TNX-1900 for Chronic Migraine

(PREVENTION Trial)

Recruiting at 26 trial locations

Overseen By Clinical Trial Associate

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Tonix Pharmaceuticals, Inc.

Must not be taking: Opiates, Barbiturates, Intranasal corticosteroids

Disqualifiers: Cluster headache, Frequent headaches, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

88 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You can stay on one stable preventive medication and any number of abortive migraine medications during the study. However, you cannot start or stop any preventive treatments during the study. If you use intranasal corticosteroids, you must stop them at least 28 days before the study begins.

What safety data exists for TNX-1900 or similar treatments for chronic migraine?

The available research on novel migraine treatments, including those targeting similar pathways as TNX-1900, suggests they are generally safe and effective for managing migraines. However, specific safety data for TNX-1900 itself is not detailed in the provided studies. ^{1 2 3 4 5}

Research Team

Gregory Sullivan, MD

Principal Investigator

Tonix Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

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

I am on no more than one preventive migraine medication and can maintain this during the study.

Exclusion Criteria

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

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TNX-1900 or placebo intranasally for 12 weeks

12 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo Nasal Spray
• TNX-1900

Trial Overview 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.

Participant Groups

Group I: TNX-1900 Low Dose Experimental Treatment 2 Interventions

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

Group II: TNX-1900 High Dose Experimental Treatment 1 Intervention

30 IU oxytocin taken intranasally twice daily.

Group III: Placebo Placebo Group 1 Intervention

Placebo taken intranasally twice daily.

Who Is Running the Clinical Trial?

Tonix Pharmaceuticals, Inc.

Lead Sponsor

Trials

31

Recruited

4,900+

Premier

Collaborator

Trials

2

Recruited

120+

Findings from Research

In a 52-week trial involving 744 adults with migraine, daily oral atogepant 60 mg was found to be safe and well-tolerated, with 67% of participants experiencing treatment-emergent adverse events, mostly mild to moderate.

Atogepant significantly reduced the mean monthly migraine days, with 84.2% of participants achieving at least a 50% reduction in migraine frequency by the end of the study, demonstrating its efficacy as a preventive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-daily oral atogepant for the long-term preventive treatment of migraine: Findings from a multicenter, randomized, open-label, phase 3 trial. Ashina, M., Tepper, SJ., Reuter, U., et al.[2023]

A review of 73 migraine drug trials published between 2010 and 2015 found that while a majority reported adverse events, only 41% included this information in their abstracts, highlighting a gap in transparency.

The study emphasizes the need for all randomized controlled trials on migraine treatments to consistently report adverse events in their abstracts to better assess the safety and tolerability of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. Tfelt-Hansen, P., Lindqvist, JK., Do, TP.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Novel Migraine Treatments: A Review [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Once-daily oral atogepant for the long-term preventive treatment of migraine: Findings from a multicenter, randomized, open-label, phase 3 trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Benefit-risk assessment of erenumab and current migraine prophylactic treatments using the likelihood of being helped or harmed. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Galcanezumab effect on "whole pain burden" and multidimensional outcomes in migraine patients with previous unsuccessful treatments: a real-world experience. [2022]