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COMPLETED Phase 3

Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)

NCT05550207 · View on ClinicalTrials.gov ↗

Study Summary

This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.

Conditions Studied

Interventions

  • DRUG AXS-07 (meloxicam-rizatriptan)

Study Locations (20)

Florida

  • Clinical Research Site — DeLand
  • Clinical Research Site — Hallandale
  • Clinical Research Site — Hollywood
  • Clinical Research Site — Miami
  • Clinical Research Site — Ormond Beach
  • Clinical Research Site — Oviedo
  • Clinical Research Site — Pensacola
  • Clinical Research Site — Winter Park

California

  • Clinical Research Site — Colton
  • Clinical Research Site — Fullerton
  • Clinical Research Site — La Jolla
  • Clinical Research Site — Los Angeles
  • Clinical Research Site — Sherman Oaks

Massachusetts

  • Clinical Research Site — Boston
  • Clinical Research Site — North Dartmouth

Connecticut

  • Clinical Research Site — Stamford

Georgia

  • Clinical Research Site — Stockbridge

Indiana

  • Clinical Research Site — Avon

Nevada

  • Clinical Research Site — Las Vegas

New Mexico

  • Clinical Research Site — Albuquerque

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2022-08-31
Est. Completion 2024-11-27
Phase Phase 3

Sponsor

Axsome Therapeutics

11 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05550207

The ClinicalTrials.gov registry entry for NCT05550207 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Axsome Therapeutics, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 1 intervention — of which AXS-07 (meloxicam-rizatriptan) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05550207 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05550207 about?

NCT05550207 is a clinical study titled "Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)". This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.

What is the current status of trial NCT05550207?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2022-08-31. Estimated completion is 2024-11-27.

What conditions does trial NCT05550207 study?

This clinical trial studies the following conditions: Migraine. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05550207?

The interventions under investigation include: AXS-07 (meloxicam-rizatriptan) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05550207?

This trial is sponsored by Axsome Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05550207 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial