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:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT06806293
Eligibility Criteria:
Inclusion Criteria:
* History and eDiary confirmation have regular menstrual cycles within the range of 21 to 35 days in length (Note: menstrual cycle length is calculated as onset of menses until the day before the next onset of menses).
* History of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) for \>= 12 months prior to Visit 1/Screening.
* Migraine onset before age 50 years.
* By history at Visit 1/Screening, participant meets ICHD-3 criteria for pure menstrual migraine with or without aura, or menstrually-related migraine with or without aura, i.e., in at least 2 out of 3 cycles, experiences migraine attacks starting during the PMP (Day -2 to Day +3 relative to menses onset) in the opinion of the investigator.
* Participant records 3 perimenstrual periods (PMP) in the eDiary during the screening period, and in at least 2 of 3 PMPs the participant experiences and records a migraine attack in the eDiary with at least 1 migraine day.
Exclusion Criteria:
* History of an average of 15 or more headache days per month during the 3 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by International Classification of Headache Disorders, 3rd Edition (ICHD-3).
* An average of 15 or more headache days per month recorded in the eDiary during the screening period.
* History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
* Current diagnosis of new persistent daily headache, trigeminal autonomic cephalalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3.
* Required hospital/emergency room treatment for migraine attacks 3 or more times within 6 months prior to Visit 1/Screening.
* Presence of other confounding pain syndromes, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine per investigator judgment.
* Has a condition or situation, which the investigator feels will compromise the safety of the participant or the quality of the data and renders the subject an unsuitable candidate for the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06806293
Study Brief:
Protocol Section:
NCT06806293