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New treatment option for Migraine
Official title A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache
ClinicalTrials.gov ID: NCT06473597
What this study is testing
What is Rimegepant?
Rimegepant is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for migraine.
Also referred to as Nurtec ODT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- 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...
- Ischemic coronary artery disease (angina pectoris, history of myocardial infarction), coronary artery vasospasm (including Prinzmetal's angina)
See the full eligibility 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Brooklyn, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brooklyn, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.