CompletedNCT05679908PREVENTIONUpdated Feb 25, 2025Results posted

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

A Phase 2 interventional study of TNX-1900 and Placebo Nasal Spray in Chronic Migraine, Chronic Migraine, Headache and Chronic Migraine Without Aura, sponsored by Tonix Pharmaceuticals, Inc.. Completed at 26 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-25.

Sponsored by Tonix Pharmaceuticals, Inc. · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 88
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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.

Conditions studied

Chronic Migraine
Chronic Migraine, Headache
Chronic Migraine Without Aura
Aura Migraine

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Keywords

Migraine
Chronic Migraine
Headache
Chronic Migraine Without Aura
Aura Migraine

In context

Headache

762 studies on the registry are indexed under Headache; 134 are open to participants now.

This study's enrollment of 88 is above the median of 65 across 560 interventional studies indexed under Headache.

Browse Headache studies →

Lead sponsor

Tonix Pharmaceuticals, Inc. is the lead sponsor of 34 studies on the registry; 1 is open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.

Browse Tonix Pharmaceuticals, Inc. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 88 participants (actual)

Study arms

Experimental
TNX-1900 High Dose
30 IU oxytocin taken intranasally twice daily.
Drug: TNX-1900
Experimental
TNX-1900 Low Dose
30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily.
Drug: TNX-1900 · Drug: Placebo Nasal Spray
Placebo comparator
Placebo
Placebo taken intranasally twice daily.
Drug: Placebo Nasal Spray

Interventions

DrugTNX-1900
Patients will spray TNX-1900 once into each nostril.
Also known as: intranasal oxytocin
DrugPlacebo Nasal Spray
Patients will spray placebo nasal spray once into each nostril.

What researchers measure

Primary outcomes

Mean Change in the Number of Monthly Migraine Headache Days
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.
Time frame: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)

Secondary outcomes

Proportion of Patients Experiencing a ≥ 50% Reduction in the Number of Migraine Headache Days
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
Time frame: 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
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.
Time frame: Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)
Patient Global Impression of Change (PGIC)
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.
Time frame: Visit 5 (Week 12)
Mean Change in the Number of Moderate or Severe Headache Days
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.
Time frame: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)
Mean Change in the Number of Migraine Headache Days
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.
Time frame: Last 28 days before Visit 2 (Day 1) and average per 28 days over 12-week Treatment Period
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire
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.
Time frame: Visit 2 (Day 1) and Visit 5 (Week 12)

Results

Posted Feb 25, 2025

Participant flow

Participant flow — Overall Study
Milestone	Placebo	TNX-1900 Low Dose	TNX-1900 High Dose
Started	27	31	30
Completed	25	26	27
Not completed	2	5	3

Outcome measures

PrimaryMean Change in the Number of Monthly Migraine Headache Days

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.

Time frame:: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)
Reported as:: Least squares mean · number of days

Mean Change in the Number of Monthly Migraine Headache Days
number of days	Placebo	TNX-1900 Low Dose	TNX-1900 High Dose
Mean Change in the Number of Monthly Migraine Headache Days	-8.17 ± 1.366	-7.78 ± 1.246	-5.77 ± 1.301

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

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

Time frame:: Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)
Reported as:: Count of participants · Participants

Proportion of Patients Experiencing a ≥ 50% Reduction in the Number of Migraine Headache Days
Participants	Placebo	TNX-1900 Low Dose	TNX-1900 High Dose
Proportion of Patients Experiencing a ≥ 50% Reduction in the Number of Migraine Headache Days	15	15	10

SecondaryMean Change in the Number of Days Using Rescue Medication

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.

Time frame:: Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)
Reported as:: Least squares mean · days

Mean Change in the Number of Days Using Rescue Medication
days	Placebo	TNX-1900 Low Dose	TNX-1900 High Dose
Mean Change in the Number of Days Using Rescue Medication	-3.16 ± .749	-4.09 ± .687	-2.07 ± .715

SecondaryPatient Global Impression of Change (PGIC)

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.

Time frame:: Visit 5 (Week 12)
Reported as:: Count of participants · Participants

Patient Global Impression of Change (PGIC)
Participants	Placebo	TNX-1900 Low Dose	TNX-1900 High Dose
Patient Global Impression of Change (PGIC)	12	16	14

SecondaryMean Change in the Number of Moderate or Severe Headache Days

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.

Time frame:: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)
Reported as:: Least squares mean · days

Mean Change in the Number of Moderate or Severe Headache Days
days	Placebo	TNX-1900 Low Dose	TNX-1900 High Dose
Mean Change in the Number of Moderate or Severe Headache Days	-8.39 ± 1.372	-8.17 ± 1.236	-5.00 ± 1.304

SecondaryMean Change in the Number of Migraine Headache Days

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.

Time frame:: Last 28 days before Visit 2 (Day 1) and average per 28 days over 12-week Treatment Period
Reported as:: Least squares mean · days

Mean Change in the Number of Migraine Headache Days
days	Placebo	TNX-1900 Low Dose	TNX-1900 High Dose
Mean Change in the Number of Migraine Headache Days	-7.09 ± 1.208	-6.67 ± 1.063	-5.24 ± 1.146

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

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.

