Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062560) titled 'A Prospective Observational Study of Atogepant Effectiveness in Routine Clinical Practice in Japan' on Aug. 12.
Study Type:
Observational
Primary Sponsor:
Institute - AbbVie GK
Condition:
Condition - Migraine
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate patient-reported improvement with atogepant for the prevention of migraine.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 15
years-old
=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 Size - 400
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 26 Day
Anticipated trial start date - 2026 Year 11 Month 15 Day
Last follow-up date - 2029 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071611
Disclaimer: Curated by HT Syndication.