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

Recruitment Status : Terminated (Interim Analysis results)

First Posted : February 15, 2019

Last Update Posted : February 11, 2021

Sponsor:

Information provided by (Responsible Party):

Tonix Pharmaceuticals, Inc.

Study Description

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 Design

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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
Actual Primary Completion Date :	April 24, 2020
Actual Study Completion Date :	April 24, 2020

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: TNX-102 SL Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks Other Names: Low dose cyclobenzaprine sublingual tablets Tonmya(R)
Placebo Comparator: Placebo SL Tablet 2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.	Drug: Placebo SL Tablets Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks Other Names: Placebo sublingual tablets TNX-102 SL Placebo Tablets

Outcome Measures

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 ]

Eligibility Criteria

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

Contacts and Locations

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

Locations

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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

Sponsors and Collaborators

Tonix Pharmaceuticals, Inc.

Investigators

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Study Director:	Gregory M Sullivan, MD	Tonix Pharmaceuticals

More Information

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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 11, 2021
Last Verified:	February 2021

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Tonix Pharmaceuticals, Inc.:


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

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