Status:
TERMINATED
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD
Lead Sponsor:
Tonix Pharmaceuticals, Inc.
Conditions:
PTSD
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 fo...
Eligibility Criteria
Inclusion
- 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
- Use of antidepressant medication within 2 months of Baseline
Key Trial Info
Start Date :
March 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2020
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT03841773
Start Date
March 7 2019
End Date
April 24 2020
Last Update
February 6 2025
Active Locations (30)
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1
Ashild Peters
Phoenix, Arizona, United States, 85012
2
Ashild Peters
Little Rock, Arkansas, United States, 72211
3
Ashild Peters
Rogers, Arkansas, United States, 72758
4
Ashild Peters
Beverly Hills, California, United States, 90210