Phase 2 Migraine Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 70 years old.
• People who weigh at least 40 kg and have a body mass index (BMI) of 18.0 or above.
• People who have had migraines (with or without aura) for at least 12 months before screening, where migraines first started at age 50 or younger.
• People who have had at least 12 migraine headache days across the 3 months before screening.
• During a 4-week tracking period before the study starts, people who have between 4 and 14 migraine headache days per month, with at least 4 of those days meeting specific migraine definitions (confirm with trial site for full details).
• People who have a condition called medication overuse headache (MOH) may still be eligible.
• People who have tried at least 2 different types of standard migraine prevention medications without success, from different medication classes.
• People who have not yet tried an anti-CGRP therapy (a newer class of migraine treatment) — referred to in the trial as "aCGRP-naive" participants — may be considered for the group that has not previously used this type of treatment.
• People who have previously tried at least one anti-CGRP therapy for migraine prevention but it did not work — referred to as "aCGRP-inadequate responders" — may be considered for the other group.
• People who are able to tell the difference between their migraine headaches and tension-type headaches.
• Women who are not pregnant, not planning to become pregnant during the study, and not breastfeeding. Women who could become pregnant and are sexually active with a male partner who has not been sterilised must use two highly effective forms of contraception throughout the study, and must avoid egg donation or IVF from signing the consent form until 10 weeks after the last dose of the study treatment.

Who may not be able to join:

• People who have had certain specific types of migraine, including hemiplegic migraine (sporadic or familial), ophthalmoplegic migraine, or basilar-type migraine.
• People who have had a headache disorder other than migraine in the 3 months before screening.
• People with a history of severe allergic reactions, or known allergy to vaccines or immunoglobulins (antibody-based medicines).
• People with a significant psychiatric (mental health) condition that could affect their safety or the reliability of the study results.
• People with a significant ongoing illness affecting the heart, nervous system, lungs, liver, kidneys, digestive system, immune system, hormones, or metabolism (confirm with trial site for details).
• People who have had cancer within the last 5 years before screening, with some exceptions such as certain non-spreading skin cancers or early-stage cervical or prostate conditions (confirm with trial site).
• People with a known history of drug or alcohol misuse within the past year, or who test positive for drugs or alcohol at screening.
• People with a history of a specific heart rhythm abnormality (QT interval over 450 milliseconds, or over 470 milliseconds for those aged 65 or older) that caused them to stop taking a medication.
• People with an inherited heart rhythm condition called congenital long or short QT syndrome.
• People with certain heart rhythm problems that cause symptoms or require treatment, including uncontrolled atrial fibrillation or a type of fast heart rhythm called ventricular tachycardia (people with atrial fibrillation that is controlled with medication may still be eligible).
• People who have used migraine prevention medications within 30 days (or 5 half-lives of that medication, whichever is longer) before screening or during the study.
• People in the "aCGRP-naive" group who have previously used any anti-CGRP therapy for migraine treatment or prevention at any time.
• People who have used opioids or barbiturate-containing pain medications more than twice per month on average in the 6 months before screening.
• People who have received botulinum toxin injections (such as Botox) in the head, face, or neck for any reason in the 4 months before screening.
• People who have used a nerve block, transcranial magnetic stimulation, or similar device-based migraine treatment within 2 months of screening.
• People using prescription or non-prescription medications, vitamins, or supplements that have not been stable for at least 3 months, or that may interfere with the study (confirm with trial site).
• People who need treatment with another biological medicine (including intravenous immunoglobulin) during the study. Previous use of a biological medicine may be acceptable if it was used more than 3 months or 5 half-lives before screening, whichever is longer.
• People who have received a live vaccine fewer than 30 days before the study starts, or an inactivated vaccine (such as flu or COVID-19) fewer than 14 days before the study starts.
• People who have taken part in another clinical trial involving an experimental treatment or device within 3 months or 5 half-lives of that treatment before screening, whichever is longer.
• People with a known allergy to the study drug MEDI0618 or any of its ingredients.

Important: Always verify eligibility with the trial site directly before applying.