Brain artery injection shows promise for tough migraines
NCT ID NCT06462781
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested whether injecting lidocaine and steroids into two brain arteries could safely treat chronic migraines that don't respond to standard treatments. Ten adults with hard-to-treat migraines received one injection and were followed for 12 weeks. The main goal was to check for side effects and see if the approach is safe enough for further study.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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10 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female greater than or equal to 18 years of age. * Documentation of a diagnosis of intractable migraine without aura, including failure of at least four classes of preventative drugs. Either intolerance or side effects requiring discontinuation or adequate trial at therapeutic dose without relief constitutes failure of therapy. * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study. Medically acceptable contraceptives include: (1) surgical sterilization (such as tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants, or injections), (3) barrier methods (such as condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. * Patients with concomitant intracranial pathology (e.g., intracranial malignancy). * Blood glucose level on screening complete metabolic blood panel \> 400 mg/dL. * Patients with known hypersensitivity and/or contraindication to either lidocaine hydrochloride or methylprednisolone sodium succinate, including: * Patients with known history of hypersensitivity to local anesthetics of the amide type. * Patients with systemic fungal infections. * Patients with known or suspected hypersensitivity to cow's milk or its components or other dairy products (SOLU-MEDROL® 40mg presentation includes lactose monohydrate, and may contain trace amounts of milk ingredients). * Patients taking chronic medications that, when co-administered with lidocaine and other local anesthetics, are at increased risk of developing methemoglobinemia: nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, acetaminophen, metoclopramide, quinine, sulfasalazine. * Patients taking chronic medications that, when co-administered with methylprednisolone, are at increased risk for hypokalemia, altered drug levels, convulsions, or altered clearance: amphotericin B, diuretics, aminoglutethimide, macrolide antibiotics, anticholinesterases, antitubercular drugs, cholestyramine, cyclosporine, digitalis glycosides, estrogens (including oral contraceptives), hepatic enzyme inducers/inhibitors, and ketoconazole. * Patients have known contraindications for angiography. Patients with contrast allergy will be premedicated with diphenhydramine and steroids. * Patient has known active systemic infection or sepsis. * Patient has contraindication to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC). * Concurrent participation in another research protocol for investigation of an experimental therapy. * Known or suspected inability to adhere to study protocol or protocol requirements, as per the discretion of the Investigator or treating provider.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cooper University Health Care
Camden, New Jersey, 08103, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.