A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD (RECOVERY)

Tonix Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: PTSD

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03841773

TNX-CY-P302

Details and patient eligibility

About

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (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.

Enrollment: 192 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening)
• Index trauma must have occurred within 9 years of Screening Visit
• Must have occurred when the patient was ≥18 years of age

Exclusion criteria

• Use of antidepressant medication within 2 months of Baseline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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192 participants in 2 patient groups, including a placebo group

TNX-102 SL Tablet 2.8 mg

Experimental group

Description:

2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.

Treatment:

Drug: TNX-102 SL

Placebo SL Tablet

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo SL Tablets