A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine
NCT ID: NCT05679908
Last Updated: 2025-02-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2022-12-06
2023-10-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine
NCT01839149
Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache
NCT02423408
Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine
NCT01709708
Study to Assess the Safety, Tolerance and Efficacy of Tezampanel in Patients With Acute Migraine
NCT00567086
A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine
NCT00109083
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TNX-1900 High Dose
30 IU oxytocin taken intranasally twice daily.
TNX-1900
Patients will spray TNX-1900 once into each nostril.
TNX-1900 Low Dose
30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily.
TNX-1900
Patients will spray TNX-1900 once into each nostril.
Placebo Nasal Spray
Patients will spray placebo nasal spray once into each nostril.
Placebo
Placebo taken intranasally twice daily.
Placebo Nasal Spray
Patients will spray placebo nasal spray once into each nostril.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TNX-1900
Patients will spray TNX-1900 once into each nostril.
Placebo Nasal Spray
Patients will spray placebo nasal spray once into each nostril.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Premier
UNKNOWN
Tonix Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gregory Sullivan, MD
Role: STUDY_DIRECTOR
Tonix Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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.
Jacksonville, Florida, United States
Segal Trials - Miami Lakes Medical Research Outpatient Site
Miami Lakes, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Diamond Headache Clinic
Chicago, Illinois, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, United States
Alliance for Multispecialty Research - Wichita West
Wichita, Kansas, United States
DelRicht Research - LCMC Health Urgent Care
New Orleans, Louisiana, United States
DelRicht Research - Neighborhood Health
Prairieville, Louisiana, United States
Boston Clinical Trials, Inc.
Boston, Massachusetts, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, United States
DelRicht Research - Gulfport Memorial
Gulfport, Mississippi, 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
Peters Medical Research
High Point, North Carolina, United States
IPS Research Company, INC.
Oklahoma City, Oklahoma, United States
DelRicht Research - Grassroots Healthcare
Tulsa, Oklahoma, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Austin Clinical Trial Partners
Austin, Texas, United States
Charlottesville Medical Research, LLC
Charlottesville, Virginia, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TNX-OX-CM201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.