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

ConditionsRefractory Migraine Headache

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorDaniel A Tonetti, MD

About this 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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or above

Referred for diagnostic angiography

Diagnosis of intractable migraine

Written informed consent able to be obtained from subject

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Lidocaine (drug)
Drug
Intra-arterial lidocaine infusion into bilateral middle meningeal arteries
Saline
Drug
Intra-arterial saline infusion into bilateral middle meningeal arteries

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: TreatmentExperimental treatment 1 intervention

Group B: ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Headache Impact Test-6 Scores

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

Time frame

From baseline to 4 week follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daniel A Tonetti, MD

Lead sponsor

The Cooper Health System

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: