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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT03308968
Eligibility Criteria:
Inclusion Criteria:
* The participant has a diagnosis of migraine with onset at ≤50 years of age.
* Body weight ≥45 kilograms.
* The participant has a history of migraine for ≥12 months prior to screening.
* Women of childbearing potential (WOCBP) whose male partners are potentially fertile (that is; no vasectomy) must use highly effective birth control methods for the duration of the study and the follow-up period and for 6.0 months after discontinuation of investigational medicinal product (IMP)
* Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically \[that is; vasectomy\] or congenitally sterile) and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of the study and for 6.0 months after discontinuation of the investigational medicinal product (IMP).
* Additional criteria apply, please contact the investigator for more information.
Exclusion Criteria:
* At the time of screening visit, participant is receiving any preventive migraine medications, regardless of the medical indication for more than 5 days and expects to continue with these medications.
* Participant has received onabotulinumtoxinA for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 3 months before screening visit.
* The participant has used an intervention/device (for example; scheduled nerve blocks and transcranial magnetic stimulation) for migraine during the 2 months prior to screening.
* The participant uses triptans/ergots as preventive therapies for migraine.
* Participant uses non-steroidal anti-inflammatory drugs (NSAIDs) as preventive therapy for migraine on nearly daily basis for other indications. Note: Low dose aspirin (for example; 81 mg) used for cardiovascular disease prevention is allowed.
* Additional criteria apply, please contact the investigator for more information.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03308968
Study Brief:
Protocol Section:
NCT03308968