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

NCT06848166 | Recruiting Early Phase 1

• 1 other identifier: MigraSquid1812
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Migraine Headache

Outcome Measures

Primary Outcomes (1)

• number of migraine days

  Change from baseline (during the screening period) in the number of migraine days over the previous 4 weeks, assessed at 3 months (12 weeks) post-surgery

  From previous 4 weeks before enrollment to the 3 months (12 weeks) post-surgery

Secondary Outcomes (17)

• The number of migraine days after surgery

  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

• The average number of migraine days

  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

• 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.

  From screening up to 12 months

• 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

  From surgery up 12 months (48 weeks) post-surgery

• 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.

  From surgery up 12 months (48 weeks) post-surgery

Study Arms (1)

Patients with chronic resistant migraine

EXPERIMENTAL

Device: liquid embolic agent SQUID 12, liquid embolic agent SQUID 18

Interventions

liquid embolic agent SQUID 12, liquid embolic agent SQUID 18 DEVICE

Total endovascular embolization of the frontal and parietal branches (less often the occipital branch) of the middle meningeal artery (MMA) with its complete devascularization. In the case of unilateral pain localization, ipsilateral MMA embolization will be performed; in the case of bilateral pain localization, total embolization of both MMA branches will be performed.

Patients with chronic resistant migraine

Eligibility Criteria

• Age: 35 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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).
• 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).

You may not qualify if:

• 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.
• 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.
• The patient is unable to distinguish a migraine headache from other types of headache.
• The patient has migraine complications, such as status migrainosus, persistent aura without infarction, migraine infarction, migraine aura (as a trigger for epileptic seizures).
• Body mass index (BMI) below 18.5 or above 39.9 kg/m².
• The onset of migraine was diagnosed at an age older than 50 years.
• The presence of metabolic syndrome or cachexia.
• 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.

Sponsors & Collaborators

• Vedanta University Clinic: lead

Study Sites (1)

Vedanta University Clinic

Bishkek, Gorod Bishkek, 720054, Kyrgyzstan

RECRUITING

Study Officials

• Andrey S Petrov, MD, PhD

  Vedanta Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrey E Petrov, MD, PhD

CONTACT

+996 707 207 428; doctorpetrovandrey@gmail.com

Andrey S Dakovskiy, MD

CONTACT

+972532786627; dakovskiyandrey@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: October 25, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

KY (1)