Migraine Prevention Clinical Trial
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.
Study overview
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.
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.
Am I eligible?
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 taking part involves
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.
- 1
Enquiry & phone call
We call to explain the study and answer your questions.
- 2
Screening visit
Meet the team and have health checks to confirm eligibility.
- 3
Study visits
Regular visits with expert care and health monitoring.
- 4
Final visit & follow-up
A wrap-up check and a thank-you for helping research.
Still have questions?
Our team is happy to talk it through. Call 1300 742 326.
Frequently asked questions
A clinical trial is a research study involving volunteers that helps researchers evaluate new treatments, medications, medical devices or approaches to healthcare. Clinical trials help determine whether these interventions are safe, effective and appropriate for wider use.
Clinical trials help advance healthcare by showing how treatments work, identifying possible side effects and exploring new ways to prevent, diagnose and manage medical conditions. By taking part, volunteers contribute to knowledge that may benefit people in the future.
Each trial has its own eligibility criteria, which may relate to your age, medical history, health conditions or current medications. Some studies are for people with a specific condition, while others involve healthy volunteers. Our research team can help you understand whether a study may be suitable.
Participant safety and wellbeing are central to clinical research. In Australia, trials must meet strict ethical and regulatory requirements and are reviewed by a Human Research Ethics Committee (HREC). Participants are monitored throughout the study.
All clinical trials involve some uncertainty and level of risk. Before you decide, the research team will explain the known and potential risks, possible benefits and available alternatives.