Localized Injection of Lidocaine Via the Middle Meningeal... | NCT07361549

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

NCT07361549

Sponsor

Daniel A Tonetti, MD

Status

Not yet recruiting

Last Update Posted

Jan 23, 2026Actual

Enrollment

80Estimated

Phase

Phase 2

Conditions

Refractory Migraine
Headache

Interventions

Lidocaine (drug)
Saline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2026Estimated

Primary Completion Date

Dec 2030Estimated

Completion Date

Jul 2031Estimated

First Submitted Date

Jan 21, 2026

First Submission Date that Met QC Criteria

Jan 21, 2026

First Posted Date

Jan 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2026

Last Update Posted Date

Jan 23, 2026Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Intra-arterial lidocaine	Drug: Lidocaine (drug)
Sham	Sham Comparator	Intra-arterial saline	Drug: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine (drug)	Drug	Intra-arterial lidocaine infusion into bilateral middle meningeal arteries	Treatment

Measure	Description	Time Frame
Change in Headache Impact Test-6 Scores	Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms	From baseline to 4 week follow-up

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or above
Referred for diagnostic angiography
Diagnosis of intractable migraine
Written informed consent able to be obtained from subject

Exclusion Criteria:

Baseline HIT-6 score less than 60 (severe)
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)
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008881	Migraine Disorders
D006261	Headache

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D008012	Lidocaine
D004364	Pharmaceutical Preparations
D012965	Sodium Chloride
D005440	Fluid Therapy

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814