Efficacy of Nerve Blocks for Episodic Migraine

Efficacy of Peripheral Nerve Blocks for Episodic Migraine Treatment and Prophylaxis

Efficacy of Nerve Blocks for Episodic Migraine (NCT05734625) is a Phase 2 interventional studying Episodic Migraine, sponsored by Mayo Clinic. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Episodic Migraine and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Episodic Migraine subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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) Exclusion Criteria: * 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 * History of craniotomies, burr holes, skull fractures and/or have open skull defects * Patients with implanted nerve stimulators or shunts * Phobia of needles * Active skin or soft tissue infection overlying injection sites * Diagnosis of medication overuse, cervicogenic, post-traumatic, or cluster headaches or history on pre-enrollment questionnaire of cluster headache symptoms.

Treatments Being Tested

DRUG

Bupivacaine HCl 0.5% Injectable Solution

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

DRUG

Methylprednisolone 40 MG Injection

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Mayo Clinic in Rochester

Rochester, Minnesota, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05734625), the sponsor (Mayo Clinic), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05734625 clinical trial studying?

Who can participate in NCT05734625?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05734625?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05734625. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05734625. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.