What side effects are associated with this type of intervention?

Common treatments for migraines include triptans, neuromodulation devices, and noninvasive vagus nerve stimulation. Triptans, such as sumatriptan, can cause side effects like vasoconstriction, potential cardiac issues, and headache recurrence within 24 hours. Neuromodulation devices, including transcranial magnetic stimulation (TMS) and remote electrical neuromodulation (REN), have been associated with mild adverse events such as warm sensations, numbness, redness, itching, tingling, and muscle spasms, but no serious adverse events. Noninvasive vagus nerve stimulation may also be beneficial with a similar profile of mild side effects. These treatments offer various mechanisms of action and side effect profiles, providing multiple options for managing migraines.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine, including triptans like sumatriptan and eletriptan, which are commonly used for acute migraine relief. Neuromodulation devices, such as transcranial magnetic stimulation (TMS) and remote electrical neuromodulation, have also received FDA approval for their efficacy in treating migraines. Additionally, dihydroergotamine, an ergot derivative, is approved for acute migraine treatment. These treatments offer various mechanisms of action, from vasoconstriction to neural stimulation, providing multiple options for migraine management.

What other types of research exist?

Promising novel alternatives to TNX-1900 for migraine treatment include: 1) CGRP receptor antagonists, which target the calcitonin gene-related peptide system and have shown efficacy in clinical trials. 2) NOS inhibitors, which target nitric oxide synthase and are in early clinical development. 3) E-TNS (external trigeminal nerve stimulation), a non-invasive, non-pharmacological option that has proven effective in clinical trials. 4) Lasmiditan, a serotonin receptor agonist approved for acute migraine treatment. These alternatives offer diverse mechanisms of action and have demonstrated potential in recent studies.

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TNX-1900 for Chronic Migraine (PREVENTION Trial)

Phase 2

Waitlist Available

Research Sponsored by Tonix Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women aged 18 to 65 years, inclusive, at the time of Visit 1

History of migraine with or without aura for at least 1 year and onset at < 50 years of age. Patient must also have a history of chronic migraine > 3 months prior to Visit 1 as defined by IHS ICHD-3

Must not have

History of cluster headache

Presence of headaches more than 26 days a month on average for the 6 months prior to Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up last 28 days before visit 2 (day 1) and last 28 days before visit 5 (week 12)

Summary

This trial is testing two doses of a medication called TNX-1900 to see if it helps people who have frequent and severe migraines. The study will compare the effects of the medication to determine its effectiveness and safety.

Who is the study for?

Adults aged 18-65 with a history of chronic migraine for over a year, who may be on up to one preventive medication. Excluded are those with cluster headaches, headache frequency above 26 days per month, no benefit from three prior preventives, excessive opiate or barbiturate use, recent anti-CGRP treatments or need for intranasal corticosteroids.

What is being tested?

The trial is testing TNX-1900 at two doses (30 IU and 60 IU daily) against a placebo nasal spray to see which is better at treating chronic migraines. Participants will not know if they're getting the real treatment or the placebo.

What are the potential side effects?

While specific side effects of TNX-1900 aren't listed here, common ones in nasal sprays can include nasal irritation or discomfort, sneezing, nosebleeds, runny nose and possibly systemic effects depending on the drug's nature.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have had migraines for over a year, starting before I was 50, and they've been chronic for the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of cluster headaches.

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I have had headaches on most days for the last 6 months.

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I have used opiates or barbiturates regularly for the past 3 months.

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I use over-the-counter nasal products like saline sprays.

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I haven't used nasal sprays for allergies in the last 28 days and won't during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ last 28 days before visit 2 (day 1) and average per 28 days over 12-week treatment period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~last 28 days before visit 2 (day 1) and average per 28 days over 12-week treatment period

This trial's timeline: 3 weeks for screening, Varies for treatment, and last 28 days before visit 2 (day 1) and average per 28 days over 12-week treatment period for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean change in the number of monthly migraine headache days

Secondary study objectives

Mean change from Baseline in the Migraine-Specific Quality of Life Questionnaire

Mean change in the number of days using rescue medication

Mean change in the number of migraine headache days

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: TNX-1900 Low DoseExperimental Treatment2 Interventions

30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily.

Group II: TNX-1900 High DoseExperimental Treatment1 Intervention

30 IU oxytocin taken intranasally twice daily.

Group III: PlaceboPlacebo Group1 Intervention

Placebo taken intranasally twice daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo Nasal Spray

2006

Completed Phase 3

~3780

TNX-1900

2022

Completed Phase 2

~90

0 / 7Eligibility criteria met

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 work through various mechanisms. Botulinum toxin type A, for example, is believed to alleviate migraines by inhibiting the release of neurotransmitters involved in pain pathways, thus reducing central sensitization. Sumatriptan, a triptan, works by stimulating serotonin receptors, leading to vasoconstriction and inhibition of pro-inflammatory neuropeptide release, which helps in reducing headache pain. Understanding these mechanisms is crucial for migraine patients as it helps in selecting the most effective treatment tailored to their specific pathophysiological profile, potentially improving outcomes and reducing the frequency and severity of migraine attacks.

Clinical and experimental effects of sumatriptan in humans.Pharmacological treatment of migraine: CGRP and 5-HT beyond the triptans.Update on the Pharmacological Treatment of Chronic Migraine.