Phase 2 Migraine Trial, Recruiting NCT05734625 Sponsor: Mayo Clinic Condition: Migraine
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Phase 2 Migraine Trial, Recruiting

NCT05734625
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who experience episodic migraines at least 4 times a month but fewer than 15 times a month, with pain rated 5 out of 10 or higher
  • People who are willing to keep their migraine medications the same throughout the six months of the trial — not starting or stopping any
  • People whose headache history fits the medical definition of migraine, meaning headaches lasting between 4 and 72 hours that include at least 2 of these features: pain on one side of the head, throbbing or pulsating pain, moderate to severe pain, and pain that gets worse with or causes avoidance of everyday physical activity
  • People whose migraine history also includes at least one of the following: nausea and/or vomiting, sensitivity to light (feeling the need to be in a dark room), or sensitivity to sound (feeling the need to be in a quiet environment)

Who may not be able to join:

  • People whose headache pain also affects the cheek area, not just the scalp
  • Women who are currently pregnant or breastfeeding, or who could become pregnant during the medication phase of the trial and are unwilling to use an accepted form of contraception (accepted forms include hormonal methods such as pills, patches, injections, vaginal ring, or implants; barrier methods used with spermicide; an intrauterine device/IUD; total hysterectomy or tubal ligation; or abstinence)
  • People with a known allergy or medical reason to avoid certain local anaesthetic medications (such as bupivacaine, lidocaine, or similar) or corticosteroids (confirm with trial site)
  • People who have previously received peripheral nerve block injections
  • People who are currently taking blood-thinning (anticoagulant) medication
  • People currently receiving Botox injections to prevent migraines
  • People who started a new medication with known migraine-prevention effects within the past two months, or who plan to start one during the study
  • People currently using opioid (opiate) pain medications
  • People with a history of drug or alcohol misuse within the past two years
  • People with unstable medical or surgical conditions that could affect their ability to take part in the trial
  • People with a history of brain surgery, surgical holes in the skull, skull fractures, or open skull defects
  • People who have an implanted nerve stimulator or a brain/spinal shunt device
  • People with a strong fear of needles
  • People with an active skin or soft tissue infection at or near the areas where injections would be given
  • People who have been diagnosed with medication overuse headache, cervicogenic headache (headache originating from the neck), post-traumatic headache, or cluster headaches

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Stephen Merry, MD, MPH, Mayo Clinic

Phone: 507-422-6823

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
10 July 2023
Est. completion
1 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Elimination of acute headache

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov