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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes after the last nerve intended for block
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Elimination of acute headache
Secondary outcome measures
Average headache days
Days of work/school/life event absenteeism

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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,428 Total Patients Enrolled
10 Trials studying Migraine
81,806 Patients Enrolled for Migraine
Stephen Merry, MD, MPHPrincipal InvestigatorMayo Clinic

Media Library

Methylprednisolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05734625 — Phase 2
Migraine Research Study Groups: Greater Occipital Nerve block group, Multiple Peripheral Nerve block group
Migraine Clinical Trial 2023: Methylprednisolone Highlights & Side Effects. Trial Name: NCT05734625 — Phase 2
Methylprednisolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05734625 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in the trial restricted to people who are 70 years old or younger?

"This clinical experiment has as a requirement for participation that applicants are between the ages of 18 and 64. Additionally, there exist 33 trials aimed at underage individuals and 111 trials tailored towards those aged 65 or older."

Answered by AI

Have the FDA sanctioned Greater occipital nerve block treatments?

"The safety of Greater occipital nerve block group is estimated to be a score 2, as the clinical trial data gathered thus far has only been able to demonstrate potential safety but not efficacy."

Answered by AI

Are there any enrollments being accepted for this research endeavor?

"According to information on the clinicaltrials.gov website, this trial is not presently enrolling participants. The study was first published on February 1st 2023 and underwent its last update on Feb 9th of that same year. Although no longer recruiting at present, there are currently 164 other trials actively seeking patients for similar treatments."

Answered by AI

Could I qualify to partake in this clinical investigation?

"This clinical trial seeks 60 adults aged 18-64 with recurrent migraine aura. The prerequisites for enrolment in this study include: having 4 to 15 migraines per month of at least 5/10 pain level, abstaining from any new medications while partaking in the 6 month experiment, suffering unilateral throbbing headaches lasting between 4 and 72 hours accompanied by nausea & vomiting or light/sound sensitivity."

Answered by AI

Who else is applying?

What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy of Nerve Blocks for Episodic Migraine
Stephen P. Merry 2023. "Efficacy of Nerve Blocks for Episodic Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05734625.
All > Migraine Headaches > Migraine
~30 spots leftby Feb 2025
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