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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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of cluster headaches.
Select...
I have had headaches on most days for the last 6 months.
Select...
I have used opiates or barbiturates regularly for the past 3 months.
Select...
I use over-the-counter nasal products like saline sprays.
Select...
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
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 moreTrial 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
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.
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.
Find a Location
Who is running the clinical trial?
Tonix Pharmaceuticals, Inc.Lead Sponsor
30 Previous Clinical Trials
4,969 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
Eligibility Criteria:
This trial includes the following eligibility 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.I have a history of cluster headaches.I have tried 3 or more migraine preventives without success.I use over-the-counter nasal products like saline sprays.I have had migraines for over a year, starting before I was 50, and they've been chronic for the last 3 months.I stopped my anti-CGRP treatment or study at least 4 months ago.I am between 18 and 65 years old.I am on no more than one preventive migraine medication and can maintain this during the study.
Research Study Groups:
This trial has the following groups:- Group 1: TNX-1900 High Dose
- Group 2: TNX-1900 Low Dose
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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