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NCT06985342 · ClinicalTrials.gov registry record · Phase 4
Acute Migraine Treatment in the ED With Gepants
A Phase 4 study of Migraine Headaches, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06985342: Recruiting Phase 4 study of Migraine Headaches, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06985342 is a Phase 4 study of Migraine Headaches that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 100 participants, below the 111-participant average among 4 other Migraine Headaches trials with a reported enrollment target (10% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06985342, a Phase 4 study of Migraine Headaches, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluates the effectiveness of rimegepant 75 mg orally disintegrating tablet (ODT) single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments during Emergency Department (ED) encounters. Although these two calcitonin gene-related peptide receptors (CGRP) receptor antagonists are FDA-approved for the indication of acute migraine treatment, past studies have been limited to the outpatient setting. If these medications are effective in the Emergency Department, their delivery methods alone may have advantages over intravenous medications commonly used for acute migraine in EDs, including quicker time to treatment delivery, faster pain relief, and reduced ED length of stay. This investigation is a pilot study to examine rimegepant and zavegepant in an ED, to gain insight on effectiveness in this setting. This study will administer rimegepant 75 mg ODT single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments to 100 patients in the Emergency Department. It is a single center, open-label, non-controlled 2-group clinical trial (allocated 1:1 to rimegepant or zavegepant via pseudo-random assignment). The study will enroll adults in the ED meeting ICHD-3 criteria for migraine or probable migraine, with or without aura.
Primary Outcome
Percentage of participants reporting pain as 'mild' or 'none' at 2 hours post-study drug administration, without rescue medication. Pain is categorized as none, mild, moderate, or severe.
Conditions Studied
Interventions
- DRUG Rimegepant
- DRUG Zavegepant
Study Locations (1)
New York
- Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-06-05 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 4 |
What NCT06985342 shows while recruiting
NCT06985342 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 111-participant average among 4 other Migraine Headaches trials with a reported enrollment target (10% lower).
The record links to 1 condition, with Migraine Headaches appearing as the primary indexed condition, and to 2 interventions - of which Rimegepant is the first listed.
NCT06985342 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06985342 about?
NCT06985342 is a clinical study titled "Acute Migraine Treatment in the ED With Gepants". This study evaluates the effectiveness of rimegepant 75 mg orally disintegrating tablet (ODT) single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments during Emergency Department (ED) encounters. Although these two calcitonin gene-related peptide receptors (CGRP) receptor...
What is the current status of trial NCT06985342?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2025-06-05. Estimated completion is 2026-10-30.
What conditions does trial NCT06985342 study?
This clinical trial studies the following conditions: Migraine Headaches.
What interventions are being tested in trial NCT06985342?
The interventions under investigation include: Rimegepant (DRUG), Zavegepant (DRUG).
Who is sponsoring clinical trial NCT06985342?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06985342 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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