What side effects are associated with this type of intervention?

Common treatments for migraines include CGRP inhibitors, triptans, and ergotamines. CGRP inhibitors can cause side effects such as injection site reactions, constipation, and potential cardiovascular issues. Triptans, like sumatriptan, may lead to side effects including dizziness, chest tightness, and potential cardiac side effects. Ergotamines can cause nausea, vomiting, and are associated with risks of cerebrovascular and cardiovascular complications, especially in patients with pre-existing conditions. Non-pharmacologic treatments like acupuncture generally have fewer adverse effects but may not be significantly more effective than sham treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine, including monoclonal antibodies targeting the CGRP pathway, such as eptinezumab, which is administered via IV infusion, and oral CGRP receptor antagonists like rimegepant and atogepant. These treatments have shown efficacy in reducing migraine frequency and severity, offering new options for patients who may not respond to traditional therapies.

What other types of research exist?

Promising novel alternatives to AXS-07 for migraine treatment in 2024 include: 1) CGRP monoclonal antibodies such as eptinezumab, erenumab, galcanezumab, and fremanezumab, which target the calcitonin gene-related peptide pathway for migraine prevention. 2) CGRP receptor antagonists, which provide a new therapeutic option by blocking the CGRP receptors involved in migraine pathophysiology. 3) Lasmiditan, a serotonin (5-HT1F) receptor agonist, approved for acute migraine treatment. These alternatives have demonstrated efficacy and safety in clinical trials and represent significant advancements in migraine therapy.

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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

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new migraine medication called AXS-07. It aims to help people whose migraines don't improve with common treatments. The study will see if AXS-07 can provide relief by working in a different way.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ hour 2 following dose administration

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of subjects with absence of the Most Bothersome Symptom

Headache

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AXS-07 (meloxicam-rizatriptan)Experimental Treatment1 Intervention

Up to 8 weeks

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for migraines include triptans, such as sumatriptan, and CGRP inhibitors. Triptans work primarily by causing vasoconstriction of dilated blood vessels and inhibiting the release of inflammatory neuropeptides, which helps alleviate migraine symptoms. CGRP inhibitors, on the other hand, block the activity of the calcitonin gene-related peptide (CGRP), a molecule involved in the transmission of pain and the dilation of blood vessels during a migraine attack. Understanding these mechanisms is crucial for migraine patients as it helps in selecting the most effective treatment based on their specific symptoms and the underlying pathophysiology of their migraines.

Clinical and experimental effects of sumatriptan in humans.Pharmacological treatment of migraine: CGRP and 5-HT beyond the triptans.How to Apply the AHS Evidence Assessment of the Acute Treatment of Migraine in Adults to your Patient with Migraine.