Clinical trial NCT06848166: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Chronic Migraine Headache
Lead sponsor: Vedanta University Clinic
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. The patient has read, understood, signed, and dated the Patient Information Sheet with the informed consent form.
2. The patient is aged between 35 and 59 years inclusive at the time of signing the Patient Information Sheet with the informed consent form.
3. 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.
4. 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.
5. 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).
6. Migraine, resistant to both pharmacological and non-pharmacological prevention and treatment methods, in the patient's history.
7. Maximum level of headache during migraine days above 5 points (inclusive) on a 10-point numerical rating scale during the screening period.
8. 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).
9. Consent to use adequate contraceptive methods\* and not serve as an egg/sperm donor from the time of signing the Patient Information Sheet with the informed consent form for participation in the study until the end of the study (for women with reproductive potential and men).

Exclusion Criteria:

1. 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.
2. Allergic reactions to contrast agents used during procedures before/during the embolization procedure and associated procedures.
3. 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.
4. The patient has a history of skull base fractures and consequences of skull base fractures, history of neurosurgical operations.
5. 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.
6. 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.
7. History or data of drug addiction, alcoholism, or abuse of medications.
8. Medication-induced headache at the time of screening and within 3 months (12 weeks) prior to screening.
9. Other types of chronic headache in the patient's history within less than 12 months before screening, such as trigeminal autonomic cephalalgias (including cluster headaches, prolonged hemicrania), new daily persistent headaches, painful cranial neuropathies, retinal migraine, aura without headache, hemiplegic migraine, brainstem aura migraine, idiopathic intracranial hypertension without optic nerve edema, spontaneous intracranial hypertension, secondary headaches.
10. The patient is unable to distinguish a migraine headache from other types of headache.
11. The patient has migraine complications, such as status migrainosus, persistent aura without infarction, migraine infarction, migraine aura (as a trigger for epileptic seizures).
12. Body mass index (BMI) below 18.5 or above 39.9 kg/m².
13. The onset of migraine was diagnosed at an age older than 50 years.
14. The presence of metabolic syndrome or cachexia.
15. Severe cardiovascular diseases currently or in the past, including: chronic heart failure class III or IV (according to the New York Heart Association classification), clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), significant heart valve diseases, uncontrolled hypertension with systolic blood pressure \> 180 mm Hg and diastolic blood pressure \> 110 mm Hg, pulmonary embolism, or deep vein thrombosis.
16. Varicose veins of the lower limbs, history of lower limb vein thrombosis.
17. Ischemic heart disease, atherosclerosis of coronary vessels.
18. Stenotic atherosclerosis of brachiocephalic arteries in the patient's history.
19. Acute cerebrovascular accident or its consequences in the patient's history.
20. The patient is pregnant or plans to become pregnant within the next 3 months.
21. Atrial fibrillation, patent foramen ovale, anomalies of the interatrial septum, history of heart and coronary vessel surgeries.
22. Signs of blood clotting disorders in the patient's history and screening, history of antiphospholipid syndrome.
23. Use of anticoagulant drugs less than 5 days before the procedure.
24. Uncontrolled bronchial asthma, severe chronic obstructive pulmonary disease in the patient's history.
25. Renal insufficiency at screening based on the calculation of glomerular filtration rate (GFR) ≤ 60 mL/min, based on serum creatinine levels at screening, or a history of renal insufficiency.
26. History of liver insufficiency, elevated ALT and AST levels at screening.
27. History of generalized pain syndrome, fibromyalgia.
28. For women: use of combined oral contraceptives with a history of thrombosis of any localization.
29. History of epilepsy, epileptic syndrome, seizure disorders, neurological conditions other than the primary condition (migraine).
30. Presence of antibodies to HIV, hepatitis C virus, hepatitis B surface antigen (HbsAg), antibodies to T. Pallidum, or a history of HIV infection, hepatitis B, hepatitis C, or syphilis, either in the medical history or based on the results of serological blood tests at screening.
31. Malignant neoplasms within 5 years before screening, or current or suspected oncological disease.
32. Other serious, unstable, decompensated, or clinically significant medical or psychological conditions that, in the opinion of the doctor, may interfere with the patient's participation in the study or affect the evaluation of efficacy and/or safety.
33. Participation in other interventional clinical trials, including the study completion visit, within 30 days prior to the screening, or planning to participate in such studies during the current study. Participation in non-interventional registry or epidemiological studies is allowed.
34. The patient is unable to read or write, unwilling or unable to comply with the study protocol procedures; any other conditions that, in the opinion of the doctor, may prevent participation in the study, adherence to procedures, or contradict the patient's interests, as well as affect the study results.
35. Employees of the medical institution conducting the study or the sponsor company, their family members, or subjects in dependent relationships.

Primary outcomes:
measure: number of migraine days
timeFrame: From previous 4 weeks before enrollment to the 3 months (12 weeks) post-surgery
Secondary outcomes:
measure: The number of migraine days after surgery
timeFrame: From surgery up to 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery
measure: The average number of migraine days
timeFrame: From treatment every 12-week period, assessed at visits 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery
measure: Change from baseline (during the screening period) in the number of migraine days over the previous 4 weeks, assessed at 1 month (4 weeks), 2 months (8 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery.
timeFrame: From screening up to 12 months
measure: The number of headache days over the previous 4 weeks at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery
timeFrame: From surgery up 12 months (48 weeks) post-surgery
measure: The average number of headache days over a 4-week period, calculated for the preceding 12-week period, assessed at visits 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) post-surgery.
timeFrame: From surgery up 12 months (48 weeks) post-surgery
measure: Change compared to the baseline level (during the screening period) of the number of days with headaches in the previous 4 weeks, assessed at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12
timeFrame: From screening up to 12 months
measure: The proportion of patients whose number of migraine days in the previous 4 weeks decreases by 50% or more from the baseline level
timeFrame: From surgery up 12 months (48 weeks) post-surgery
measure: The proportion of patients whose average number of migraine days over the previous 12 weeks decreases by 50% or more
timeFrame: From screening up to 12 months
measure: The proportion of patients whose number of headache days in the previous 4 weeks decreases by 50% or more from the baseline level
timeFrame: From screening up to 12 months
measure: The number of days with headache intensity rated as "moderate" or "severe" in the previous 4 weeks
timeFrame: From surgery up 12 months (48 weeks) post-surgery
measure: The average number of days in the previous 12-week period with headache intensity rated as "moderate" or "severe,"
timeFrame: From surgery up 12 months (48 weeks) post-surgery
measure: Change compared to the baseline level in the number of days with headache intensity rated as "moderate" or "severe" in the previous 4 weeks
timeFrame: From surgery up 12 months (48 weeks) post-surgery
measure: The maximum intensity of migraine headache in the previous 4 weeks, as determined by the patient using a 10-point numerical rating scale
timeFrame: From surgery up 6 months (24 weeks) post-surgery
measure: The number of days with symptoms associated with migraine (nausea, vomiting, photophobia, phonophobia) in the previous 4 weeks
timeFrame: From surgery up 6 months (24 weeks) post-surgery
measure: The total score on the HIT-6 scale
timeFrame: From surgery up 12 months (48 weeks) post-surgery
measure: The total score on the MIDAS scale
timeFrame: From surgery up 12 months (48 weeks) post-surgery
measure: Change in the total score on the HIT-6 scale
timeFrame: From surgery up 12 months (48 weeks) post-surgery
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: Vedanta University Clinic
Study officials:
affiliation: Vedanta Clinic
name: Andrey S Petrov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: