Phase 4 Migraine Trial, Recruiting NCT06473597 Sponsor: Antonios Likourezos Condition: Migraine
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Phase 4 Migraine Trial, Recruiting

NCT06473597
Recruiting Phase 4

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:

  • You are between 18 and 65 years old and were seen in the emergency department
  • You came in with a headache that started recently (acute headache)
  • Your pain level is at least 5 out of 10 on a pain scale
  • You are fully awake, alert, and know who you are, where you are, and what time it is
  • You are able to understand and agree to the consent process for joining the study
  • You are able to describe any side effects you might feel and rate your pain using a number scale

Who may not be able to join:

  • You have a known allergy to Rimegepant or Rizatriptan (the study medications)
  • You are pregnant or breastfeeding
  • Your vital signs (such as blood pressure or heart rate) are unstable
  • You are unable to give your consent to participate
  • Your headache is suspected to be caused by something other than migraine (for example, if you have a fever of 100.4°F or higher, neurological symptoms, or need emergency brain imaging) (confirm with trial site)
  • You have heart disease, including chest pain (angina), a history of heart attack, or a condition where your heart arteries go into spasm (including Prinzmetal's angina)
  • You have a history of stroke or mini-stroke (TIA)
  • You have problems with blood flow to your legs or arms (peripheral vascular disease)
  • You have reduced blood flow to your intestines (ischemic bowel disease)
  • You have high blood pressure that is not well controlled
  • You are currently using or have recently used certain other headache medications, including other triptans or ergotamine-type medications
  • You have a specific type of migraine called hemiplegic or basilar migraine
  • You are currently taking, or have stopped within the last 2 weeks, a type of antidepressant called an MAO-A inhibitor
  • You are already taking Rimegepant regularly to prevent migraines
  • You are experiencing severe nausea and vomiting
  • Your headache is so severe that it needs immediate emergency treatment
  • You have serious liver problems
  • You are currently taking any of the following medications:
    • Certain antidepressants, including MAO inhibitors (such as phenelzine, selegiline, or tranylcypromine), SSRIs (such as citalopram, escitalopram, or sertraline), duloxetine, fluoxetine, venlafaxine, or trazodone
    • Certain other migraine medications, including sumatriptan, zolmitriptan, eletriptan, frovatriptan, almotriptan, dihydroergotamine, or ergotamine
    • Certain muscle relaxants, including cyclobenzaprine
    • Certain pain medications, including tramadol
    • Certain antidepressants called tricyclics, including amitriptyline, nortriptyline, or protriptyline
    • Amphetamine-based medications such as Adderall or Dexedrine
    • Certain antifungal medications, including ketoconazole or itraconazole
    • Certain antibiotics, including clarithromycin or erythromycin
    • Certain antibiotics called rifamycins, such as rifampin or rifabutin
    • Certain seizure medications, including carbamazepine or phenytoin
    • Certain heart medications, including amiodarone, quinidine, ranolazine, or verapamil
    • Cabergoline (a medication used for various hormonal conditions)

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 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Sergey Motov, MD, Maimonides Medical Center

Phone: 718-283-6000

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 4
Sponsor
Antonios Likourezos
Registry
ClinicalTrials.gov
Start date
1 September 2024
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Pain Score at 60 minutes

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: 28 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