Study of the Effectiveness and Safety of Embolization of the Middle Meningeal Artery Using Non-ad… (NCT06848166) | Clinical Trial Compass
RecruitingEarly Phase 1
Study of the Effectiveness and Safety of Embolization of the Middle Meningeal Artery Using Non-adhesive Materials SQUID 12 and SQUID 18 in the Treatment of Patients With Chronic Resistant Migraine
Kyrgyzstan30 participantsStarted 2024-10-25
Plain-language summary
To evaluate the effectiveness and safety of middle meningeal artery (MMA) embolization using non-adhesive materials SQUID 12 and SQUID 18 as a treatment method for patients with chronic resistant migraine.
Who can participate
Age range
35 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The patient has read, understood, signed, and dated the Patient Information Sheet with the informed consent form.
. The patient is aged between 35 and 59 years inclusive at the time of signing the Patient Information Sheet with the informed consent form.
. The diagnosis of "chronic migraine" according to the clinical guidelines on migraine by the Ministry of Health of the Russian Federation (2021) / ICD-10 (2018), established at least 12 months before screening.
. Resistant nature of the migraine, determined by the doctor using the criteria of the European Headache Federation (EHF, 2020), established at least 6 months before screening.
. At least 14 days of headache during the screening period (28 days), of which 8 days of headache meet the definition of migraine (assessed based on the results of filling out the Headache Diary for 28 days during the screening period).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
number of migraine days
Timeframe: From previous 4 weeks before enrollment to the 3 months (12 weeks) post-surgery
. Migraine, resistant to both pharmacological and non-pharmacological prevention and treatment methods, in the patient's history.
. Maximum level of headache during migraine days above 5 points (inclusive) on a 10-point numerical rating scale during the screening period.
. No positive effect on migraine symptoms (frequency and intensity of headache attacks) from previous botulinum toxin therapy (administration of OnabotulinumtoxinA, Relatox® (botulinum toxin type A - hemagglutinin complex 155 - 195 IU, administered every 12 weeks according to the PREEMPT protocol).
Exclusion criteria
. The patient has contraindications to undergoing embolization of the middle meningeal artery based on the medical history, results of examinations, and laboratory tests conducted during screening.
. Allergic reactions to contrast agents used during procedures before/during the embolization procedure and associated procedures.
. The patient has a history of cerebral vascular malformations, arteriovenous malformations, brain aneurysms, brain tumors, hydrocephalus, arachnoiditis, cerebrospinal fluid circulation disorders, craniovertebral junction anomalies, platybasia, skull base deformities, severe traumatic brain injuries, stenosis, and occlusion of pre-cerebral arteries.
. The patient has a history of skull base fractures and consequences of skull base fractures, history of neurosurgical operations.
. A history of mental illness (including depression, confirmed by a psychiatrist during screening through the HADS questionnaire and Hamilton scale assessment), which, in the opinion of the psychiatrist, may affect the patient's ability to assess their condition, interfere with participation in the study, or impact the patient's safety during the study.
. A history of hyperthyroidism or diabetes. The presence of other endocrine disorders in the patient's history that, in the doctor's opinion, could interfere with participation in the study or affect the evaluation of efficacy and/or safety.
. History or data of drug addiction, alcoholism, or abuse of medications.
. Medication-induced headache at the time of screening and within 3 months (12 weeks) prior to screening.