Trial record 1 of 1 for:
NCT03841773
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD (RECOVERY)
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| ClinicalTrials.gov Identifier: NCT03841773 |
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Recruitment Status :
Recruiting
First Posted : February 15, 2019
Last Update Posted : April 19, 2019
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Sponsor:
Tonix Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.
- Study Details
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Brief Summary:
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) - a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| PTSD | Drug: TNX-102 SL Drug: Placebo SL Tablets | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 250 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302) |
| Actual Study Start Date : | March 7, 2019 |
| Estimated Primary Completion Date : | March 15, 2020 |
| Estimated Study Completion Date : | March 15, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: TNX-102 SL Tablet 2.8 mg
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
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Drug: TNX-102 SL
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
Other Names:
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Placebo Comparator: Placebo SL Tablet
2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
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Drug: Placebo SL Tablets
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
Other Names:
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Primary Outcome Measures :
- The mean change from baseline (Visit 2) in the Total CAPS-5 score evaluated at the landmark visit. [ Time Frame: Week 0, Week 4, Week 8 and Week 12 ]
Secondary Outcome Measures :
- Change from baseline in CGI-S score. [ Time Frame: Week 0, Week 4, Week 8 and Week 12 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening)
- Index trauma must have occurred within 9 years of Screening Visit
- Must have occurred when the patient was ≥18 years of age
Exclusion Criteria:
- Use of antidepressant medication within 2 months of Baseline
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): NCT03841773
Contacts
| Contact: Ashild Peters | 858-333-5635 | ashild.peters@tonixpharma.com |
Locations
| United States, Arizona | |
| Ashild Peters | Recruiting |
| Phoenix, Arizona, United States, 85012 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, Arkansas | |
| Ashild Peters | Recruiting |
| Little Rock, Arkansas, United States, 72211 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| Ashild Peters | Recruiting |
| Rogers, Arkansas, United States, 72758 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, California | |
| Ashild Peters | Recruiting |
| Beverly Hills, California, United States, 90210 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| Ashild Peters | Recruiting |
| Oceanside, California, United States, 92056 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| Ashild Peters | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| Ashild Peters | Recruiting |
| Panorama City, California, United States, 91402 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| Ashild Peters | Not yet recruiting |
| Riverside, California, United States, 92506 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| Ashild Peters | Not yet recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| Ashild Peters | Recruiting |
| Temecula, California, United States, 92591 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, Colorado | |
| Ashild Peters | Recruiting |
| Colorado Springs, Colorado, United States, 80910 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, Connecticut | |
| Ashild Peters | Recruiting |
| Norwich, Connecticut, United States, 06360 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, District of Columbia | |
| Ashild Peters | Recruiting |
| Washington, District of Columbia, United States, 20011 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, Florida | |
| Ashild Peters | Recruiting |
| Jacksonville, Florida, United States, 32256 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| Ashild Peters | Recruiting |
| North Miami, Florida, United States, 33161 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| Ashild Peters | Recruiting |
| Orlando, Florida, United States, 32801 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| Ashild Peters | Recruiting |
| Tampa, Florida, United States, 33614 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, Georgia | |
| Ashild Peters | Recruiting |
| Alpharetta, Georgia, United States, 30341 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, Illinois | |
| Ashild Peters | Recruiting |
| Lincolnwood, Illinois, United States, 60712 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, Massachusetts | |
| Ashild Peters | Recruiting |
| Boston, Massachusetts, United States, 02131 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| Ashild Peters | Recruiting |
| New Bedford, Massachusetts, United States, 02740 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, Mississippi | |
| Ashild Peters | Recruiting |
| Flowood, Mississippi, United States, 39232 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, Missouri | |
| Ashild Peters | Recruiting |
| Saint Louis, Missouri, United States, 63141 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, Nevada | |
| Ashild Peters | Recruiting |
| Las Vegas, Nevada, United States, 89102 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, Oklahoma | |
| Ashild Peters | Recruiting |
| Oklahoma City, Oklahoma, United States, 73106 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, Oregon | |
| Ashild Peters | Not yet recruiting |
| Portland, Oregon, United States, 97214 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| Ashild Peters | Not yet recruiting |
| Salem, Oregon, United States, 97301 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, Tennessee | |
| Ashild Peters | Recruiting |
| Memphis, Tennessee, United States, 38119 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| United States, Texas | |
| Ashild Peters | Recruiting |
| Austin, Texas, United States, 78737 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
| Ashild Peters | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Contact: Ashild Peters 858-333-5635 ashild.peters@tonixpharma.com | |
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Investigators
| Study Director: | Gregory M Sullivan, MD | Tonix Pharmaceuticals |
| Responsible Party: | Tonix Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT03841773 |
| Other Study ID Numbers: |
TNX-CY-P302 |
| First Posted: | February 15, 2019 Key Record Dates |
| Last Update Posted: | April 19, 2019 |
| Last Verified: | April 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Tonix Pharmaceuticals, Inc.:
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PTSD |
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Mental Disorders Cyclobenzaprine Antidepressive Agents, Tricyclic Antidepressive Agents |
Psychotropic Drugs Muscle Relaxants, Central Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents Tranquilizing Agents Central Nervous System Depressants |