Conditions: PTSD
Keywords: PTSD Military-related PTSD and other related conditions
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 245
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. arm 2: 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. arm 3: 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.

Interventions: intervention 1: TNX-102 SL intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: