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

Phase 2

Completed

Conditions: Chronic Migraine
Chronic Migraine, Headache
Chronic Migraine Without Aura
Aura Migraine

Interventions: Drug: TNX-1900
Drug: Placebo Nasal Spray

Registration Number: NCT05679908

Lead Sponsor: Tonix Pharmaceuticals, Inc.

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 88

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNX-1900 Low Dose	TNX-1900	30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily.
TNX-1900 Low Dose	Placebo Nasal Spray	30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily.
TNX-1900 High Dose	TNX-1900	30 IU oxytocin taken intranasally twice daily.
Placebo	Placebo Nasal Spray	Placebo taken intranasally twice daily.

Primary Outcome Measures

Name	Time	Method
Mean Change in the Number of Monthly Migraine Headache Days	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 Outcome Measures

Name	Time	Method
Mean Change in the Number of Days Using Rescue Medication	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.
Patient Global Impression of Change (PGIC)	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.
Proportion of Patients Experiencing a ≥ 50% Reduction in the Number of Migraine Headache Days	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
Mean Change in the Number of Moderate or Severe Headache Days	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.
Mean Change in the Number of Migraine Headache Days	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.
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire	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.

Trial Locations

Locations (24): Coastal Carolina Research Center
🇺🇸
North Charleston, South Carolina, United States
Clinical Investigation Specialists, Inc.
🇺🇸
Kenosha, Wisconsin, United States
Alliance for Multispecialty Research - Wichita West
🇺🇸
Wichita, Kansas, United States
Preferred Research Partners, Inc.
🇺🇸
Little Rock, Arkansas, United States
Synergy Research Centers - Synergy San Diego
🇺🇸
Lemon Grove, California, United States
Excell Research
🇺🇸
Oceanside, California, United States
Viking Clinical Research, LTD
🇺🇸
Temecula, California, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸
Memphis, Tennessee, United States
Segal Trials - Miami Lakes Medical Research Outpatient Site
🇺🇸
Miami Lakes, Florida, United States
Diamond Headache Clinic
🇺🇸
Chicago, Illinois, United States
Integrated Clinical Trial Services, Inc.
🇺🇸
West Des Moines, Iowa, United States
DelRicht Research - LCMC Health Urgent Care
🇺🇸
New Orleans, Louisiana, United States
Michigan Headache & Neurological Institute
🇺🇸
Ann Arbor, Michigan, United States
DelRicht Research - Gulfport Memorial
🇺🇸
Gulfport, Mississippi, United States
Boston Clinical Trials, Inc.
🇺🇸
Boston, Massachusetts, United States
DelRicht Research - Neighborhood Health
🇺🇸
Prairieville, Louisiana, United States
Peters Medical Research
🇺🇸
High Point, North Carolina, United States
IPS Research Company, INC.
🇺🇸
Oklahoma City, Oklahoma, United States
Clinvest Research
🇺🇸
Springfield, Missouri, United States
Alliance for Multispecialty Research - Las Vegas
🇺🇸
Las Vegas, Nevada, United States
Upstate Clinical Research Associates, LLC
🇺🇸
Williamsville, New York, United States
Austin Clinical Trial Partners
🇺🇸
Austin, Texas, United States
Charlottesville Medical Research, LLC
🇺🇸
Charlottesville, Virginia, United States
DelRicht Research - Grassroots Healthcare
🇺🇸
Tulsa, Oklahoma, United States