Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine

Short name PREVENTION

NCTNCT05679908Other idTNX-OX-CM201

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 88 participants (actual)
Sponsor: Tonix Pharmaceuticals, Inc. · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 6 Dec 2022
Primary completion: 8 Oct 2023
Completion: 23 Oct 2023
First posted: 11 Jan 2023
Last update posted: 25 Feb 2025
Conditions: Chronic Migraine · Chronic Migraine, Headache · Chronic Migraine Without Aura · Aura Migraine

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202220232024

Ph 2
PREVENTION
NCT05679908
6 Dec 2022 to 23 Oct 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a phase 2, double-blind, randomized, multicenter, placebo-controlled, three arm parallel study to evaluate the efficacy and safety of two different dosages (30 IU daily and 60 IU daily) of TNX-1900 in patients with chronic migraine.

Interventions

TNX-1900Drug
Placebo Nasal SprayDrug

Arms3

Experimental
TNX-1900 High Dose
30 IU oxytocin taken intranasally twice daily.
Experimental
TNX-1900 Low Dose
30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily.
Placebo comparator
Placebo
Placebo taken intranasally twice daily.

Primary outcomes1

Outcomes the sponsor listed as primary.

Mean Change in the Number of Monthly Migraine Headache Days
Time frame · Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)
Registry description
Mean change in the number of monthly migraine headache days from the last 28 days of Baseline to the last 28 days of treatment (ie, month 3). A migraine headache day is any calendar day (0:00 to 23:59) in which the patient records in the e-diary: * An attack lasting 4 hours or more and meeting the ICHD-3 criteria for migraine without aura, or * A migraine with aura, or * An attack that meets ICHD-3 criteria for probable migraine, (a migraine subtype fulfilling all but one criteria (B-D) for migraine without aura), or * An attack of any duration that was believed by the patient to be a migraine and was relieved by a triptan, ergot derivative, or other migraine-specific abortive medication.

Secondary outcomes(6)

Proportion of Patients Experiencing a ≥ 50% Reduction in the Number of Migraine Headache Days
Time frame · Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)
Registry description
Proportion of patients experiencing a ≥ 50% reduction in the number of migraine headache days from the last 28 days of Baseline to the last 28 days of treatment in each treatment group
Mean Change in the Number of Days Using Rescue Medication
Time frame · Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)
Registry description
Mean change in the number of days using rescue medication (triptan, ergot derivative, or other migraine-specific acute medication) from the last 28 days of Baseline to the last 28 days of treatment.
Patient Global Impression of Change (PGIC)
Time frame · Visit 5 (Week 12)
Registry description
Proportion of patients with a Patient Global Impression of Change (PGIC) of 1, "very much improved", or 2, "much improved", at Week 12. Scores range from 1 to 7. Lower scores indicate more improvement.
Mean Change in the Number of Moderate or Severe Headache Days
Time frame · Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)
Registry description
Mean change in the number of moderate or severe headache days from the last 28 days of Baseline to the last 28 days of treatment. A moderate or severe headache day is defined as any calendar day wherein a patient records a headache or migraine of moderate or severe peak intensity in the e-diary.
Mean Change in the Number of Migraine Headache Days
Time frame · Last 28 days before Visit 2 (Day 1) and average per 28 days over 12-week Treatment Period
Registry description
Mean change in the number of migraine headache days from the last 28 days of Baseline to average number per 28 days over the entire 12-week duration of Treatment Period.
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire
Time frame · Visit 2 (Day 1) and Visit 5 (Week 12)
Registry description
Mean change from Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) at Week 12. Scores range from 0 to 100. Higher scores indicate better quality of life.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)

Mean Change in the Number of Monthly Migraine Headache Days

Group	Value (number of days)	Spread
Placebo	-8.17	1.366
TNX-1900 Low Dose	-7.78	1.246
TNX-1900 High Dose	-5.77	1.301

Secondary and other outcome results(6)

Secondary outcomeCount of participants· Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)

Proportion of Patients Experiencing a ≥ 50% Reduction in the Number of Migraine Headache Days

Group	Value (Participants)
Placebo	15
TNX-1900 Low Dose	15
TNX-1900 High Dose	10

Secondary outcomeLeast squares mean· Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)

Mean Change in the Number of Days Using Rescue Medication

Group	Value (days)	Spread
Placebo	-3.16	.749
TNX-1900 Low Dose	-4.09	.687
TNX-1900 High Dose	-2.07	.715

Secondary outcomeCount of participants· Visit 5 (Week 12)

Patient Global Impression of Change (PGIC)

Group	Value (Participants)
Placebo	12
TNX-1900 Low Dose	16
TNX-1900 High Dose	14

Secondary outcomeLeast squares mean· Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)

Mean Change in the Number of Moderate or Severe Headache Days

Group	Value (days)	Spread
Placebo	-8.39	1.372
TNX-1900 Low Dose	-8.17	1.236
TNX-1900 High Dose	-5.00	1.304

Secondary outcomeLeast squares mean· Last 28 days before Visit 2 (Day 1) and average per 28 days over 12-week Treatment Period

Mean Change in the Number of Migraine Headache Days

Group	Value (days)	Spread
Placebo	-7.09	1.208
TNX-1900 Low Dose	-6.67	1.063
TNX-1900 High Dose	-5.24	1.146

Secondary outcomeLeast squares mean· Visit 2 (Day 1) and Visit 5 (Week 12)

Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire

Group	Value (units on a scale)	Spread
Placebo	26.07	4.154
TNX-1900 Low Dose	28.98	3.727
TNX-1900 High Dose	21.10	3.928

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PlaceboPlacebo taken intranasally twice daily. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	0 / 27	0 / 27	6 / 27
TNX-1900 Low Dose30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily. TNX-1900: Patients will spray TNX-1900 once into each nostril. Placebo Nasal Spray: Patients will spray placebo nasal spray once into each nostril.	0 / 31	0 / 31	10 / 31
TNX-1900 High Dose30 IU oxytocin taken intranasally twice daily. TNX-1900: Patients will spray TNX-1900 once into each nostril.	0 / 30	0 / 30	5 / 30

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Major Inclusion Criteria: * 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 * Patients can be on stable ≤ 1 preventive medication and any number of abortive migraine medications for 90 days prior to Screening and during the study. All treatments, other than the study drug, thought to have preventive efficacy in migraine should not be started or discontinued during the entire study period. Note: Up to approximately 30% of the patients randomized into the study can be on 1 preventative medication. Once this category is filled, only patients who are not on any preventative medications can be randomized into the study. Major Exclusion Criteria: * History of cluster headache. * Presence of headaches more than 26 days a month on average for the 6 months prior to Screening. * Failed to benefit from an adequate dose and duration, in the investigator's judgment (eg, one month of β-blocker), of 3 or more migraine preventive medications. * Use of opiates or barbiturates more than 4 days per month for more than 3 consecutive months prior to Visit 1 and during the study. * Use of over-the-counter (OTC) nasal products (ie, saline spray, Neti-Pot, Naväge® etc.) during the study. * Any use of intranasal corticosteroid medications or conditions in which use of intranasal corticosteroids may be indicated during the study, eg, unstable allergic rhinitis that has previously required intranasal corticosteroids. Intranasal corticosteroid use is not allowed within 28 days of Baseline/Randomization/Visit 2 and during the treatment phase or follow-up period of the study. * Patients who recently discontinued treatment with an anti-calcitonin-gene-related peptide (CGRP) or participated in anti-CGRP clinical study must be at least 4 months from the last drug administration prior to Visit 1.

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