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)
1 other identifier
interventional
88
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2022
Shorter than P25 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 6, 2022
CompletedFirst Submitted
Initial submission to the registry
December 19, 2022
CompletedFirst Posted
Study publicly available on registry
January 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2023
CompletedResults Posted
Study results publicly available
February 25, 2025
CompletedFebruary 25, 2025
February 1, 2025
10 months
December 19, 2022
February 4, 2025
February 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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)
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)
Patient Global Impression of Change (PGIC)
Visit 5 (Week 12)
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 Migraine Headache Days
Last 28 days before Visit 2 (Day 1) and average per 28 days over 12-week Treatment Period
- +1 more secondary outcomes
Study Arms (3)
TNX-1900 High Dose
EXPERIMENTAL30 IU oxytocin taken intranasally twice daily.
TNX-1900 Low Dose
EXPERIMENTAL30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily.
Placebo
PLACEBO COMPARATORPlacebo taken intranasally twice daily.
Interventions
Patients will spray TNX-1900 once into each nostril.
Patients will spray placebo nasal spray once into each nostril.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tonix Pharmaceuticals, Inc.lead
- Premiercollaborator
Study Sites (26)
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211, United States
Synergy Research Centers - Synergy San Diego
Lemon Grove, California, 91945, United States
Excell Research
Oceanside, California, 92056, United States
Viking Clinical Research, LTD
Temecula, California, 92591, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Segal Trials - Miami Lakes Medical Research Outpatient Site
Miami Lakes, Florida, 33016, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Diamond Headache Clinic
Chicago, Illinois, 60642, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265, United States
Alliance for Multispecialty Research - Wichita West
Wichita, Kansas, 67205, United States
DelRicht Research - LCMC Health Urgent Care
New Orleans, Louisiana, 70124, United States
DelRicht Research - Neighborhood Health
Prairieville, Louisiana, 70769, United States
Boston Clinical Trials, Inc.
Boston, Massachusetts, 02131, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, 48104, United States
DelRicht Research - Gulfport Memorial
Gulfport, Mississippi, 39501, United States
Clinvest Research
Springfield, Missouri, 65807, United States
Alliance for Multispecialty Research - Las Vegas
Las Vegas, Nevada, 89119, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, 14221, United States
Peters Medical Research
High Point, North Carolina, 27260, United States
IPS Research Company, INC.
Oklahoma City, Oklahoma, 73106, United States
DelRicht Research - Grassroots Healthcare
Tulsa, Oklahoma, 74133, United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Austin Clinical Trial Partners
Austin, Texas, 78737, United States
Charlottesville Medical Research, LLC
Charlottesville, Virginia, 22911, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, 53144, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gregory Sullivan
- Organization
- Tonix Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Gregory Sullivan, MD
Tonix Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2022
First Posted
January 11, 2023
Study Start
December 6, 2022
Primary Completion
October 8, 2023
Study Completion
October 23, 2023
Last Updated
February 25, 2025
Results First Posted
February 25, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share