Clinical trial NCT05372887: Safety and Efficacy Study of TNX-102 SL in Participants With PTSD
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: PTSD
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from baseline in the total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.
timeFrame: Day 1, Week 4, Week 12
Secondary outcomes:
measure: Clinical Global Impression - Severity change from Baseline to Week 12
timeFrame: Day 1, Week 4, Week 8, Week 12
measure: Change from baseline in the disruption of psychosocial functioning assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment.
timeFrame: Day 1, Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Aga Khan University Clinical Research Unit
city: Nairobi
country: Kenya
facility: Centre for Clinical Research at KEMRI-Nairobi
city: Nairobi
country: Kenya
facility: Moi University Clinical Research Centre
Study officials:
affiliation: Tonix Pharmaceuticals
name: Gregory Sullivan, MD
role: STUDY_DIRECTOR
References: