Refractory MigrainePhase 1LIGHT 1NCT06462781
Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment Phase 1
A Phase 1 study testing Lidocaine hydrochloride and Methylprednisolone sodium succinate in people with Refractory Migraine, run by Cooper Norcross Health at 1 site in United States.
Trial summary
The goal of this clinical trial is to test whether injecting lidocaine and steroids into two blood vessels of the brain can help treat chronic headaches (migraines). The main questions this study aims to answer: is this treatment safe for chronic migraine patients? Participants will: Be treated once with lidocaine and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Migraine
- What is being tested?
- Lidocaine hydrochloride and Methylprednisolone sodium succinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to 1 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper University Health Care
Camden, New Jersey, 08103
About this study
Official title: Intra-Arterial Injection of Lidocaine and Glucocorticoid in the Treatment of Intractable Headaches: A Non-Randomized, Open-Label Phase 1 Clinical Trial
The goal of this clinical trial is to test whether injecting lidocaine and steroids into two blood vessels of the brain can help treat chronic headaches (migraines).
The main questions this study aims to answer: is this treatment safe for chronic migraine patients?
Participants will:
- Be treated once with lidocaine and steroid infused into the middle meningeal arteries (two blood vessels in the brain).
- Attend appointments scheduled 1 week, 6 weeks, and 12 weeks after the treatment for a checkup.
- Keep a log of their symptoms.
- Conditions
- Refractory Migraine
- Being tested
- Lidocaine hydrochloride, Methylprednisolone sodium succinate
- Keywords
- headache, migraine, lidocaine, glucocorticoid, middle meningeal artery, intra-arterial, status migrainosus
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine hydrochlorideDrug
Also called lidocaine, Xylocaine-MPF
Intra-arterial injection of 40mg lidocaine per middle meningeal artery (total 2 arteries) administered one time
Methylprednisolone sodium succinateDrug
Also called methylprednisolone, SOLU-MEDROL
Intra-arterial injection of 20mg methylprednisolone per middle meningeal artery (total 2 arteries) administered one time
| Study group | Role | What they receive |
|---|---|---|
| Treatment Cohort | Experimental | Intra-arterial 80mg lidocaine and 40mg methylprednisolone Receives: Drug: Lidocaine hydrochloride; Drug: Methylprednisolone sodium succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Reported adverse events classified using MedDRA and CTCAE, including all events, treatment-related events, and any serious adverse event
Measured: From treatment to 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start15 Mar 2024
- Primary completion13 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractory MigraineStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Vascular and Interventional Neurology
- Responsible party
- Principal investigator, Daniel A Tonetti, MD, Cooper Norcross Health
- Investigators
- Daniel A Tonetti, MD, Principal investigator, Cooper Norcross HealthManisha Koneru, MD, Study chair, Cooper Norcross HealthHamza A Shaikh, MD, Study chair, Cooper Norcross Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462781
- Sponsor's protocol ID
- 23-267
- Acronym
- LIGHT 1
- Status last verified
- Nov 2025
- First submitted
- 12 Jun 2024
- Last updated
- 4 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Koneru M, Shaikh HA, Khalife J, Syrow L, Santucci J, Ballout AA, Patel PD, Thomas AJ, Jovin TG, Tonetti DA. Localized Injection of Lidocaine and Glucocorticoid for Refractory Headache Treatment (LIGHT): A Phase 1 Clinical Trial for Safety. Stroke Vasc Interv Neurol. 2025 Oct 29;5(6):e001966. doi: 10.1161/SVIN.125.001966. eCollection 2025 Nov. No abstract available.
PubMed 41608705
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Arterial Injection of Lidocaine and Glucocorticoid in the Treatment of Intractable Headaches: A Non-Randomized, Open-Label Phase 1 Clinical Trial
- ClinicalTrials.gov ID
- NCT06462781
- Acronym / sponsor ID
- LIGHT 1 / 23-267
- Conditions
- Refractory Migraine
- Keywords
- headache, migraine, lidocaine, glucocorticoid, middle meningeal artery, intra-arterial, status migrainosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Collaborators
- Society of Vascular and Interventional Neurology
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test whether injecting lidocaine and steroids into two blood vessels of the brain can help treat chronic headaches (migraines).
The main questions this study aims to answer: is this treatment safe for chronic migraine patients?
Participants will:
- Be treated once with lidocaine and steroid infused into the middle meningeal arteries (two blood vessels in the brain).
- Attend appointments scheduled 1 week, 6 weeks, and 12 weeks after the treatment for a checkup.
- Keep a log of their symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Cohort | Experimental | Drug: Lidocaine hydrochloride, Drug: Methylprednisolone sodium succinateIntra-arterial 80mg lidocaine and 40mg methylprednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine hydrochlorideAlso: lidocaine, Xylocaine-MPFIntra-arterial injection of 40mg lidocaine per middle meningeal artery (total 2 arteries) administered one time | Drug | Treatment Cohort |
| Methylprednisolone sodium succinateAlso: methylprednisolone, SOLU-MEDROLIntra-arterial injection of 20mg methylprednisolone per middle meningeal artery (total 2 arteries) administered one time | Drug | Treatment Cohort |
Primary outcome
Number of Adverse Events
Time frame: From treatment to 12-week follow-up
Reported adverse events classified using MedDRA and CTCAE, including all events, treatment-related events, and any serious adverse event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Results publication: PubMed 41608705Koneru M, Shaikh HA, Khalife J, Syrow L, Santucci J, Ballout AA, Patel PD, Thomas AJ, Jovin TG, Tonetti DA. Localized Injection of Lidocaine and Glucocorticoid for Refractory Headache Treatment (LIGHT): A Phase 1 Clinical Trial for Safety. Stroke Vasc Interv Neurol. 2025 Oct 29;5(6):e001966. doi: 10.1161/SVIN.125.001966. eCollection 2025 Nov. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel A Tonetti, MD principal investigator
Cooper Norcross Health
Manisha Koneru, MD study chair
Cooper Norcross Health
Hamza A Shaikh, MD study chair
Cooper Norcross Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lidocaine hydrochloride and Methylprednisolone sodium succinate in people with Refractory Migraine, run by Cooper Norcross Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: From treatment to 12-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06462781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.