Clinical trial NCT05679908: A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Migraine
Chronic Migraine, Headache
Chronic Migraine Without Aura
Aura Migraine
Keywords: Migraine
Chronic Migraine
Headache
Chronic Migraine Without Aura
Aura Migraine
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Premier
First posted: 2023-01-11
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change in the Number of Monthly Migraine Headache Days
timeFrame: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)
Secondary outcomes:
measure: Proportion of Patients Experiencing a ≥ 50% Reduction in the Number of Migraine Headache Days
timeFrame: Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)
measure: Mean Change in the Number of Days Using Rescue Medication
timeFrame: Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)
measure: Patient Global Impression of Change (PGIC)
timeFrame: Visit 5 (Week 12)
measure: Mean Change in the Number of Moderate or Severe Headache Days
timeFrame: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)
measure: Mean Change in the Number of Migraine Headache Days
timeFrame: Last 28 days before Visit 2 (Day 1) and average per 28 days over 12-week Treatment Period
measure: Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire
timeFrame: Visit 2 (Day 1) and Visit 5 (Week 12)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc.
state: Arkansas
city: Lemon Grove
country: United States
facility: Synergy Research Centers - Synergy San Diego
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Temecula
country: United States
facility: Viking Clinical Research, LTD
state: California
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Miami Lakes
country: United States
facility: Segal Trials - Miami Lakes Medical Research Outpatient Site
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Chicago
country: United States
facility: Diamond Headache Clinic
state: Illinois
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Wichita
country: United States
facility: Alliance for Multispecialty Research - Wichita West
state: Kansas
city: New Orleans
country: United States
facility: DelRicht Research - LCMC Health Urgent Care
state: Louisiana
city: Prairieville
country: United States
facility: DelRicht Research - Neighborhood Health
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Headache & Neurological Institute
state: Michigan
city: Gulfport
country: United States
facility: DelRicht Research - Gulfport Memorial
state: Mississippi
city: Springfield
country: United States
facility: Clinvest Research
state: Missouri
city: Las Vegas
country: United States
facility: Alliance for Multispecialty Research - Las Vegas
state: Nevada
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates, LLC
state: New York
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Oklahoma City
country: United States
facility: IPS Research Company, INC.
state: Oklahoma
city: Tulsa
country: United States
facility: DelRicht Research - Grassroots Healthcare
state: Oklahoma
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: Austin Clinical Trial Partners
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research, LLC
state: Virginia
city: Kenosha
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Wisconsin
Study officials:
affiliation: Tonix Pharmaceuticals
name: Gregory Sullivan, MD
role: STUDY_DIRECTOR
References: