search
Back to results

Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine (Release)

Primary Purpose

Migraine

Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Atogepant
Placebo for Atogepant
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, Episodic Migraine, Atogepant

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At least a 1-year history of migraine (with or without aura). Less than 50 years of age at the time of migraine onset. History of 4 to 14 migraine days per month in the 3 months prior to screening. 4 to 14 migraine days in the baseline period and completed at least 20 out of 28 days at the baseline period per the eDiary. Exclusion Criteria: Difficulty with distinguishing migraine headaches from tension-type or other headaches. Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Sites / Locations

  • Takanoko Hospital /ID# 245658Recruiting
  • Fukuiken Saiseikai Hospital /ID# 245662Recruiting
  • Jinnouchi Neurosurgical Clinic /ID# 245510Recruiting
  • Ikeda Neurosurgical Clinic /ID# 245881Recruiting
  • SUBARU Health Insurance Society Ota Memorial Hospital /ID# 247948Recruiting
  • Hiroshima City Hiroshima Citizens Hospital /ID# 246683Recruiting
  • Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 245667Recruiting
  • Nakamura Memorial Hospital /ID# 247379Recruiting
  • Konan Medical Center /ID# 245557Recruiting
  • Nishinomiya Municipal Central Hospital /ID# 246571Recruiting
  • Yamaguchi Clinic /ID# 246370Recruiting
  • Mito Kyodo General Hospital /ID# 245487Recruiting
  • Tsukuba Neurosurgery/Headache Clinic /ID# 254665Recruiting
  • Kijima Neurosurgery Clinic /ID# 245758Recruiting
  • Kanazawa Neurosurgical Hospital /ID# 254210Recruiting
  • Tokai University Hospital /ID# 245971Recruiting
  • Fujitsu Clinic /ID# 245811Recruiting
  • Atago Hospital /ID# 245818Recruiting
  • Umenotsuji Clinic /ID# 246103Recruiting
  • Saiseikai Kumamoto Hospital /Id# 253546Recruiting
  • Narikawa Neurological Clinic /ID# 254023Recruiting
  • Sendai Headache and Neurology Clinic Medical Corporation /ID# 245664Recruiting
  • Makabe Clinic /ID# 246621Recruiting
  • Okayama City General Medical Center /ID# 246007Recruiting
  • Gokeikai Osaka Kaisei Hospital /ID# 246623Recruiting
  • Chibune General Hospital /ID# 245973Recruiting
  • Tominaga Clinic /ID# 245812Recruiting
  • Takase Internal Medicine Clinic /ID# 245532Recruiting
  • Saitama Medical University Hospital /ID# 245663Recruiting
  • Saino Clinic /ID# 245921Recruiting
  • Japanese Red Cross Shizuoka Hospital /ID# 246204Recruiting
  • Dokkyo Medical University Hospital /ID# 246472Recruiting
  • Tokai University Hachioji Hospital /ID# 248326Recruiting
  • Kitasato University Kitasato Institute Hospital /ID# 246470Recruiting
  • Usuda Clinic Of Internal Medicine /ID# 246166Recruiting
  • Tokyo Headache Clinic /ID# 245486Recruiting
  • Keio University Hospital /ID# 245660Recruiting
  • Suzuki Kei Yasuragi Clinic /ID# 253493Recruiting
  • Sakura neuro Clinic /ID# 248320Recruiting
  • Nagaseki Headache Clinic /ID# 245485Recruiting
  • DOI Internal Medicine-Neurology Clinic /ID# 245661Recruiting
  • Tanaka Neurosurgical clinic /ID# 245488Recruiting
  • Tatsuoka Neurology Clinic /ID# 245328Recruiting
  • Ooba Clinic for Neurosurgery & Headache /ID# 246201Recruiting
  • Kokubu Clinic /ID# 245810Recruiting
  • Shinagawa Strings Clinic /ID# 245665Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Atogepant Dose A

Atogepant Dose B

Atogepant Dose C

Placebo

Arm Description

Participants will receive atogepant dose A once daily (QD) for 24 weeks.

Participants will receive atogepant dose B QD for 24 weeks.

Participants will receive atogepant dose C QD for 24 weeks.

Participants will receive placebo QD for 12 weeks. Participants will be re-randomized at week 12 to receive atogepant dose A, dose B or dose C QD 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 headache occurs which meets criteria listed, as per participant eDiary.

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 was used after the start of the headache, in which case no minimum duration will be specified.
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 Achieving At Least 50% Reduction in the 3-month Average of Monthly Migraine Days
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score
MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: Role Function Restrictive, Role Function Preventive, and Emotional Function domain. Participants respond to items using a 6-point scale ranging from "none of the time" to "all of the time." Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life.
Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D)
The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from "Not difficult at all" to "I could not do it at all." Scores range from 0-100 scale, with higher scores indicating greater impact of migraine.
Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D
The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from "Not difficult at all" to "I could not do it at all." Scores range from 0-100 scale, with higher scores indicating greater impact of migraine.

Full Information

First Posted
May 8, 2023
Last Updated
October 23, 2023
Sponsor
AbbVie
search

1. Study Identification

Unique Protocol Identification Number
NCT05861427
Brief Title
Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine
Acronym
Release
Official Title
A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With An Active Treatment Extension to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Subjects With Episodic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2023 (Actual)
Primary Completion Date
January 24, 2025 (Anticipated)
Study Completion Date
May 28, 2025 (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.
Yes
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. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed. Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 45 sites across Japan. Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, dose B or dose C for 12 additional weeks. All participants will be followed for 30 days following last dose of study drug. 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, Episodic Migraine, Atogepant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atogepant Dose A
Arm Type
Experimental
Arm Description
Participants will receive atogepant dose A once daily (QD) for 24 weeks.
Arm Title
Atogepant Dose B
Arm Type
Experimental
Arm Description
Participants will receive atogepant dose B QD for 24 weeks.
Arm Title
Atogepant Dose C
Arm Type
Experimental
Arm Description
Participants will receive atogepant dose C QD for 24 weeks.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants will receive placebo QD for 12 weeks. Participants will be re-randomized at week 12 to receive atogepant dose A, dose B or dose C QD for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Atogepant
Other Intervention Name(s)
Qulipta
Intervention Description
Oral Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo for 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 headache occurs which meets criteria listed, as per participant eDiary.
Time Frame
Up to 12 Weeks
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 was used after the start of the headache, in which case no minimum duration will be specified.
Time Frame
Up to 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
Up to Week 12
Title
Percentage of Participants Achieving At Least 50% Reduction in the 3-month Average of Monthly Migraine Days
Description
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
Time Frame
Up to Week 12
Title
Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score
Description
MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: Role Function Restrictive, Role Function Preventive, and Emotional Function domain. Participants respond to items using a 6-point scale ranging from "none of the time" to "all of the time." Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life.
Time Frame
Up to Week 12
Title
Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D)
Description
The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from "Not difficult at all" to "I could not do it at all." Scores range from 0-100 scale, with higher scores indicating greater impact of migraine.
Time Frame
Up to Week 12
Title
Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D
Description
The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from "Not difficult at all" to "I could not do it at all." Scores range from 0-100 scale, with higher scores indicating greater impact of migraine.
Time Frame
Up to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least a 1-year history of migraine (with or without aura). Less than 50 years of age at the time of migraine onset. History of 4 to 14 migraine days per month in the 3 months prior to screening. 4 to 14 migraine days in the baseline period and completed at least 20 out of 28 days at the baseline period per the eDiary. Exclusion Criteria: Difficulty with distinguishing migraine headaches from tension-type or other headaches. Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
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
Takanoko Hospital /ID# 245658
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
790-0925
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuiken Saiseikai Hospital /ID# 245662
City
Fukui-shi
State/Province
Fukui
ZIP/Postal Code
918-8503
Country
Japan
Individual Site Status
Recruiting
Facility Name
Jinnouchi Neurosurgical Clinic /ID# 245510
City
Kasuga-shi
State/Province
Fukuoka
ZIP/Postal Code
816-0802
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ikeda Neurosurgical Clinic /ID# 245881
City
Kasuga-shi
State/Province
Fukuoka
ZIP/Postal Code
816-0824
Country
Japan
Individual Site Status
Recruiting
Facility Name
SUBARU Health Insurance Society Ota Memorial Hospital /ID# 247948
City
Ota-shi
State/Province
Gunma
ZIP/Postal Code
373-8585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hiroshima City Hiroshima Citizens Hospital /ID# 246683
