Back to resultsA Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine (PREVENTION)
Primary Purpose
Chronic Migraine, Chronic Migraine, Headache, Chronic Migraine Without Aura
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TNX-1900
Placebo Nasal Spray
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Migraine focused on measuring Migraine, Chronic Migraine, Headache, Chronic Migraine Without Aura, Aura 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.
Sites / Locations
- Preferred Research Partners, Inc.
- Synergy Research Centers - Synergy San Diego
- Excell Research
- Viking Clinical Research, LTD
- Clinical Neuroscience Solutions, Inc.
- Segal Trials - Miami Lakes Medical Research Outpatient Site
- Clinical Neuroscience Solutions, Inc.
- Diamond Headache Clinic
- Integrated Clinical Trial Services, Inc.
- Alliance for Multispecialty Research - Wichita West
- DelRicht Research - LCMC Health Urgent Care
- DelRicht Research - Neighborhood Health
- Boston Clinical Trials, Inc.
- Michigan Headache & Neurological Institute
- DelRicht Research - Gulfport Memorial
- Clinvest Research
- Alliance for Multispecialty Research - Las Vegas
- Upstate Clinical Research Associates, LLC
- Peters Medical Research
- IPS Research Company, INC.
- DelRicht Research - Grassroots Healthcare
- Coastal Carolina Research Center
- Clinical Neuroscience Solutions, Inc.
- Austin Clinical Trial Partners
- Charlottesville Medical Research, LLC
- Clinical Investigation Specialists, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
TNX-1900 High Dose
TNX-1900 Low Dose
Placebo
Arm Description
30 IU oxytocin taken intranasally twice daily.
30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily.
Placebo taken intranasally twice daily.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05679908
First Posted
December 19, 2022
Last Updated
October 3, 2023
Sponsor
Tonix Pharmaceuticals, Inc.
Collaborators
Premier
1. Study Identification
Unique Protocol Identification Number
NCT05679908
Brief Title
A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tonix Pharmaceuticals, Inc.
Collaborators
Premier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine, Chronic Migraine, Headache, Chronic Migraine Without Aura, Aura Migraine
Keywords
Migraine, Chronic Migraine, Headache, Chronic Migraine Without Aura, Aura Migraine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TNX-1900 High Dose
Arm Type
Experimental
Arm Description
30 IU oxytocin taken intranasally twice daily.
Arm Title
TNX-1900 Low Dose
Arm Type
Experimental
Arm Description
30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo taken intranasally twice daily.
Intervention Type
Drug
Intervention Name(s)
TNX-1900
Other Intervention Name(s)
intranasal oxytocin
Intervention Description
Patients will spray TNX-1900 once into each nostril.
Intervention Type
Drug
Intervention Name(s)
Placebo Nasal Spray
Intervention Description
Patients will spray placebo nasal spray once into each nostril.
Primary Outcome Measure Information:
Title
Mean change in the number of monthly migraine headache days
Description
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.
Time Frame
Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)
Secondary Outcome Measure Information:
Title
Proportion of patients experiencing a ≥ 50% reduction in the number of migraine headache days
Description
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
Time Frame
Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)
Title
Mean change in the number of days using rescue medication
Description
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.
Time Frame
Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12)
Title
Patient Global Impression of Change (PGIC)
Description
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.
Time Frame
Visit 5 (Week 12)
Title
Mean change in the number of moderate or severe headache days
Description
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.
Time Frame
Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12)
Title
Mean change in the number of migraine headache days
Description
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.
Time Frame
Last 28 days before Visit 2 (Day 1) and average per 28 days over 12-week Treatment Period
Title
Mean change from Baseline in the Migraine-Specific Quality of Life Questionnaire
Description
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.
Time Frame
Visit 2 (Day 1) and Visit 5 (Week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Sullivan, MD
Organizational Affiliation
Tonix Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Preferred Research Partners, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Synergy Research Centers - Synergy San Diego
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Viking Clinical Research, LTD
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Segal Trials - Miami Lakes Medical Research Outpatient Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Diamond Headache Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60642
Country
United States
Facility Name
Integrated Clinical Trial Services, Inc.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Alliance for Multispecialty Research - Wichita West
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
DelRicht Research - LCMC Health Urgent Care
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
DelRicht Research - Neighborhood Health
City
Prairieville
State/Province
Louisiana
ZIP/Postal Code
70769
Country
United States
Facility Name
Boston Clinical Trials, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Michigan Headache & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
DelRicht Research - Gulfport Memorial
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39501
Country
United States
Facility Name
Clinvest Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Alliance for Multispecialty Research - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Upstate Clinical Research Associates, LLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27260
Country
United States
Facility Name
IPS Research Company, INC.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
DelRicht Research - Grassroots Healthcare
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Austin Clinical Trial Partners
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Charlottesville Medical Research, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Clinical Investigation Specialists, Inc.
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine
We'll reach out to this number within 24 hrs