Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions (AtEase)

Tonix Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: PTSD

Treatments: Drug: Placebo; Drug: TNX-102 SL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02277704

TNX-CY-P201

Details and patient eligibility

About

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL -a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible subjects will return regularly to the study clinic for weekly or biweekly visits for assessments of efficacy and safety.

Enrollment: 245 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female between 18 and 65 years of age
• Diagnosed with current PTSD as defined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5),
• For patients with a qualifying Index trauma(s) resulting in PTSD that occurred during military service, military contractor, Department of Homeland Security or law enforcement
• Willing and able to withdraw and refrain from specific therapies (ask PI)
• Use medically acceptable form of contraception (female only)
• Signed informed consent

Exclusion criteria

• Significant traumatic brain injury
• Severe depression
• Bipolar and psychotic disorders
• Increase risk of suicide
• Significant clinical (cardiac, systemic infection, drug/alcohol abuse) or laboratory abnormalities (including positivity for Hep B, Hep C, HIV)
• Unable to wash-out specific medications (ask PI)
• History of violent behavior within past 2 years, unrelated to work duties
• History of drug or alcohol abuse within past 6 months
• Positive illegal substance test
• Known hypersensitivity to cyclobenzaprine
• Others: seizure disorders, uncontrolled sleep apnea, BMI>40
• Participation in an investigational study in past 30 days
• In the process of litigating for compensation for a psychiatric disorder
• Females that are pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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245 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.

Treatment:

Drug: Placebo

TNX-102 SL, 2.8 mg

Active Comparator group

Description:

1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.

Treatment:

Drug: TNX-102 SL

Drug: Placebo

TNX-102 SL, 5.6 mg

Active Comparator group

Description:

2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.

Treatment:

Drug: TNX-102 SL