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Refractory MigrainePhase 2LIGHT 2NCT07361549

Localized Injection of Lidocaine Via the Middle Meningeal Artery for Headache Treatment

A Phase 2 study testing Lidocaine (drug) and Saline in people with Refractory Migraine and Headache, run by Daniel A Tonetti, MD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to test whether injecting lidocaine into two blood vessels of the brain can help treat chronic headaches (migraines) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Refractory Migraine, Headache
What is being tested?
Lidocaine (drug) and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteUnited States
Study dates
9 Sep 2026to Jul 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Age 18 years or above
  • Diagnosis of chronic migraine
  • Referred for diagnostic cerebral angiography to screen for intracranial pathology
  • Written informed consent able to be obtained from subject

Who cannot join

  • Baseline HIT-6 score less than 50
  • Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study
  • 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
  • Concomitant intracranial pathology (eg, intracranial malignancy)
  • Known hypersensitivity and/or contraindication to lidocaine or local anesthetics of the amide type
  • 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)
Show all 13Show fewer
  • Known contraindications for angiography (eg, ESRD not requiring hemodialysis). Patients with contrast allergy with be premeditated with diphenhydramine and steroids.
  • Contraindication to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC)
  • Concurrent participation in another research protocol for investigation of an experimental therapy
  • Per DSA imaging, presence of a cerebrovascular pathology known to cause headache (eg, arteriovenous malformation, dural arteriovenous fistula)
  • Per DSA imaging, presence of anastomosis or anatomical variation (eg, branches of middle meningeal artery) that could lead to increased procedural risk
  • Per DSA imaging, lack of endovascular access to either middle meningeal artery, or origin of the middle meningeal artery other than from the external carotid artery
  • Known or suspected inability to adhere to study protocol or protocol requirements, as per discretion of the Investigator or treating provider

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel A Tonetti, MD contact

(855) 306-3876

tonetti-daniel@cooperhealth.edu

Manisha Koneru, MD contact

koneru-manisha@cooperhealth.edu

United States1 site, 1 recruiting

  • Cooper University Health Care

    Camden, New Jersey, 08103

    Recruiting

Other trials in United States

About this study

Official title: Localized Injection of Lidocaine Via the Middle Meningeal Artery for Headache Treatment: A Randomized, Double-Blinded, Parallel Phase 2 Clinical Trial

The goal of this clinical trial is to test whether injecting lidocaine into two blood vessels of the brain can help treat chronic headaches (migraines)

Being tested
Lidocaine (drug), Saline
Keywords
headache, migraine, lidocaine, middle meningeal artery
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 (drug)Drug

    Also called Xylocaine

    Intra-arterial lidocaine infusion into bilateral middle meningeal arteries

  • SalineDrug

    Also called Fluids

    Intra-arterial saline infusion into bilateral middle meningeal arteries

Study groups in NCT07361549
Study groupRoleWhat they receive
TreatmentExperimentalIntra-arterial lidocaine
Receives: Drug: Lidocaine (drug)
ShamSham comparatorIntra-arterial saline
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Headache Impact Test-6 Scores (1 Month)

    Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms

    Measured: From baseline to 1 month follow-up

Secondary outcomes (13)

  1. Change in Numeric Pain Scores

    Difference in Numeric Pain Scores (0-10), with larger decreases in scores correlating with improvement in symptoms

    Measured: From baseline to periprocedural

  2. Change in Migraine Disability Assessment Scores

    Difference in Migraine Disability Assessment Scores, with larger decreases in scores correlating with improvement in symptoms

    Measured: From baseline to 3 month follow-up

  3. Change in Headache Impact Test-6 Scores Over Time (2 Months)

    Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms

    Measured: From baseline to 2 month follow-up

  4. Change in Headache Impact Test-6 Scores Over Time (3 Months)

    Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms

    Measured: From baseline to 3 month follow-up

  5. Proportion with Substantial or Severe Headache Impact Test-6 Scores (1 Month)

    Proportion of patients with substantial (56-59) or severe (>= 60) Headache Impact Test-6 scores, with higher scores correlating with worser symptoms

    Measured: From baseline to 1 month follow-up

  6. Proportion with Substantial or Severe Headache Impact Test-6 Scores (2 Months)

    Proportion of patients with substantial (56-59) or severe (>= 60) Headache Impact Test-6 scores, with higher scores correlating with worser symptoms

    Measured: From baseline to 2 month follow-up

  7. Proportion with Substantial or Severe Headache Impact Test-6 Scores (3 Months)

    Proportion of patients with substantial (56-69) or severe (>= 60) Headache Impact Test-6 scores, with higher scores correlating with worser symptoms

    Measured: From baseline to 3 month follow-up

  8. Proportion with Low Patient Global Impression of Change Scores (Post-Treatment)

    Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms

    Measured: From baseline to periprocedural

  9. Proportion with Low Patient Global Impression of Change Scores (1 Month)

    Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms

    Measured: From baseline to 1 month follow-up

  10. Proportion with Low Patient Global Impression of Change Scores (2 Months)

    Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms

    Measured: From baseline to 2 month follow-up

  11. Proportion with Low Patient Global Impression of Change Scores (3 Months)

    Proportion of patients with Patient Global Impression of Change Scores that are low (1-3), with lower scores correlating with better perception of symptoms

    Measured: From baseline to 3 month follow-up

  12. Related or Serious Adverse Events

    Incidence of related adverse events or serious adverse events

    Measured: From post-treatment to 1 week

  13. New Stroke or All-Cause Death

    Incidence of new, disabling stroke or death from any cause

    Measured: From post-treatment to 1 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start9 Sep 2026
  3. Primary completionDec 2030 (estimated)
  4. Study completionJul 2031 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07361549
Sponsor's protocol ID
24-279
Acronym
LIGHT 2
Status last verified
Sep 2026
First submitted
21 Jan 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lidocaine (drug) and Saline in people with Refractory Migraine and Headache, run by Daniel A Tonetti, MD 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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel A Tonetti, MD ((855) 306-3876, tonetti-daniel@cooperhealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Headache Impact Test-6 Scores (1 Month) (time frame: From baseline to 1 month 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 NCT07361549, 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 1 Oct 2026.

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