Actively Recruiting
Comparison of Rimegepant Orally Disintegrating Tablet and Rizatriptan Benzoate Orally Disintegrating Tablet in Adults with Migraine Headache in the Emergency Department
Led by Antonios Likourezos · Updated on 2025-10-01
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating and comparing the pain relief effects and safety of two oral migraine treatments, Rimegepant (Nurtec ODT) and Rizatriptan (Maxalt MLT-ODT), in adults experiencing acute migraine headaches. This randomized, double-blind trial is conducted in an urban emergency department setting with adult patients diagnosed with migraine without aura, seeking to determine which medication provides better pain relief within 60 and 120 minutes. Participants receive either Rimegepant 75 mg or Rizatriptan 10 mg orally disintegrating tablets during their emergency department visit. The study involves careful monitoring of headache intensity every 30 minutes for up to 120 minutes after medication. Patients who need additional pain relief after one hour may receive rescue medication as determined by their physician. The trial includes follow-up by phone 24 hours after discharge to assess headache status and treatment satisfaction. During the study, participants will rate their pain using a validated 11-point numerical scale and describe their headache severity and functional ability using standard categorical scales. Researchers will record demographic, medical, and vital sign data, and evaluate outcomes such as pain reduction at 60 minutes, use of rescue medication, sustained headache relief for 24 hours, and patient satisfaction with treatment. The total involvement includes the emergency visit and a phone follow-up 24 hours later.
CONDITIONS
Brief Title
A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult emergency department patients aged 18 to 65 years
- Presenting with an acute headache
- Initial pain score of 5 or higher on an 11-point numeric rating scale
- Awake, alert, and oriented to person, place, and time
- Able to understand and provide informed consent
- Able to describe pain severity and any adverse effects verbally
You will not qualify if you...
- Allergy to Rimegepant or Rizatriptan
- Pregnant or breastfeeding
- Unstable vital signs
- Unable to provide informed consent
- Suspected non-migraine causes of headache requiring urgent brain imaging
- Fever 100.4°F or higher
- Objective neurological findings
- History of ischemic coronary artery disease or coronary artery vasospasm
- History of stroke or transient ischemic attack
- Peripheral vascular disease
- Ischemic bowel disease
- Uncontrolled high blood pressure
- Use of certain medications including other 5-HT1 agonists, ergotamine-containing drugs, MAO-A inhibitors within 2 weeks, and several listed contraindicated drugs
- Hemiplegic or basilar migraine
- Severe nausea, vomiting, or headache requiring immediate intervention
- Severe liver impairment
- Current preventive use of Rimegepant as prophylaxis therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit (in-person in the emergency department)
Duration - Up to 2 hours
Participants receive a single dose of either Rimegepant or Rizatriptan orally disintegrating tablets for acute migraine headache in the emergency department.
Continuous monitoring in the emergency department for up to 2 hours after medication administration with headache level assessed every 30 minutes
Duration - 1 day
Participants are contacted by telephone 24 hours after emergency department discharge to assess headache status, treatment satisfaction, and any adverse events.
1 phone call follow-up
Trial Site Locations
Total: 1 location
1
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Actively Recruiting
Research Team
S
Sergey Motov, MD
A
Antonios Likourezos, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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