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Combination Drug

AXS-07 for Migraine

Phase 3
Recruiting
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hour 2 following dose administration
Awards & highlights

Study Summary

This trial is testing a new drug for migraines in people who haven't responded well to other drugs. They want to see if it's effective and safe.

Who is the study for?
This trial is for adults who have migraines, with or without aura, and haven't had success treating them with oral CGRP inhibitors. Participants should not be pregnant, breastfeeding, nor planning to become pregnant during the study. They also shouldn't have used any investigational drugs or therapies within 30 days before screening.Check my eligibility
What is being tested?
The trial is testing AXS-07 (a combination of meloxicam-rizatriptan) for its effectiveness in relieving migraine symptoms in those who didn't respond well to previous treatments with oral CGRP inhibitors. It's an open-label study where everyone knows they're getting this specific medication.See study design
What are the potential side effects?
Possible side effects of AXS-07 may include typical reactions associated with pain relief medications like meloxicam (such as stomach upset or ulcers) and rizatriptan (like dizziness, fatigue, dry mouth). However, individual responses can vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hour 2 following dose administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and hour 2 following dose administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of subjects with absence of the Most Bothersome Symptom
Headache

Trial Design

1Treatment groups
Experimental Treatment
Group I: AXS-07 (meloxicam-rizatriptan)Experimental Treatment1 Intervention
Up to 8 weeks

Find a Location

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
28 Previous Clinical Trials
8,092 Total Patients Enrolled
3 Trials studying Migraine
2,602 Patients Enrolled for Migraine

Media Library

AXS-07 (Combination Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05550207 — Phase 3
Migraine Research Study Groups: AXS-07 (meloxicam-rizatriptan)
Migraine Clinical Trial 2023: AXS-07 Highlights & Side Effects. Trial Name: NCT05550207 — Phase 3
AXS-07 (Combination Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05550207 — Phase 3
Migraine Patient Testimony for trial: Trial Name: NCT05550207 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has AXS-07 (meloxicam-rizatriptan) been cleared by the FDA?

"AXS-07 (meloxicam-rizatriptan) is a Phase 3 trial drug, meaning that there is both evidence of its efficacy and safety. Consequently, our team has rated it a 3 in terms of safety."

Answered by AI

Can you list all of the places where this trial is being conducted?

"This trial is running at 19 sites, which are located in Knoxville, Stamford, Williamsville and 19 other locations. To minimize travel demands, it is helpful to select the location nearest you."

Answered by AI

Who else is applying?

What state do they live in?
Texas
North Carolina
Florida
Other
What site did they apply to?
Clinical Research Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
0
3+

Why did patients apply to this trial?

Migraines are getting worse. The trip tans have never worked for me. Trying to get Help to feel better with myself.
PatientReceived 2+ prior treatments
Imitrex, Rezitriptan, Nurtec, tried samples of qulipta. because I can help other people and I also need the cash.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Yes, how long does it last? How much does it pay and do you pay with a prepaid debit that you can use at an ATM? How many visits would I have to do? Would I get paid for each time I come in?
PatientReceived 2+ prior treatments
How long is the commitment, what is the expected result of the drug, what is the compensation, frequency of visits, name of drug, delivery and dosages, number of doses, schedule and time of appointments during the day and week?
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Clinical Research Site: < 24 hours
Typically responds via
Email
Phone Call
Recent research and studies
clinicaltrials.govStudy
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)
2022. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05550207.
All > Migraine Headaches > Migraine
~26 spots leftby Dec 2024
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