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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 59
Healthy Volunteers: f
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• 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).

Locations
Other Locations
Kyrgyzstan
Vedanta University Clinic
RECRUITING
Bishkek
Contact Information
Primary
Andrey E Petrov, MD, PhD
doctorpetrovandrey@gmail.com
+996 707 207 428
Backup
Andrey S Dakovskiy, MD
dakovskiyandrey@gmail.com
+972532786627
Time Frame
Start Date: 2024-10-25
Estimated Completion Date: 2027-05
Participants
Target number of participants: 30
Treatments
Experimental: Patients with chronic resistant migraine
Related Therapeutic Areas
Sponsors
Leads: Vedanta University Clinic

This content was sourced from clinicaltrials.gov