Time frame:: Visit 2 (Day 1) and Visit 5 (Week 12)
Reported as:: Least squares mean · units on a scale

Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire
units on a scale	Placebo	TNX-1900 Low Dose	TNX-1900 High Dose
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire	26.07 ± 4.154	28.98 ± 3.727	21.10 ± 3.928

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	0/27 (0%)	0/27 (0%)	6/27 (22.2%)
TNX-1900 Low Dose	0/31 (0%)	0/31 (0%)	10/31 (32.3%)
TNX-1900 High Dose	0/30 (0%)	0/30 (0%)	5/30 (16.7%)

Most frequent other events

Most frequent other events
Event	Placebo	TNX-1900 Low Dose	TNX-1900 High Dose
Nasal discomfortRespiratory, thoracic and mediastinal disorders	6/27	10/31	5/30
Nasal mucosal disorderRespiratory, thoracic and mediastinal disorders	3/27	5/31	3/30
RhinalgiaRespiratory, thoracic and mediastinal disorders	2/27	0/31	0/30
EpistaxisRespiratory, thoracic and mediastinal disorders	0/27	2/31	1/30
NeutropeniaBlood and lymphatic system disorders	0/27	2/31	0/30
MigraineNervous system disorders	0/27	2/31	0/30
Product after tasteProduct Issues	0/27	2/31	0/30

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo	TNX-1900 Low Dose	TNX-1900 High Dose	Total
Mean	42.2 ± 10.61	40.0 ± 10.93	44.1 ± 11.43	42.1 ± 11.02

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	TNX-1900 Low Dose	TNX-1900 High Dose	Total
Female	6	4	2	12
Male	21	27	28	76

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo	TNX-1900 Low Dose	TNX-1900 High Dose	Total
Hispanic or Latino	6	4	2	12
Not Hispanic or Latino	21	27	28	76
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo	TNX-1900 Low Dose	TNX-1900 High Dose	Total
American Indian or Alaska Native	1	1	0	2
Asian	0	1	1	2
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	2	6	6	14
White	24	22	22	68
More than one race	0	0	1	1
Unknown or Not Reported	0	1	0	1

Region of Enrollment
Region of Enrollment(participants)	Placebo	TNX-1900 Low Dose	TNX-1900 High Dose	Total
United States	27	31	30	88

Study locations

26 sites

Preferred Research Partners, Inc.
Little Rock, Arkansas 72211, United States
Synergy Research Centers - Synergy San Diego
Lemon Grove, California 91945, United States
Excell Research
Oceanside, California 92056, United States
Viking Clinical Research, LTD
Temecula, California 92591, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida 32256, United States
Segal Trials - Miami Lakes Medical Research Outpatient Site
Miami Lakes, Florida 33016, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801, United States
Diamond Headache Clinic
Chicago, Illinois 60642, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa 50265, United States
Alliance for Multispecialty Research - Wichita West
Wichita, Kansas 67205, United States
DelRicht Research - LCMC Health Urgent Care
New Orleans, Louisiana 70124, United States
DelRicht Research - Neighborhood Health
Prairieville, Louisiana 70769, United States
Boston Clinical Trials, Inc.
Boston, Massachusetts 02131, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan 48104, United States
DelRicht Research - Gulfport Memorial
Gulfport, Mississippi 39501, United States
Clinvest Research
Springfield, Missouri 65807, United States
Alliance for Multispecialty Research - Las Vegas
Las Vegas, Nevada 89119, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York 14221, United States
Peters Medical Research
High Point, North Carolina 27260, United States
IPS Research Company, INC.
Oklahoma City, Oklahoma 73106, United States
DelRicht Research - Grassroots Healthcare
Tulsa, Oklahoma 74133, United States
Coastal Carolina Research Center
North Charleston, South Carolina 29405, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee 38119, United States
Austin Clinical Trial Partners
Austin, Texas 78737, United States
Charlottesville Medical Research, LLC
Charlottesville, Virginia 22911, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin 53144, United States

References and documents

Study documents

Study protocol ↗ · Jan 11, 2023
Statistical analysis plan ↗ · Nov 16, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2022 to primary completion in Oct 2023, 10 months.

Results were first posted in Feb 2025, 1 year 4 months after primary completion.

Of 31 phase 2 interventional studies under Headache, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 19, 2022
First posted: Jan 11, 2023
StartActual: Dec 6, 2022
Primary completionActual: Oct 8, 2023
CompletionActual: Oct 23, 2023
Results first posted: Feb 25, 2025
Last update: Feb 25, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05679908
Lead sponsor: Tonix Pharmaceuticals, Inc.
Collaborators: Premier
Responsible party: Sponsor
First posted: Jan 11, 2023
Start date: Dec 6, 2022
Primary completion: Oct 8, 2023
Completion: Oct 23, 2023
Results posted: Feb 25, 2025
Last update: Feb 25, 2025

Study contacts

Gregory Sullivan, MD

study director · Tonix Pharmaceuticals

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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