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Chronic MigrainePhase 2PREVENTIONNCT05679908

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

A Phase 2 study testing TNX-1900 in people with Chronic Migraine and Chronic Migraine, Headache, run by Tonix Pharmaceuticals, Inc. at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
TNX-1900
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
26 sitesUnited States
Study dates
6 Dec 2022to 23 Oct 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan, 48104

  • Austin Clinical Trial Partners

    Austin, Texas, 78737

  • Boston Clinical Trials, Inc.

    Boston, Massachusetts, 02131

  • Charlottesville Medical Research, LLC

    Charlottesville, Virginia, 22911

  • Diamond Headache Clinic

    Chicago, Illinois, 60642

  • DelRicht Research - Gulfport Memorial

    Gulfport, Mississippi, 39501

  • Peters Medical Research

    High Point, North Carolina, 27260

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Clinical Investigation Specialists, Inc.

    Kenosha, Wisconsin, 53144

  • Alliance for Multispecialty Research - Las Vegas

    Las Vegas, Nevada, 89119

  • Synergy Research Centers - Synergy San Diego

    Lemon Grove, California, 91945

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Segal Trials - Miami Lakes Medical Research Outpatient Site

    Miami Lakes, Florida, 33016

  • DelRicht Research - LCMC Health Urgent Care

    New Orleans, Louisiana, 70124

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Excell Research

    Oceanside, California, 92056

  • IPS Research Company, INC.

    Oklahoma City, Oklahoma, 73106

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • DelRicht Research - Neighborhood Health

    Prairieville, Louisiana, 70769

  • Clinvest Research

    Springfield, Missouri, 65807

  • Viking Clinical Research, LTD

    Temecula, California, 92591

  • DelRicht Research - Grassroots Healthcare

    Tulsa, Oklahoma, 74133

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265

  • Alliance for Multispecialty Research - Wichita West

    Wichita, Kansas, 67205

  • Upstate Clinical Research Associates, LLC

    Williamsville, New York, 14221

Other trials in United States

About this study

Official title: A Phase 2, Double-blind, Randomized, Multicenter, Placebo-controlled, Three Arm Parallel Study to Evaluate the Efficacy and Safety of TNX-1900 (Intranasal Oxytocin) in Patients With Chronic Migraine (PREVENTION Study)

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.

Being tested
TNX-1900, Placebo Nasal Spray
Keywords
Migraine, Chronic Migraine, Headache, Chronic Migraine Without Aura, Aura Migraine
Medical subject headings
Headache, Migraine with Aura, Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TNX-1900Drug

    Also called intranasal oxytocin

    Patients will spray TNX-1900 once into each nostril.

  • Placebo Nasal SprayDrug

    Patients will spray placebo nasal spray once into each nostril.

Study groups in NCT05679908
Study groupRoleWhat they receive
TNX-1900 High DoseExperimental30 IU oxytocin taken intranasally twice daily.
Receives: Drug: TNX-1900
TNX-1900 Low DoseExperimental30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily.
Receives: Drug: TNX-1900; Drug: Placebo Nasal Spray
PlaceboPlacebo comparatorPlacebo taken intranasally twice daily.
Receives: Drug: Placebo Nasal Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)

Secondary outcomes (6)

  1. 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

    Measured: Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)

  2. 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.

    Measured: Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)

  3. 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.

    Measured: Visit 5 (Week 12)

  4. 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.

    Measured: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)

  5. 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.

    Measured: Last 28 days before Visit 2 (Day 1) and average per 28 days over 12-week Treatment Period

  6. 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.

    Measured: Visit 2 (Day 1) and Visit 5 (Week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2023
  2. Study start6 Dec 2022
  3. Primary completion8 Oct 2023
  4. Study completion23 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05679908
Sponsor's protocol ID
TNX-OX-CM201
Acronym
PREVENTION
Status last verified
Feb 2025
First submitted
19 Dec 2022
Last updated
25 Feb 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TNX-1900 in people with Chronic Migraine and Chronic Migraine, Headache, run by Tonix Pharmaceuticals, Inc. at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05679908.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.

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