Trial record 1 of 1 for:
NCT05679908
A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine (PREVENTION)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05679908 |
|
Recruitment Status :
Recruiting
First Posted : January 11, 2023
Last Update Posted : January 11, 2023
|
Sponsor:
Tonix Pharmaceuticals, Inc.
Collaborator:
Premier
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Migraine Chronic Migraine, Headache Chronic Migraine Without Aura Aura Migraine | Drug: TNX-1900 Drug: Placebo Nasal Spray | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | 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) |
| Actual Study Start Date : | December 6, 2022 |
| Estimated Primary Completion Date : | March 2024 |
| Estimated Study Completion Date : | March 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Sporadic hemiplegic migraine
Migraine
Familial hemiplegic migraine
Drug Information available for:
Oxytocin
| Arm | Intervention/treatment |
|---|---|
|
Experimental: TNX-1900 High Dose
30 IU oxytocin taken intranasally twice daily.
|
Drug: TNX-1900
Patients will spray TNX-1900 once into each nostril.
Other Name: intranasal oxytocin |
|
Experimental: TNX-1900 Low Dose
30 IU oxytocin taken intranasally once daily. Placebo taken intranasally once daily.
|
Drug: TNX-1900
Patients will spray TNX-1900 once into each nostril.
Other Name: intranasal oxytocin Drug: Placebo Nasal Spray Patients will spray placebo nasal spray once into each nostril. |
|
Placebo Comparator: Placebo
Placebo taken intranasally twice daily.
|
Drug: Placebo Nasal Spray
Patients will spray placebo nasal spray once into each nostril. |
Primary Outcome Measures :
- Mean change in the number of monthly migraine headache days [ Time Frame: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12) ]
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 [ Time Frame: Last 28 days before Visit 2 (Day 1) treatment and last 28 days before Visit 5 (Week 12) ]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 [ Time Frame: 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 (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) [ Time Frame: Visit 5 (Week 12) ]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 [ Time Frame: Last 28 days before Visit 2 (Day 1) and last 28 days before Visit 5 (Week 12) ]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 [ Time Frame: Last 28 days before Visit 2 (Day 1) and average per 28 days over 12-week Treatment Period ]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 [ Time Frame: Visit 2 (Day 1) and Visit 5 (Week 12) ]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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05679908
Contacts
| Contact: Clinical Program Manager | 212-980-9155 | shazia.khan@tonixpharma.com | |
| Contact: Clinical Trial Associate | timothy.roush@tonixpharma.com |
Locations
Show 24 study locations
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Premier
Investigators
| Study Director: | Gregory Sullivan, MD | Tonix Pharmaceuticals |
| Responsible Party: | Tonix Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT05679908 |
| Other Study ID Numbers: |
TNX-CY-CM201 |
| First Posted: | January 11, 2023 Key Record Dates |
| Last Update Posted: | January 11, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Tonix Pharmaceuticals, Inc.:
|
Migraine Chronic Migraine Headache Chronic Migraine Without Aura Aura Migraine |
Additional relevant MeSH terms:
|
Migraine Disorders Migraine without Aura Migraine with Aura Headache Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Pain Neurologic Manifestations Oxytocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs |