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

Chronic Migraine Clinical Trial

— PREVENTION  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05679908
• Other study ID #: TNX-OX-CM201
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Migraine
• Chronic Migraine, Headache
• Headache
• Migraine Disorders
• Migraine with Aura
• Migraine without Aura

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)