Early Phase 1 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:

• The person has read, understood, signed, and dated the consent and information forms for the study.
• The person is between 35 and 59 years old at the time of signing the consent form.
• The person has been diagnosed with chronic migraine (according to specific Russian and international diagnostic guidelines) for at least 12 months before the screening period.
• The person's migraines have been classified by their doctor as "resistant" (difficult to treat) using European Headache Federation criteria, established at least 6 months before screening.
• During the 28-day screening period, the person had at least 14 days of headache, with at least 8 of those days meeting the definition of a migraine, as recorded in a headache diary.
• The person has a history of migraine that has not responded to both medication-based and non-medication-based prevention and treatment approaches.
• During migraine days in the screening period, the maximum headache pain level was 5 or higher on a 10-point scale.
• Previous treatment with botulinum toxin (specifically OnabotulinumtoxinA or Relatox®, given every 12 weeks under the PREEMPT protocol) did not improve the frequency or intensity of migraine attacks.
• The person agrees to use appropriate contraception and not donate eggs or sperm from the time of signing the consent form until the end of the study (applies to women who are able to become pregnant and to men).

Who may not be able to join:

• People who have medical reasons why they cannot safely undergo a procedure to block a specific artery in the head (middle meningeal artery embolization), based on their medical history or screening test results.
• People who have had allergic reactions to contrast dye (the liquid used to help doctors see blood vessels during procedures).
• People who have a history of certain brain or blood vessel conditions, including blood vessel malformations, brain aneurysms, brain tumours, fluid circulation problems in the brain, skull base deformities, severe head injuries, or narrowing/blockage of arteries leading to the brain.
• People who have had a skull base fracture or its lasting effects, or who have previously had brain or skull surgery.
• People with a history of mental illness — including depression confirmed by a psychiatrist during screening — that in the psychiatrist's opinion could affect the person's ability to assess their own condition, interfere with participation, or affect their safety.
• People with a history of an overactive thyroid (hyperthyroidism) or diabetes, or other hormonal/endocrine disorders that in the doctor's opinion could interfere with the study.
• People with a history of drug addiction, alcoholism, or misuse of medications.
• People who had headaches caused by overuse of medication at the time of screening or within the 3 months before screening.
• People who have had other specific types of chronic headache within the 12 months before screening, including cluster headaches, new daily persistent headache, certain nerve pain conditions, retinal migraine, migraine without headache, hemiplegic migraine, or certain types of raised or lowered pressure in the brain, among others.
• People who are unable to tell the difference between a migraine and other types of headache.
• People who have experienced migraine complications such as a prolonged migraine attack that will not stop (status migrainosus), a long-lasting aura, a stroke caused by migraine, or migraine aura that triggers epileptic seizures.
• People whose Body Mass Index (BMI) is below 18.5 or above 39.9 (a measure of weight relative to height).
• People whose migraines were first diagnosed after the age of 50.
• People with metabolic syndrome or a condition involving significant muscle and fat loss (cachexia).
• People with serious heart or circulation conditions, currently or in the past, including severe heart failure, significant abnormal heart rhythms, significant heart valve disease, very high blood pressure that cannot be controlled, blood clots in the lungs, or deep vein blood clots.
• People with varicose veins in the legs or a history of blood clots in the leg veins.
• People with coronary artery disease or hardening of the heart's arteries.
• People with a history of significant narrowing of the arteries that supply blood to the head and neck.
• People who have had a stroke or its lasting effects.
• People who are currently pregnant or plan to become pregnant within the next 3 months.
• People with irregular heart rhythm (atrial fibrillation), a hole between the chambers of the heart (patent foramen ovale), other heart wall abnormalities, or a history of heart or coronary artery surgery.
• People with a history of blood clotting disorders or antiphospholipid syndrome (a condition that increases clotting risk), or signs of clotting problems found during screening.
• People who have used blood-thinning medications within 5 days before the procedure.
• People with uncontrolled asthma or severe chronic lung disease.
• People with reduced kidney function identified during screening or in their medical history (confirm with trial site for specific threshold details).
• People with a history of liver problems or elevated liver enzyme levels found during screening.
• People with a history of widespread body pain conditions such as fibromyalgia.
• Women who are using combined oral contraceptive pills and have a history of blood clots anywhere in the body.
• People with a history of epilepsy, seizure disorders, or neurological conditions other than migraine.
• People who test positive for HIV, hepatitis B, hepatitis C, or syphilis, either based on medical history or blood tests done during screening.
• People with a history of cancer within the 5 years before screening, or a current or suspected cancer diagnosis.
• People with other serious, unstable, or significant medical or psychological conditions that, in the doctor's opinion, could interfere with participation or affect how results are assessed.
• People who have taken part in another interventional clinical trial within 30 days before screening, or who plan to join another interventional trial during this study (participation in non-interventional registry or observation studies is allowed).
• People who are unable to read or write, or are unwilling or unable to follow the study procedures, or have any other condition that in the doctor's opinion would prevent safe or proper participation.
• Employees of the medical institution running the study or of the sponsoring company, their family members, or anyone in a dependent relationship with those employees.

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