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:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT05211050
Eligibility Criteria:
Inclusion Criteria:
1. Participant has provided informed consent prior to initiation of any study-specific activities/procedures.
2. Age ≥18 years upon entry into screening.
3. History of migraine without aura for ≥12 months with a frequency of 1-5 migraine attacks per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.
Exclusion Criteria:
1. History of any primary headache disorder other than migraine without aura, or tension-type headache with a frequency of ≥5 headache days per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.
2. History of any secondary headache disorder before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report.
3. Any headache 48 hours prior to, or any migraine 72 hours prior to the start of the experiment on day 1 and 2.
4. Daily consumption of any drug/medication other than oral contraception (birth control).
5. Intake of prophylactic migraine medication within ≤30 days or 5 plasma half-lives (whichever is longer) prior to screening.
6. The participant is at risk of self-harm or harm to others as evidenced by past suicidal behavior.
7. History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator will pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
8. Female participants of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
9. Female participants who are pregnant or breastfeeding or plan to become pregnant or breastfeed during participation in the study.
10. Evidence of current pregnancy or breastfeeding per participant self-report or medical records.
11. Participants likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participants' and investigator's knowledge.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05211050
Study Brief:
Protocol Section:
NCT05211050