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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05372887
• Other study ID #: TNX-CY-P308
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 14, 2022
• Est. completion date: November 8, 2022

Study information

• Verified date: December 2023
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 8, 2022
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• PTSD

Intervention

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

Locations

Country	Name	City	State
Kenya	Aga Khan University Clinical Research Unit	Nairobi
Kenya	Centre for Clinical Research at KEMRI-Nairobi	Nairobi
Kenya	Moi University Clinical Research Centre	Nairobi

Sponsors (1)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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