Status:
WITHDRAWN
Safety and Efficacy Study of TNX-102 SL in Participants With PTSD
Lead Sponsor:
Tonix Pharmaceuticals, Inc.
Conditions:
PTSD
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 form...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05372887
Start Date
October 14 2022
End Date
November 8 2022
Last Update
December 11 2023
Active Locations (3)
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1
Aga Khan University Clinical Research Unit
Nairobi, Kenya
2
Centre for Clinical Research at KEMRI-Nairobi
Nairobi, Kenya
3
Moi University Clinical Research Centre
Nairobi, Kenya