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Individual Site Status
Recruiting
Facility Name
Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 245667
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0003
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nakamura Memorial Hospital /ID# 247379
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8570
Country
Japan
Individual Site Status
Recruiting
Facility Name
Konan Medical Center /ID# 245557
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
658-0064
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nishinomiya Municipal Central Hospital /ID# 246571
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8014
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamaguchi Clinic /ID# 246370
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8204
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mito Kyodo General Hospital /ID# 245487
City
Mito-shi
State/Province
Ibaraki
ZIP/Postal Code
310-0015
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tsukuba Neurosurgery/Headache Clinic /ID# 254665
City
Tsukuba-shi
State/Province
Ibaraki
ZIP/Postal Code
305-0822
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kijima Neurosurgery Clinic /ID# 245758
City
Kahoku-gun
State/Province
Ishikawa
ZIP/Postal Code
929-0342
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanazawa Neurosurgical Hospital /ID# 254210
City
Nonoichi-shi
State/Province
Ishikawa
ZIP/Postal Code
921-8841
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokai University Hospital /ID# 245971
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fujitsu Clinic /ID# 245811
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
211-8588
Country
Japan
Individual Site Status
Recruiting
Facility Name
Atago Hospital /ID# 245818
City
Kochi-shi
State/Province
Kochi
ZIP/Postal Code
780-0051
Country
Japan
Individual Site Status
Recruiting
Facility Name
Umenotsuji Clinic /ID# 246103
City
Kochi-shi
State/Province
Kochi
ZIP/Postal Code
780-8011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saiseikai Kumamoto Hospital /Id# 253546
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
861-4101
Country
Japan
Individual Site Status
Recruiting
Facility Name
Narikawa Neurological Clinic /ID# 254023
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
981-3126
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sendai Headache and Neurology Clinic Medical Corporation /ID# 245664
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
982-0014
Country
Japan
Individual Site Status
Recruiting
Facility Name
Makabe Clinic /ID# 246621
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-0964
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama City General Medical Center /ID# 246007
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8557
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gokeikai Osaka Kaisei Hospital /ID# 246623
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
532-0003
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chibune General Hospital /ID# 245973
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
555-0034
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tominaga Clinic /ID# 245812
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5560015
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takase Internal Medicine Clinic /ID# 245532
City
Toyonaka-shi
State/Province
Osaka
ZIP/Postal Code
560-0012
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical University Hospital /ID# 245663
City
Iruma-gun
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saino Clinic /ID# 245921
City
Tokorozawa-shi
State/Province
Saitama
ZIP/Postal Code
359-1141
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Shizuoka Hospital /ID# 246204
City
Shizuoka-shi
State/Province
Shizuoka
ZIP/Postal Code
420-0853
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dokkyo Medical University Hospital /ID# 246472
City
Shimotsuga-gun
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokai University Hachioji Hospital /ID# 248326
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
192-0032
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitasato University Kitasato Institute Hospital /ID# 246470
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Individual Site Status
Recruiting
Facility Name
Usuda Clinic Of Internal Medicine /ID# 246166
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
156-0043
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Headache Clinic /ID# 245486
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
151-0051
Country
Japan
Individual Site Status
Recruiting
Facility Name
Keio University Hospital /ID# 245660
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Suzuki Kei Yasuragi Clinic /ID# 253493
City
Tachikawa-shi
State/Province
Tokyo
ZIP/Postal Code
190-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sakura neuro Clinic /ID# 248320
City
Toyama City
State/Province
Toyama
ZIP/Postal Code
930-0803
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagaseki Headache Clinic /ID# 245485
City
Kai-shi
State/Province
Yamanashi
ZIP/Postal Code
400-0124
Country
Japan
Individual Site Status
Recruiting
Facility Name
DOI Internal Medicine-Neurology Clinic /ID# 245661
City
Hiroshima
ZIP/Postal Code
730-0031
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tanaka Neurosurgical clinic /ID# 245488
City
Kagoshima
ZIP/Postal Code
892-0844
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tatsuoka Neurology Clinic /ID# 245328
City
Kyoto
ZIP/Postal Code
600-8811
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ooba Clinic for Neurosurgery & Headache /ID# 246201
City
Oita-shi
ZIP/Postal Code
8700831
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kokubu Clinic /ID# 245810
City
Takamatsu
ZIP/Postal Code
769-0103
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shinagawa Strings Clinic /ID# 245665
City
Tokyo
ZIP/Postal Code
108-0075
Country
Japan
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=M22-056
Description
Related Info

Learn more about this trial

Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine

We'll reach out to this number within 24 hrs