UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062560 |
|---|---|
| Receipt number | R000071611 |
| Scientific Title | A Prospective Observational Study of Atogepant Effectiveness in Routine Clinical Practice in Japan |
| Date of disclosure of the study information | 2026/08/12 |
| Last modified on | 2026/08/12 13:29:10 |
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Basic information
Public title
A Prospective Observational Study of Atogepant Effectiveness in Routine Clinical Practice in Japan
Acronym
CORNERSTONE-J
Scientific Title
A Prospective Observational Study of Atogepant Effectiveness in Routine Clinical Practice in Japan
Scientific Title:Acronym
CORNERSTONE-J
Region
| Japan |
Condition
Condition
Migraine
Classification by specialty
| Medicine in general | Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate patient-reported improvement with atogepant for the prevention of migraine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Achievement of a rating of "much better" or "very much better" at Week 12 as assessed by Patient Global Impression of Change (PGI-C)
Key secondary outcomes
1.Achievement of at least 50% reduction in monthly headache days at Weeks 1~4, 9~12, 21~24, 33~36 and 49~52.
2.Achievement of at least 50% reduction in monthly migraine days at Weeks 1~4, 9~12, 21~24, 33~36 and 49~52.
3.Change from baseline in the monthly headache days at Weeks 1~4, 9~12, 21~24, 33~36 and 49~52.
4.Change from baseline in the monthly migraine days at Weeks 1~4, 9~12, 21~24, 33~36 and 49~52.
5.Change from baseline in monthly moderate/severe headache days at Weeks 1~4, 9~12, 21~24, 33~36, and 49~52.
6.Change from baseline in the Headache Impact Test 6 (HIT6) total score at Weeks 4, 12, 24, 36 and 52.
7.Change from baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQv2.1) Role Function Restrictive (RFR) domain score at Weeks 4, 12, 24, 36 and 52.
8.Change from baseline in the Migraine Interictal Burden Scale (MIBS4) score at Weeks 4, 12, 24, 36 and 52.
9.Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Abilities Subset Short Form 6a Version 2.0 score at Weeks 4, 12, 24, 36 and 52.
10.Change from baseline in monthly acute medication use days at Weeks 1~4, 9~12, 21~24, 33~36 and 49~52.
11.Achievement of a rating of "satisfied" or "extremely satisfied" with atogepant at Weeks 4, 12, 24, 36 and 52, as assessed by the Patient Satisfaction with Study Medication (PSSM).
12.Achievement of a rating of "much better" or "very much better" as assessed by PGI-C at Weeks 4, 24, 36 and 52.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who are able to give voluntary informed consent before starting any study related assessments or procedures.
2.Patients who are aged >=15 at time of informed consent. If the patient is under 18 years old, a patient's parent or legal guardian must be willing to give written informed consent.
3.Patients who have at least 1 year history of migraine with or without aura consistent with a diagnosis according to the ICHD 3, 2018.
4.Patients being prescribed atogepant according to the label as migraine prevention.
5.For patients who initiate atogepant at the investigator discretion as part of their routine clinical care, the decision to administer atogepant must be made prior to and independent of recruitment into the study.
6.Patients who are able to collect monthly headache days during the last 28 days prior to atogepant for prevention
Key exclusion criteria
1.Patients who have any contraindications to atogepant for prevention as per labeling.
2.Patients who are pregnant or planning to be pregnant or women of childbearing potential not using contraception.
3.In the opinion of the investigator, the patient has a history or current evidence of any condition that might interfere with patient's ability to comply with the study requirements.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Takeshima |
Organization
Tominaga Hospital
Division name
Neurology
Zip code
556-0017
Address
1-4-48 Minatomachi, Naniwa-ku, Osaka-shi, Osaka
TEL
06-6568-1601
info@tominaga.or.jp
Public contact
Name of contact person
| 1st name | AbbVie GK Clinical Trial Registration Desk |
| Middle name | |
| Last name |
Organization
AbbVie GK
Division name
NA
Zip code
108-0023
Address
3-1-21 Shibaura, Minato-ku, Tokyo, Japan
TEL
03-4577-1111
Homepage URL
abbvie_jpn_info_clingov@abbvie.com
Sponsor or person
Institute
AbbVie GK
Institute
Department
Personal name
Funding Source
Organization
AbbVie GK
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
5-20-9-401 Mita, Minato-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a real world, prospective, single arm, post marking observational study. The population of this study is patients with diagnosis of Migraine commenced on Atogepant treatment prescribed as part of their routine clinical care at their clinician's discretion according to locally approved label and local treatment prescription recommendations/guidelines.
Management information
Registered date
| 2026 | Year | 08 | Month | 12 | Day |
Last modified on
| 2026 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071611
