Efficacy of Nerve Blocks for Episodic Migraine

NCT05734625 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 22-007151
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see how well blocking two to ten of the scalp nerves (that give feeling to the scalp and are painful during migraine headaches) with bupivacaine anesthetic (numbing medication) and low dose methylprednisolone (cortisone-like medicine or steroid) work for treating and preventing migraines. Our hypothesis is that the pain of most episodic migraine headaches can be eliminated and prevented for months by blocking the nerves that give pain sensation during a migraine.

Conditions

Episodic Migraine

Outcome Measures

Primary Outcomes (1)

• Elimination of acute headache

  Number of subjects to experience an elimination of acute headache defined as pain \</= 1/10

  20 minutes after the last nerve intended for block

Secondary Outcomes (2)

• Average headache days

  3 months after peripheral nerve block

• Days of work/school/life event absenteeism

  3 months after peripheral nerve block

Study Arms (2)

Greater Occipital Nerve block group

EXPERIMENTAL

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

Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Methylprednisolone 40 MG Injection

Multiple Peripheral Nerve block group

EXPERIMENTAL

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

Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Methylprednisolone 40 MG Injection

Interventions

Bupivacaine HCl 0.5% Injectable Solution DRUG

Will receive 0.5 ml (supratrochlear) to 1.0 ml (supraorbital, auriculotemporal) to 1.25 ml (greater and lesser occipital) for each nerve block.

Greater Occipital Nerve block group; Multiple Peripheral Nerve block group

Methylprednisolone 40 MG Injection DRUG

Will receive 10 mg (0.25 ml) mixed with 1.25 ml Bupivacaine 0.5% for each greater and lesser occipital nerve block if MPNB group or 20 mg (0.5 ml) methylprednisolone in each GON if GONB group.

Greater Occipital Nerve block group; Multiple Peripheral Nerve block group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Suffering from episodic migraines with and without aura occurring at least four times a month but less than 15 times a month at a severity of 5/10 pain level or greater.
• 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 at least 2 of the 4 following: unilateral location, pulsating/throbbing quality, moderate-severe intensity, aggravation by/causing avoidance of routine physical activity, and
• Have a history of at least one of the following: nausea and/or vomiting, photophobia (seek out a dark room during a headache because that feels better), phonophobia (seek out a quiet environment during a headache because that feels better)

You may not qualify if:

• Headache in cheeks (infraorbital nerve distribution) in addition to scalp distribution.
• Women who report being currently pregnant or lactating or are of child-bearing potential or are likely to become pregnant during the medication phase and are unwilling to use a reliable form of contraception. Acceptable forms include:
• Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
• Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
• Intrauterine device (IUD)
• Total hysterectomy or tubal ligation
• Abstinence (no sex)
• Allergy or documented contraindication to amide anesthetics (bupivacaine, lidocaine, ropivacaine, prilocaine, mepivacaine, etidocaine or levobupivacaine) or corticosteroids
• Previously received peripheral nerve blocks (PNBs)
• Currently anticoagulated
• Currently receiving Botox for migraine prophylaxis
• Started on new medication in the prior two months with known migraine-preventive efficacy or planning to start any new medication during the study
• Currently using opiate medications for pain
• History of drug or alcohol abuse within the prior two years
• Have unstable medical or surgical diseases that could impair participation in this study

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Bupivacaine; Methylprednisolone; Injections

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Stephen Merry, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Family Medicine Research Study Coordinators

CONTACT

507-422-6823; RSTFMSC@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Research subjects will be informed that they are in a trial of nerve blocks in treatment and prevention of migraine headache and may receive up to 10 nerve blocks. The language of consenting will seek to minimize bias by seeking to avoid suggesting that more blocks are better than less as follows: "There are small and large nerves all over the front, back and sides of your head that can contribute to a migraine headache. In this study, subjects will get nerve blocks in various combinations of one or two or up to 10 nerves at a time. The nerves blocked may or may not respond to the location of your pain."
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pragmatic randomized comparison trial

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: July 10, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)