Investigational treatment for frequent migraines.

Study Information:

Migraine is a common and disabling condition that can have a major impact on daily life. Although several preventive treatments are available, many people continue to experience frequent migraine attacks or do not get enough relief from current medications, highlighting the need for new treatment options. Researchers are therefore investigating new approaches that target different pathways involved in migraines to potentially help improve future treatment options.

This clinical research trial is evaluating an investigational oral medication designed to target a pathway involved in inflammation and pain signalling that is thought to contribute to migraines. The study aims to assess the safety and effectiveness of the investigational medication and identify the most appropriate dose for future research.

Who is it for?

You may be eligible to participate if you:

• Are 18 to 64 years old
• Have a diagnosis of migraine (with or without aura)
• Experience frequent migraines
• Have not taken preventive migraine medication for at least 3 months
• Have not received Botox treatment within the last 4 months
• Have previously tried up to 4 preventive migraine medications
• Are willing to use effective contraception (if applicable) during the study and for 90 days after the last dose

Please note: Additional eligibility criteria apply. The study team will discuss these with interested participants during the screening process.

What does study participation look like?

If eligible, participation in the study will last approximately 21 weeks.

The study includes a 4-week screening and observation period, during which participants will complete a daily electronic headache diary to determine whether they meet the study eligibility criteria. Eligible participants will then be randomly assigned to receive either the investigational oral medication or a placebo, which they will take orally twice a day.

Participants will be required to attend 7 clinic visits throughout the study. During these visits, the study team will monitor participants' health and migraine symptoms. Study procedures may include physical examinations, blood and urine tests, ECGs, vital signs measurements, medical history reviews, a daily headache diary, and other health assessments.

Clinic visits will take place during business hours of 9am–5pm, Monday–Friday. The length of each visit may vary depending on the assessments required at that stage of the study.

If you experience frequent migraine attacks and would like to contribute to research, we invite you to register your interest to find out whether this study may be suitable for you. Participants who take part in the study will receive reimbursement for reasonable travel expenses and time associated with attending study visits.