator judgment is appropriate to receive preventive treatment for migraine. Exclusion Criteria: History of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018). Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018). Have a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018). Have required in-hospital (excluding emergency department visits) treatment for migraine 3 or more times in the 6 months 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# 248517
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805-4046
Country
United States
Individual Site Status
Recruiting
Facility Name
Preferred Research Partners /ID# 249729
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Research Center /ID# 251381
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Recruiting
Facility Name
Sunwise Clinical Research /ID# 248529
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# 248521
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Individual Site Status
Recruiting
Facility Name
Excell Research, Inc /ID# 247532
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
760-758-2222
Facility Name
Lumos Clinical Research Center /ID# 249731
City
San Jose
State/Province
California
ZIP/Postal Code
95124-4108
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Neurosciences Research, LLC /ID# 247592
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Florida Clinical Research Group, LLC /ID# 251382
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561-4495
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
850.934.1299
Facility Name
Advanced Research Institute of Miami /ID# 248539
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030-4613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
305-246-0001
Facility Name
My Preferred Research LLC /ID# 249720
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Asclepes Research Centers - Spring Hill /ID# 248525
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609-5692
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
352-364-9401
Facility Name
Coastal Georgia Child Neurology /ID# 249733
City
Brunswick
State/Province
Georgia
ZIP/Postal Code
31520-1601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
770-376-7912
Facility Name
Deaconess Clinic - Gateway Health Center /ID# 247589
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
812-474-7184
Facility Name
College Park Family Care Center Overland Park /ID# 249734
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210-2761
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Headache & Neurological Institute (MHNI) /ID# 247468
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104-5131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
734-677-6000
Facility Name
Cognitive Clinical Trials (CCT) - Papillion /ID# 248536
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046-4131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
402-979-8770
Facility Name
Goryeb Children's Hospital /ID# 249724
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Name
Dent Neurosciences Research Center, Inc. /ID# 248534
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
716-558-5670
Facility Name
Headache Wellness Center /ID# 251018
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Individual Site Status
Recruiting
Facility Name
Patient Priority Clinical Sites, LLC /ID# 247535
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215-2123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
513-791-7760
Facility Name
CincyScience /ID# 249726
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
513-229-7585
Facility Name
Lynn Health Science Institute (LHSI) /ID# 247600
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
405-447-8839
Facility Name
Access Clinical Trials, Inc. /ID# 248532
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
FutureSearch Trials of Neurology /ID# 247470
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Name
3A Research - East El Paso /ID# 248516
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925-7945
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
915-598-8888
Facility Name
Earle Research /ID# 248501
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
281-218-8080
Facility Name
Family Psychiatry of The Woodlands /ID# 249727
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Individual Site Status
Recruiting
Facility Name
ClinPoint Trials /ID# 248540
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165-1430
Country
United States
Individual Site Status
Recruiting
Facility Name
Pantheon Clinical Research /ID# 251601
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
385-281-8351
Facility Name
Highland Clinical Research /ID# 247590
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Individual Site Status
Recruiting
Facility Name
Office of Maria Ona /ID# 249738
City
Franklin
State/Province
Virginia
ZIP/Postal Code
23851
Country
United States
Individual Site Status
Recruiting
Facility Name
Core Clinical Research /ID# 249721
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Name
Puerto Rico Health Institute /ID# 249741
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
Caribbean Medical Research Center /ID# 251634
City
San Juan
ZIP/Postal Code
00918-3501
Country
Puerto Rico
Individual Site Status
Recruiting

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.abbvieclinicaltrials.com/study/?id=M21-201
Description
Related Info

Learn more about this trial

A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine

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