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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening enrollment to the end of study follow-up at 12 weeks

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.