Safety and Efficacy Study of TNX-102 SL in Participants With PTSD

A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Daily Bedtime TNX-102 SL in Participants With PTSD

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.

Study Overview

• Status: Withdrawn
• Conditions: PTSD
• Intervention / Treatment: Drug: TNX-102 SL; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ashild Peters; Phone Number: +1 619-991-0553; Email: ashild.peters@tonixpharma.com

Study Locations

• Kenya
  • Nairobi, Kenya
    • Aga Khan University Clinical Research Unit
  • Nairobi, Kenya
    • Centre for Clinical Research at KEMRI-Nairobi
  • Nairobi, Kenya
    • Moi University Clinical Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female between 18 and 75 years of age, at the time of signing ICF, inclusive.
• Diagnosed with current (past month) PTSD as determined by the MINI 7.0.2 Module H (PTSD).
• Index trauma(s) resulting in PTSD must meet DSM-5 Criterion A for PTSD as described in the CAPS 5, must have occurred within 9 years of Screening Visit 1, and must have occurred when the participant was ≥18 years of age.
• Willing and able to withdraw and refrain from opioids for the course of the study.
• Willing to refrain from use of all other formulations of cyclobenzaprine for the course of the study.
• Willing and able to refrain from antidepressants and other excluded medications.
• Capable of reading and understanding English and able to provide written informed consent to participate.
• Willing to comply with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
• If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.
• Body mass index (BMI) within the range 17.5 - 35 kg/m^2 (inclusive).

Exclusion Criteria:

• Current or ongoing exposure to the trauma that resulted in the PTSD (ie, non-work-related trauma such as ongoing domestic abuse).
• 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 (eg, 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 participants who are pregnant or lactating.
• History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients in TNX-102 SL or placebo formulations.
• Seizure disorder.
• Current moderate or severe sleep apnea not well controlled by positive airway pressure (PAP) or oral (mouthpiece) devices.
• Has received any other investigational drug within 90 days before Screening or has taken cyclobenzaprine within 21 days of the Randomization visit.
• Previous participation in any other study with TNX-102 SL.
• Family member of investigative staff.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TNX-102 SL, 5.6 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 each day at bedtime starting on Day 1 for 12 weeks; Other Names: Low dose cyclobenzaprine sublingual tablets
Placebo Comparator: Placebo; 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.	Drug: Placebo; Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks; Other Names: Placebo sublingual tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, fifth edition (CAPS-5) total symptom severity score in a 12-week study.	Day 1, Week 4, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression - Severity change from Baseline to Week 12	CGI-S to assess global severity change from baseline to Week 12	Day 1, Week 4, Week 8, Week 12
Change from baseline in the disruption of psychosocial functioning assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment.	SDS to assess psychosocial functioning change from baseline to Week 12	Day 1, Week 4, Week 8, Week 12

Collaborators and Investigators

• Sponsor: Tonix Pharmaceuticals, Inc.
• Investigators: Study Director: Gregory Sullivan, MD, Tonix Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2022
• Primary Completion (Actual): November 8, 2022
• Study Completion (Actual): November 8, 2022

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antidepressive Agents, Tricyclic; Neuromuscular Agents; Muscle Relaxants, Central; Cyclobenzaprine
• Other Study ID Numbers: TNX-CY-P308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No