TNX-1900 for Chronic Migraine

(PREVENTION Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TNX-1900 for individuals suffering from chronic migraines. It explores the effectiveness and safety of two doses of TNX-1900 compared to a placebo (a substance with no active drug). Participants will receive either a high dose, a low dose, or a placebo, all administered as a nasal spray. Those who have experienced migraines for over a year and frequent migraines for more than three months might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that TNX-1900, a nasal spray form of oxytocin, appears safe and well-tolerated in some groups. Previous studies found that regular use of nasal oxytocin was safe for generally healthy older men. This suggests it might be safe for a broader population, but more research is needed, especially for those with chronic migraines.

While TNX-1900 remains under study, oxytocin nasal spray has been tested for migraines before. The FDA has approved trials of TNX-1900, indicating it showed enough promise in earlier studies to warrant further testing. However, since this trial is in phase 2, researchers are still learning about its full safety. This phase aims to assess how well people tolerate the treatment and to identify any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic migraine?

Unlike the standard migraine treatments, which often include medications like triptans and beta-blockers, TNX-1900 is unique because it uses oxytocin, a hormone more commonly associated with social bonding and childbirth. This treatment is administered intranasally, allowing for potentially quicker absorption and action compared to oral medications. Researchers are excited about TNX-1900 because it targets migraine at a hormonal level, which could offer relief for patients who do not respond well to traditional therapies. Additionally, the different dosing options, such as high and low doses, may provide more personalized treatment strategies for managing chronic migraines.

What evidence suggests that this trial's treatments could be effective for chronic migraine?

Research shows that TNX-1900, a nasal spray containing oxytocin, may help reduce migraines. In this trial, participants will receive either a high dose or a low dose of TNX-1900, or a placebo. Studies have found that nasal oxytocin can decrease the frequency and severity of headaches. This suggests it might help with chronic migraines by calming certain brain signals. Early results also suggest that oxytocin is linked to experiencing less pain during headaches. Overall, the evidence supports the potential of TNX-1900 to effectively manage chronic migraines. ^{1 2 4 6 7}

Who Is on the Research Team?

Gregory Sullivan, MD

Principal Investigator

Tonix Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05679908

A Study to Evaluate the Efficacy and Safety of TNX-1900 in ... This is a phase 2, double-blind, randomized, multicenter, placebo-controlled, three arm parallel study to evaluate the efficacy and safety of two different ...

2. ir.tonixpharma.com ir.tonixpharma.com/news-events/press-releases/detail/1433/tonix-pharmaceuticals-completes-clinical-stage-of-phase-2

Press Releases In addition to chronic migraine, TNX-1900 will be developed for treatment of episodic migraine, binge eating disorder, craniofacial pain ...

3. neurologylive.com neurologylive.com/view/trial-intranasal-oxytocin-chronic-migraine-cleared-fda

Trial of Intranasal Oxytocin for Chronic Migraine Cleared by ... The FDA has cleared an investigational new drug application supporting initiation of a phase 2 study of TNX-1900 (intranasal potentiated oxytocin) in patients ...

4. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-efficacy-and-safety-of-tnx-1900-in-patients-with-chronic-migraine

A Study to Evaluate the Efficacy and Safety of TNX-1900 in ... This is a phase 2, double-blind, randomized, multicenter, placebo-controlled, three arm parallel study to evaluate the efficacy and safety of two different ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4417654/

Intranasal oxytocin administration is associated with ... Likewise, a recent study found that the intranasal administration of oxytocin was significantly related to reports of decreased headache frequency and pain ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8115997/

Safety and tolerability of chronic intranasal oxytocin in older men Chronic intranasal OT appears safe and well-tolerated in generally healthy older men. These findings provide support for continued human research.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01839149

Study Details | NCT01839149 | TI-001 (Intranasal Oxytocin) ... This study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine. Official Title. A ...