NCT06473597 A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache
| NCT ID | NCT06473597 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Antonios Likourezos |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-12-31 |
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.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2024-09-01 with a primary completion date of 2026-12-31.
⚠ 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
Rimegepant (Nurtec) is an orally administered small molecule CGRP receptor antagonist with efficacy in the acute treatment of migraine. Rizatriptan benzoate (MAXALT), is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan binds with high affinity to human cloned 5-HT1B and 5-HT1D receptors which leads to activation of these receptors results in cranial vessel constriction, inhibition of neuropeptide release and reduced transmission in trigeminal pain pathways with resultant relieve of the headache. Teh investigators hypothesize that the administration of Rimegepant ODT would provide better analgesic efficacy than Rizatriptan ODT with respect to analgesic efficacy at 60 min and 120 minutes in ED patients with acute headache. This is a prospective, randomized, double-blind superiority trial evaluating and comparing analgesic efficacy and safety of Rimegepant ODT 75 mg to Rizatriptan ODT 10 mg in adult patients presenting to the Emergency Department of Maimonides Medical Center with acute migraine headache.
Eligibility Criteria
Inclusion Criteria: * Adult ED patients age 18 to 65 years old * Acute headache * Initial Pain score of 5 on a standard 11- point (score 0 to 10) numeric rating scale * Patients will have to be awake, alert, and oriented to person, place, and time * Patients able to demonstrate understanding of the informed consent process and content. * Patients also will have to demonstrate ability to verbalize the nature of any adverse effects they might experience as well as to express their pain severity by using the NRS. Exclusion Criteria: * Allergy to Rimegepant or Rizatriptan * Pregnancy and breastfeeding * Unstable vital signs * Inability to provide consent * Suspicion for disease process other than migraine (those requiring emergent brain imaging, with a temperature of 100.4 °F, with objective neurologic findings, secondary headache (an "organic" headache)) * Ischemic coronary artery disease (angina pectoris, history of myocardial infarction), coronary artery vasospasm (including Prinzmetal's angina) * History of stroke or transient ischemic attack * Peripheral vascular disease * Ischemic bowel disease, * Uncontrolled hypertension * Use of another 5-HT1 agonist, ergotamine-containing medications, or ergot-type medications (methylsergide) * Hemiplegic or basilar migraine * Concurrent administration or recent discontinuation (within 2 weeks) of a MAO-A inhibitors * Current use of Rimegepant as a prophylactic * Severe Nausea and Vomiting * Severe headache requiring immediate intervention * Severe hepatic impairment * If taking any of the following medications (contraindications): * Monoaminoxidaze (MAO) inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) * SSRI- Citalopram, Escitalopram, Sertraline * Triptans: Sumatriptan, Zolmitriptan, Imigran * Almotriptan. * Cabergoline. * Dihydroergotamine. * Dihydroergotamine intranasal * Eletriptan * Ergoloid mesylates * Ergotamine * Frovatriptan * Duloxetine * Cyclobenzaprine * Fluoxetine, velafaxine * Trazodone * Tramadol * TCA: nortriptyline (Pamelor), amitriptyline, protriptyline * Amphetamines: methamphetamine (Desoxyn), dextroamphetamine (Adderall, Adderall XR), dextroamphetamine (Dexedrine) * azole antifungals ( ketoconazole, itraconazole) * macrolide antibiotics (clarithromycin, erythromycin) * rifamycins (such as rifampin, rifabutin) * carbamazepine, phenytoin * Cardiac Drug: amiodarone (Nexterone, Pacerone), quinidine, ranolazine (Aspruzyo Sprinkle), verapamil (Verelan, Verelan PM)
Contact & Investigator
Sergey Motov, MD
PRINCIPAL INVESTIGATOR
Maimonides Medical Center
Frequently Asked Questions
Who can join the NCT06473597 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying 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 NCT06473597 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06473597 currently recruiting?
Yes, NCT06473597 is actively recruiting participants. Contact the research team at smotov@maimo.org for enrollment information.
Where is the NCT06473597 trial being conducted?
This trial is being conducted at Brooklyn, United States.
Who is sponsoring the NCT06473597 clinical trial?
NCT06473597 is sponsored by Antonios Likourezos. The principal investigator is Sergey Motov, MD at Maimonides Medical Center. The trial plans to enroll 80 participants.
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