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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
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)
Awards & highlights

PREVENTION Trial Summary

This trial tests two doses of a new drug for people with chronic migraine to see how safe and effective it is.

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.Check my eligibility
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.See study design
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.

PREVENTION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.
Select...
I have had migraines for over a year, starting before I was 50, and they've been chronic for the last 3 months.

PREVENTION Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in the number of monthly migraine headache days
Secondary outcome measures
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

PREVENTION 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

Find a Location

Who is running the clinical trial?

Tonix Pharmaceuticals, Inc.Lead Sponsor
29 Previous Clinical Trials
4,791 Total Patients Enrolled
PremierUNKNOWN
1 Previous Clinical Trials
60 Total Patients Enrolled
Gregory Sullivan, MDStudy DirectorTonix Pharmaceuticals
7 Previous Clinical Trials
1,679 Total Patients Enrolled

Media Library

TNX-1900 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05679908 — Phase 2
Migraine Research Study Groups: TNX-1900 High Dose, TNX-1900 Low Dose, Placebo
Migraine Clinical Trial 2023: TNX-1900 Highlights & Side Effects. Trial Name: NCT05679908 — Phase 2
TNX-1900 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05679908 — Phase 2

Frequently Asked Questions

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

Are individuals below the age of sixty permitted to enroll in this experiment?

"This research study is recruiting those aged 18 or over, up to and including 65 years old."

Answered by AI

How many research institutions are currently engaged with this experiment?

"The list of 24 clinical trial sites recruiting patients includes Excell Research in Oceanside, Viking Clinical Research, LTD in Temecula and Clinical Neuroscience Solutions, Inc. in Jacksonville alongside many other facilities."

Answered by AI

What potential harms have been linked to the consumption of TNX-1900 High Dose?

"With prior safety data available, but not regarding efficacy, TNX-1900 High Dose earned a score of 2 on our 1 to 3 rating scale."

Answered by AI

Is this trial currently open to new participants?

"Clinicaltrials.gov reports that this research study is actively seeking participants, with the trial being first posted on December 6th 2022 and last revised on January 10th 2023."

Answered by AI

How many volunteers are being accepted for this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial is currently recruiting participants after being listed on December 6th 2022 and last updated on January 10th 2023. 300 patients need to be enrolled at 24 distinct locations."

Answered by AI

Am I eligible to participate in the research project?

"This research is enrolling 300 individuals aged 18-65 with chronic migraine. To qualify, participants must fulfill the following conditions: men and women between 18 and 65 years old at Screening; a history of migraines (with or without aura) for 1 year prior to Visit 1 beginning before age 50; 3+ months of chronic migraine preceding their first visit as defined by IHS ICHD-3 criteria; those on ≤ one preventative medication plus any abortive medications can be admitted, although only up to 30% may have taken an approved prophylactic drug. Additionally, no treatments believed to inhibit migraines should"

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Integrated Clinical Trial Services, Inc.
Peters Medical Research

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine
2022. "A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05679908.
All > Montreal
~38 spots leftby Apr 2025
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