Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07451769
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent has been obtained prior to the initiation of any study-specific procedures.
2. Age ≥18 years at the time of screening.
3. History of migraine without aura for at least 12 months prior to screening, with a frequency of 1-5 migraine attacks per month, based on medical records and/or patient self-report, and diagnosed in accordance with the ICHD-3 criteria.
Exclusion Criteria:
1. History of any other primary headache disorder, except for tension-type headache with \<5 headache days per month, based on ICHD-3 classification.
2. History of any secondary headache disorder, per ICHD-3 criteria, prior to screening.
3. Use of prophylactic migraine medication within 30 days or within 5 plasma half-lives (whichever is longer) prior to screening.
4. Previous use of any therapies targeting the CGRP signaling pathway, including anti-CGRP ligand monoclonal antibodies, anti-CGRP receptor monoclonal antibodies, or small molecule CGRP receptor antagonists.
5. Known risk of self-harm or harm to others, including a history of suicidal behavior.
6. Any clinically significant disorder, condition, or disease (other than those permitted in the protocol) that, in the opinion of the investigator, could compromise participant safety or interfere with study procedures or data integrity.
7. Positive urine pregnancy test at screening or on Day 1 in female participants of childbearing potential.
8. Pregnancy or breastfeeding, or plans to become pregnant or breastfeed during the study period.
9. Evidence of current pregnancy or breastfeeding based on self-report or medical records.
10. Inability or unwillingness to complete all protocol-required visits and procedures, or concerns regarding protocol adherence, as judged by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07451769
Study Brief:
Protocol Section:
NCT07451769