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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Migraine; Chronic Migraine, Headache; Chronic Migraine Without Aura; Aura Migraine
• Intervention / Treatment: Drug: TNX-1900; Drug: Placebo Nasal Spray

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TNX-1900 High Dose; 30 IU oxytocin taken intranasally twice daily.	Drug: TNX-1900; Patients will spray TNX-1900 once into each nostril.; Other Names: intranasal oxytocin
Experimental: TNX-1900 Low Dose; 30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily.	Drug: TNX-1900; Patients will spray TNX-1900 once into each nostril.; Other Names: intranasal oxytocin; Drug: Placebo Nasal Spray; Patients will spray placebo nasal spray once into each nostril.
Placebo Comparator: Placebo; Placebo taken intranasally twice daily.	Drug: Placebo Nasal Spray; Patients will spray placebo nasal spray once into each nostril.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Visit 5 (Week 12)
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	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.	Last 28 days before Visit 2 (Day 1) treatment and last 28 days before 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.	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.	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.	Visit 2 (Day 1) and Visit 5 (Week 12)

Collaborators and Investigators

• Sponsor: Tonix Pharmaceuticals, Inc.
• Collaborators: Premier
• Investigators: Study Director: Gregory Sullivan, MD, Tonix Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Actual): October 8, 2023
• Study Completion (Actual): October 23, 2023

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Migraine; Headache; Chronic Migraine; Chronic Migraine Without Aura; Aura Migraine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Migraine with Aura; Epilepsy; Migraine without Aura; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: TNX-OX-CM201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No