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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05679908
Other study ID # TNX-OX-CM201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 6, 2022
Est. completion date October 23, 2023

Study information

Verified date March 2024
Source Tonix Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date October 23, 2023
Est. primary completion date October 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 ß-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


Intervention

Drug:
TNX-1900
Patients will spray TNX-1900 once into each nostril.
Placebo Nasal Spray
Patients will spray placebo nasal spray once into each nostril.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Tonix Pharmaceuticals, Inc. Premier

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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
Secondary 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)
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