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Tests treatment safety and results for Chronic Migraine Headache
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
ClinicalTrials.gov ID: NCT06848166
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 59
You may be able to join 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) /...
- Resistant nature of the migraine, determined by the doctor using the criteria of the European Headache Federation (EHF, 2020), established at least 6...
- 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...
You likely can't join if
- The patient has contraindications to undergoing embolization of the middle meningeal artery based on the medical history, results of examinations...
- 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...
- 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...
- A history of hyperthyroidism or diabetes. The presence of other endocrine disorders in the patient's history that, in the doctor's opinion, could...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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 how...
- 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...
- 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...
- 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...
- 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...
- Participation in other treatment 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...
- 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...
- Employees of the medical institution conducting the study or the sponsor company, their family members, or people in dependent relationships.
The study team makes the final eligibility decision.
Where it's taking place
- Bishkek, Bishkek, Kyrgyzstan
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 59 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bishkek, Bishkek, Kyrgyzstan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.