NCT05734625 Efficacy of Nerve Blocks for Episodic Migraine
| NCT ID | NCT05734625 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Episodic Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-07-10 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-07-10 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT05734625 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Episodic Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05734625 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05734625 currently recruiting?
Yes, NCT05734625 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mayo Clinic to inquire about joining.
Where is the NCT05734625 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05734625 clinical trial?
NCT05734625 is sponsored by Mayo Clinic. The trial plans to enroll 60 participants.
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