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

NCT05372887 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: TNX-CY-P308
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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

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, fifth edition (CAPS-5) total symptom severity score in a 12-week study.

  Day 1, Week 4, Week 12

Secondary Outcomes (2)

• Clinical Global Impression - 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.

  Day 1, Week 4, Week 8, Week 12

Study Arms (2)

TNX-102 SL, 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

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

TNX-102 SL DRUG

Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks

Also known as: Low dose cyclobenzaprine sublingual tablets

TNX-102 SL, 5.6 mg

Placebo DRUG

Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks

Also known as: Placebo sublingual tablets

Placebo

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, 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead

Study Sites (3)

Aga Khan University Clinical Research Unit

Nairobi, Kenya

Location

Centre for Clinical Research at KEMRI-Nairobi

Nairobi, Kenya

Location

Moi University Clinical Research Centre

Nairobi, Kenya

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Gregory Sullivan, MD

  Tonix Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: May 9, 2022
• First Posted: May 13, 2022
• Study Start: October 14, 2022
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

KE (3)