A Phase 2 interventional study of Lidocaine (drug) and Saline in Refractory Migraine and Headache, sponsored by Daniel A Tonetti, MD. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Daniel A Tonetti, MD · Phase 2, Interventional, and Treatment
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)
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →This is the only study on the registry with Daniel A Tonetti, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intra-arterial lidocaine
Drug: Lidocaine (drug)
Intra-arterial saline
Drug: Saline
Intra-arterial lidocaine infusion into bilateral middle meningeal arteries
Also known as: Xylocaine
Intra-arterial saline infusion into bilateral middle meningeal arteries
Also known as: Fluids
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
Time frame: From baseline to 1 month follow-up
Change in Numeric Pain Scores
Difference in Numeric Pain Scores (0-10), with larger decreases in scores correlating with improvement in symptoms
Time frame: From baseline to periprocedural
Change in Migraine Disability Assessment Scores
Difference in Migraine Disability Assessment Scores, with larger decreases in scores correlating with improvement in symptoms
Time frame: From baseline to 3 month follow-up
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
Time frame: From baseline to 2 month follow-up
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
Time frame: From baseline to 3 month follow-up
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
Time frame: From baseline to 1 month follow-up
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
Time frame: From baseline to 2 month follow-up
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
Time frame: From baseline to 3 month follow-up
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
Time frame: From baseline to periprocedural
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
Time frame: From baseline to 1 month follow-up
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
Time frame: From baseline to 2 month follow-up
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
Time frame: From baseline to 3 month follow-up
Related or Serious Adverse Events
Incidence of related adverse events or serious adverse events
Time frame: From post-treatment to 1 week
New Stroke or All-Cause Death
Incidence of new, disabling stroke or death from any cause
Time frame: From post-treatment to 1 month follow-up
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Lidocaine