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Corticosteroid

Nerve Blocks for Migraines

Phase 2

Recruiting

Led By Stephen Merry, MD, MPH

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to not start or stop any new medication to treat or prevent migraines during the six months of the trial

History fits the definition of migraine: Have a history of episodic headache lasting 4-72 hours with specific characteristics and associated symptoms

Must not have

Allergy or documented contraindication to specific anesthetics or corticosteroids

Various medical or surgical exclusions including unstable diseases, history of specific head surgeries, implanted nerve stimulators or shunts, and active skin or soft tissue infection overlying injection sites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 minutes after the last nerve intended for block

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how blocking certain nerves and using numbing meds and steroids can help treat and prevent migraines.

Who is the study for?

This trial is for individuals who experience episodic migraines at least four times a month but less than fifteen, with pain levels of 5/10 or higher. Participants should not start or stop any migraine medications during the six-month study and must fit the specific criteria for migraine headaches. Pregnant women, those allergic to anesthetics or steroids, on certain medications like blood thinners, Botox for migraines, opiates, or have a history of substance abuse are excluded.

What is being tested?

The study tests if nerve blocks using bupivacaine (a numbing agent) and low-dose methylprednisolone (a steroid) can treat and prevent episodic migraines by targeting scalp nerves linked to migraine pain. The hypothesis suggests that this treatment could relieve pain and prevent future episodes for months.

What are the potential side effects?

Possible side effects may include reactions at the injection site such as pain or infection, allergic reactions to the drugs used in the nerve block procedure, systemic effects from steroids like mood changes or increased blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree not to change my migraine medications for six months.

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I have a history of migraines lasting 4-72 hours with specific symptoms.

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I experience migraines 4-14 times a month with severe pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic or cannot take certain anesthetics or corticosteroids.

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I don't have unstable diseases, recent major head surgeries, nerve stimulators, shunts, or infections at injection sites.

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I have been diagnosed with a specific type of headache.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 minutes after the last nerve intended for block

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 minutes after the last nerve intended for block

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minutes after the last nerve intended for block for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Elimination of acute headache

Secondary study objectives

Average headache days

Days of work/school/life event absenteeism

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Multiple Peripheral Nerve block groupExperimental Treatment2 Interventions

Subjects will receive 10 nerve blocks to include bilateral greater occipital, lesser occipital, auriculotemporal, supraorbital and supratrochlear nerves.

Group II: Greater Occipital Nerve block groupExperimental Treatment2 Interventions

Subjects will receive bilateral greater occipital nerve blocks for a total of 2 blocks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine HCl 0.5% Injectable Solution

2021

Completed Phase 4

~90

0 / 6Eligibility criteria met