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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic resistant migraine | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of migraine days after surgery | The number of migraine 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 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrey E Petrov, MD, PhD | Contact | +996 707 207 428 | doctorpetrovandrey@gmail.com | |
| Andrey S Dakovskiy, MD | Contact | +972532786627 | dakovskiyandrey@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrey S Petrov, MD, PhD | Vedanta Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vedanta University Clinic | Recruiting | Bishkek | Bishkek | 720054 | Kyrgyzstan |
Decision on IPD sharing is in progress
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| The average number of migraine days | The average number of migraine 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 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. | 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 | 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. | 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 |
| 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 | 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 months (48 weeks) after the surgery. | From screening up to 12 months |
| The proportion of patients whose number of migraine days in the previous 4 weeks decreases by 50% or more from the baseline level | The proportion of patients whose number of migraine days in the previous 4 weeks decreases by 50% or more from the baseline level (during the screening period) 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) after the surgery. | From surgery up 12 months (48 weeks) post-surgery |
| The proportion of patients whose average number of migraine days over the previous 12 weeks decreases by 50% or more | The proportion of patients whose average number of migraine days over the previous 12 weeks decreases by 50% or more at the visit at 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) after the surgery, compared to the baseline level (during the screening period). | From screening up to 12 months |
| The proportion of patients whose number of headache days in the previous 4 weeks decreases by 50% or more from the baseline level | The proportion of patients whose number of headache days in the previous 4 weeks decreases by 50% or more from the baseline level (during the screening period) 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) after the surgery. | From screening up to 12 months |
| The number of days with headache intensity rated as "moderate" or "severe" in the previous 4 weeks | The number of days with headache intensity rated as "moderate" or "severe" in 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) after the surgery (according to the Clinical Trial Guidelines for Chronic Migraine Prevention, 2018). | From surgery up 12 months (48 weeks) post-surgery |
| The average number of days in the previous 12-week period with headache intensity rated as "moderate" or "severe," | The average number of days in the previous 12-week period with headache intensity rated as "moderate" or "severe," calculated and assessed at visits at 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) after the surgery. | From surgery up 12 months (48 weeks) post-surgery |
| Change compared to the baseline level in the number of days with headache intensity rated as "moderate" or "severe" in the previous 4 weeks | Change compared to the baseline level in the number of days with headache intensity rated as "moderate" or "severe" in the previous 4 weeks, calculated 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) after the surgery. | From surgery up 12 months (48 weeks) post-surgery |
| The maximum intensity of migraine headache in the previous 4 weeks, as determined by the patient using a 10-point numerical rating scale | The maximum intensity of migraine headache in the previous 4 weeks, as determined by the patient using a 10-point numerical rating scale, assessed at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), and 6 months (24 weeks) after the surgery. | From surgery up 6 months (24 weeks) post-surgery |
| The number of days with symptoms associated with migraine (nausea, vomiting, photophobia, phonophobia) in the previous 4 weeks | The number of days with symptoms associated with migraine (nausea, vomiting, photophobia, phonophobia) in the previous 4 weeks, assessed at 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), and 6 months (24 weeks) after the surgery. | From surgery up 6 months (24 weeks) post-surgery |
| The total score on the HIT-6 scale | The total score on the HIT-6 scale at 1 month (4 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) after the surgery. | From surgery up 12 months (48 weeks) post-surgery |
| The total score on the MIDAS scale | The total score on the MIDAS scale at 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), and 12 months (48 weeks) after the surgery. | From surgery up 12 months (48 weeks) post-surgery |
| Change in the total score on the HIT-6 scale | Change in the total score on the HIT-6 scale 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) after the surgery compared to the baseline level. | From surgery up 12 months (48 weeks) post-surgery |