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Lidocaine + Steroid Injections for Migraines (LIGHT Trial)

Phase 2
Waitlist Available
Led By Daniel A Tonetti, MD, MS
Research Sponsored by The Cooper Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female greater than or equal to 18 years of age
Be older than 18 years old
Must not have
Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study. Medically acceptable contraceptives include: surgical sterilization (such as tubal ligation or hysterectomy), approved hormonal contraceptives (such as birth control pills, patches, implants, or injections), barrier methods (such as condom or diaphragm) used with a spermicide, or an intrauterine device (IUD)
Patients with concomitant intracranial pathology (e.g., intracranial malignancy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening enrollment to the end of study follow-up at 12 weeks
Awards & highlights

Summary

This trial aims to investigate if injecting lidocaine and steroids into two blood vessels in the brain can help treat chronic migraines. The study will assess the safety and effectiveness of this treatment for chronic migraine

Who is the study for?
This trial is for individuals with chronic headaches or migraines. Participants will receive a one-time treatment involving injections of lidocaine and steroids into brain blood vessels and must attend follow-up appointments at specified intervals while keeping a symptom log.
What is being tested?
The study tests the safety and effectiveness of injecting lidocaine, a numbing medication, combined with methylprednisolone, an anti-inflammatory steroid, directly into the middle meningeal arteries compared to standard headache care.
What are the potential side effects?
Potential side effects may include discomfort at injection site, allergic reactions to medications used, increased risk of infection due to steroid use, and possible short-term changes in blood pressure or heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, and agree to use birth control during the study.
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I do not have any brain tumors or serious brain conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening enrollment to the end of study follow-up at 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening enrollment to the end of study follow-up at 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate and Duration of Symptomatic Relief
Secondary outcome measures
Number of Participants with Adverse Events

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment CohortExperimental Treatment2 Interventions
Intra-arterial 80mg lidocaine and 40mg methylprednisolone
Group II: Observational CohortActive Control1 Intervention
Continuation of standard therapies
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine hydrochloride
2015
Completed Phase 4
~300

Find a Location

Who is running the clinical trial?

The Cooper Health SystemLead Sponsor
79 Previous Clinical Trials
35,163 Total Patients Enrolled
1 Trials studying Migraine
50 Patients Enrolled for Migraine
Daniel A Tonetti, MD, MSPrincipal InvestigatorThe Cooper Health System
~153 spots leftby Mar 2027
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