NCT03062540Phase 3Terminated

Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD

Study sponsor: Tonix Pharmaceuticals, Inc.

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2018-07-27Actual

Enrollment · participants358Actual

Source updated2024-05-22Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

PTSD

Treatments or interventions studied

TNX-102 SLDrugAlso known as Low dose cyclobenzaprine sublingual tablets
Placebo SL TabletDrugAlso known as Placebo sublingual tablets

Primary outcomes · main study measures

Read the study measures

measure: Mean Change From Baseline in the Total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.; description: To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5) total symptom severity score in a 12-week study. Score ranges from 0 to 80 with lower scores indicating less severe PTSD symptoms.; timeFrame: Day 0 and Week 12

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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