Chronic Migraine HeadacheCHROMENCT06848166
CHROnic Migraine Embolization
A study testing liquid embolic agent SQUID 12, liquid embolic agent SQUID 18 in people with Chronic Migraine Headache, run by Vedanta University Clinic at 1 site in Kyrgyzstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Chronic Migraine Headache
- What is being tested?
- liquid embolic agent SQUID 12, liquid embolic agent SQUID 18
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- 17 Oct 2024to May 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has read, understood, signed, and dated the Patient Information Sheet with the informed consent form.
- The patient is aged between 21 and 70 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.
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- 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).
Who cannot join
- 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.
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- 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.
- Varicose veins of the lower limbs, history of lower limb vein thrombosis.
- Ischemic heart disease, atherosclerosis of coronary vessels.
- Stenotic atherosclerosis of brachiocephalic arteries in the patient's history.
- Acute cerebrovascular accident or its consequences in the patient's history.
- The patient is pregnant or plans to become pregnant within the next 3 months.
- Atrial fibrillation, patent foramen ovale, anomalies of the interatrial septum, history of heart and coronary vessel surgeries.
- Signs of blood clotting disorders in the patient's history and screening, history of antiphospholipid syndrome.
- Use of anticoagulant drugs less than 5 days before the procedure.
- Uncontrolled bronchial asthma, severe chronic obstructive pulmonary disease in the patient's history.
- 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.
- History of liver insufficiency, elevated ALT and AST levels at screening.
- History of generalized pain syndrome, fibromyalgia.
- For women: use of combined oral contraceptives with a history of thrombosis of any localization.
- History of epilepsy, epileptic syndrome, seizure disorders, neurological conditions other than the primary condition (migraine).
- 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.
- Malignant neoplasms within 5 years before screening, or current or suspected oncological disease.
- 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.
- 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.
- 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.
- Employees of the medical institution conducting the study or the sponsor company, their family members, or subjects in dependent relationships.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kyrgyzstan1 site, 1 recruiting
- Recruiting
Vedanta University Clinic
Bishkek, Bishkek, 720054
Andrey E Petrov, Md, PhD, +996 707 207 428, doctorpetrovandrey@gmail.com
Andrey S Dakovskiy, MD, +972532786627, dakovskiyandrey@gmail.com
About this study
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
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
- Being tested
- liquid embolic agent SQUID 12, liquid embolic agent SQUID 18
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid embolic agent SQUID 12, liquid embolic agent SQUID 18Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic resistant migraine | Experimental | Not described Receives: Device: liquid embolic agent SQUID 12, liquid embolic agent SQUID 18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From previous 4 weeks before enrollment to the 3 months (12 weeks) post-surgery
Secondary outcomes (17)
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
Measured: 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
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From surgery up 12 months (48 weeks) post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start17 Oct 2024
- Primary completionApr 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vedanta University Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrey S Petrov, MD, PhD, Principal investigator, Vedanta Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848166
- Sponsor's protocol ID
- СHROME
- Acronym
- CHROME
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decision on IPD sharing is in progress