A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD (RECOVERY)
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03841773 |
Recruitment Status :
Active, not recruiting
First Posted : February 15, 2019
Last Update Posted : February 10, 2020
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Condition or disease | Intervention/treatment | Phase |
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PTSD | Drug: TNX-102 SL Drug: Placebo SL Tablets | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 192 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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- 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 ]
- Change from baseline in CGI-S score. [ Time Frame: Week 0, Week 4, Week 8 and Week 12 ]

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 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Arizona | |
Ashild Peters | |
Phoenix, Arizona, United States, 85012 | |
United States, Arkansas | |
Ashild Peters | |
Little Rock, Arkansas, United States, 72211 | |
Ashild Peters | |
Rogers, Arkansas, United States, 72758 | |
United States, California | |
Ashild Peters | |
Beverly Hills, California, United States, 90210 | |
Ashild Peters | |
Oceanside, California, United States, 92056 | |
Ashild Peters | |
Orange, California, United States, 92868 | |
Ashild Peters | |
Panorama City, California, United States, 91402 | |
Ashild Peters | |
Riverside, California, United States, 92506 | |
Ashild Peters | |
San Diego, California, United States, 92123 | |
Ashild Peters | |
Temecula, California, United States, 92591 | |
United States, Colorado | |
Ashild Peters | |
Colorado Springs, Colorado, United States, 80910 | |
United States, Connecticut | |
Ashild Peters | |
Norwich, Connecticut, United States, 06360 | |
United States, District of Columbia | |
Ashild Peters | |
Washington, District of Columbia, United States, 20011 | |
United States, Florida | |
Ashild Peters | |
Jacksonville, Florida, United States, 32256 | |
Ashild Peters | |
North Miami, Florida, United States, 33161 | |
Ashild Peters | |
Orlando, Florida, United States, 32801 | |
Ashild Peters | |
Tampa, Florida, United States, 33614 | |
United States, Georgia | |
Ashild Peters | |
Alpharetta, Georgia, United States, 30341 | |
United States, Illinois | |
Ashild Peters | |
Lincolnwood, Illinois, United States, 60712 | |
United States, Massachusetts | |
Ashild Peters | |
Boston, Massachusetts, United States, 02131 | |
Ashild Peters | |
New Bedford, Massachusetts, United States, 02740 | |
United States, Mississippi | |
Ashild Peters | |
Flowood, Mississippi, United States, 39232 | |
United States, Missouri | |
Ashild Peters | |
Saint Louis, Missouri, United States, 63141 | |
United States, Nevada | |
Ashild Peters | |
Las Vegas, Nevada, United States, 89102 | |
United States, Oklahoma | |
Ashild Peters | |
Oklahoma City, Oklahoma, United States, 73106 | |
United States, Oregon | |
Ashild Peters | |
Portland, Oregon, United States, 97214 | |
Ashild Peters | |
Salem, Oregon, United States, 97301 | |
United States, Tennessee | |
Ashild Peters | |
Memphis, Tennessee, United States, 38119 | |
United States, Texas | |
Ashild Peters | |
Austin, Texas, United States, 78737 | |
Ashild Peters | |
Dallas, Texas, United States, 75231 |
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: | February 10, 2020 |
Last Verified: | February 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
PTSD |
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 |