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NCT Number: NCT05679908

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

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.

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Key information

Conditions

Chronic Migraine Aura Migraine Brain Diseases Central Nervous System Diseases Chronic Migraine Without Aura Chronic Migraine, Headache Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Migraine with Aura Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Preferred Research Partners, Inc., Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TNX-1900

Drug

Patients will spray TNX-1900 once into each nostril.

Other names: intranasal oxytocin

Placebo nasal spray

Drug

Patients will spray placebo nasal spray once into each nostril.

Primary outcomes

  1. 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)

    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

  1. 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)

    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

  2. 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)

    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.

  3. Patient Global Impression of Change (PGIC)

    Time frame: Visit 5 (Week 12)

    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.

  4. 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)

    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.

  5. 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

    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.

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

    Time frame: Visit 2 (Day 1) and Visit 5 (Week 12)

    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.

Sponsors and collaborators

Lead sponsor

Tonix Pharmaceuticals, Inc.

Industry

Collaborators

  • Premier

Registry information

Official study 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)

Acronym: PREVENTION

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2023
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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