Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD

NCT03062540 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: TNX-CY-P301
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 44

Brief Summary

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (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.

Conditions

PTSD

Keywords

PTSD; Military-related PTSD

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in the Total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.

  To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5) total symptom severity score in a 12-week study. Score ranges from 0 to 80 with lower scores indicating less severe PTSD symptoms.

  Day 0 and Week 12

Secondary Outcomes (4)

• Clinical Global Impression - Improvement From Initiation of Treatment (CGI-I) Score After 12 Weeks of Treatment.

  Week 12

• Change From Baseline in the Disruption of Social Life/Leisure Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment.

  Day 0, Week 12.

• Change From Baseline in the Disruption of Work/School Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment.

  Day 0, Week 12.

• Change From Baseline in Patients' Quality of Sleep Using the Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance Scale After 12 Weeks of Treatment.

  Day 0, Week 12.

Study Arms (2)

TNX-102 SL Tablet, 5.6 mg

EXPERIMENTAL

2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.

Drug: TNX-102 SL

Placebo SL Tablet

PLACEBO COMPARATOR

2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.

Drug: Placebo SL Tablet

Interventions

TNX-102 SL DRUG

Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks

Also known as: Low dose cyclobenzaprine sublingual tablets

TNX-102 SL Tablet, 5.6 mg

Placebo SL Tablet DRUG

Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks

Also known as: Placebo sublingual tablets

Placebo SL Tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 18 and 75 years of age, who have served in any branch of the military.
• Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale (CAPS-5) for DSM-5.
• Index trauma(s) resulting in PTSD must meet DSM-5 criterion A for PTSD as described in CAPS-5, have occurred in 2001 or later, be military service related.
• Willing to refrain from use of all other formulations of cyclobenzaprine.
• Willing and able to refrain from antidepressants and other excluded medications.
• Capable of reading and understanding English and able to provide written informed consent.
• If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.
• Willing and able to comply with all protocol-specified requirements.

You may not qualify if:

• Increased risk of suicide, based on the investigator's judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol.
• Significant (e.g., moderate or severe) comorbid traumatic brain injury (TBI) by history.
• Severe depressive symptoms at screening or baseline.
• Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion.
• Use of antidepressant medication within 2 months of baseline.
• Female patients who are pregnant or lactating.
• History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients.
• Seizure disorder.
• Patients with a body mass index (BMI) \> 45.
• Has received any other investigational drug within 30 days before Screening.
• Previous participation in any other study with TNX-102 SL.
• Family member of investigative staff.

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead
• Premier Research: collaborator

Study Sites (44)

Phoenix

Phoenix, Arizona, 85032, United States

Location

Little Rock

Little Rock, Arkansas, 72211, United States

Location

Rogers

Rogers, Arkansas, 72758, United States

Location

Beverly hills

Beverly Hills, California, 90210, United States

Location

Glendale

Glendale, California, 91206, United States

Location

Oakland

Oakland, California, 94607, United States

Location

Oceanside

Oceanside, California, 92056, United States

Location

Orange

Orange, California, 92868, United States

Location

Riverside

Riverside, California, 92506, United States

Location

San Diego

San Diego, California, 92123, United States

Location

San Diego

San Diego, California, 92161, United States

Location

Temecula

Temecula, California, 92591, United States

Location

Colorado Springs

Colorado Springs, Colorado, 80910, United States

Location

Cromwell

Cromwell, Connecticut, 06416, United States

Location

Norwich

Norwich, Connecticut, 06360, United States

Location

Washington, D.C.

Washington D.C., District of Columbia, 20018, United States

Location

Jacksonville

Jacksonville, Florida, 32256, United States

Location

Lake City

Lake City, Florida, 32607, United States

Location

Lauderhill

Lauderhill, Florida, 33319, United States

Location

Maitland

Maitland, Florida, 32751, United States

Location

Tampa

Tampa, Florida, 33609, United States

Location

Atlanta

Atlanta, Georgia, 30341, United States

Location

Chicago

Chicago, Illinois, 60640, United States

Location

New Bedford

New Bedford, Massachusetts, 02740, United States

Location

Flowood

Flowood, Mississippi, 39232, United States

Location

St. Louis

St Louis, Missouri, 63141, United States

Location

Missoula

Missoula, Montana, 59812, United States

Location

Las Vegas

Las Vegas, Nevada, 89102, United States

Location

Berlin

Berlin, New Jersey, 08009, United States

Location

Cedarhurst

Cedarhurst, New York, 11516, United States

Location

New York

New York, New York, 10128, United States

Location

Canton

Canton, Ohio, 44718, United States

Location

Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Dayton

Dayton, Ohio, 45417, United States

Location

Oklahoma City

Oklahoma City, Oklahoma, 73103, United States

Location

Downingtown

Downingtown, Pennsylvania, 19335, United States

Location

Media

Media, Pennsylvania, 19063, United States

Location

Charleston

Charleston, South Carolina, 29407, United States

Location

Austin

Austin, Texas, 78754, United States

Location

Dallas

Dallas, Texas, 75231, United States

Location

Houston

Houston, Texas, 77098, United States

Location

San Antonio

San Antonio, Texas, 78229, United States

Location

Salem

Salem, Virginia, 24153, United States

Location

Everett

Everett, Washington, 98201, United States

Location

Related Publications (2)

• Parmenter ME, Lederman S, Weathers FW, Davis LL, Vaughn B, Engels J, Sullivan GM. A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic stress disorder. Psychiatry Res. 2024 Apr;334:115764. doi: 10.1016/j.psychres.2024.115764. Epub 2024 Feb 1.

  PMID: 38350291 RESULT

• Dunlop BW, Rakofsky JJ, Newport DJ, Mletzko-Crowe T, Barone K, Nemeroff CB, Harvey PD. Efficacy of Vortioxetine Monotherapy for Posttraumatic Stress Disorder: A Randomized, Placebo-Controlled Trial. J Clin Psychopharmacol. 2021 Mar-Apr 01;41(2):172-179. doi: 10.1097/JCP.0000000000001363.

  PMID: 33587394 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Gregory Sullivan, MD
• Organization: Tonix Pharmaceuticals

greg.sullivan@tonixpharma.com

(862) 904-0355

Study Officials

• Greg Sullivan, MD

  Tonix Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 23, 2017
• Study Start: March 27, 2017
• Primary Completion: July 27, 2018
• Study Completion: July 27, 2018
• Last Updated: May 22, 2024
• Results First Posted: May 22, 2024

Record last verified: 2024-04

Locations

US (44)