Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions

Completed · Phase 2

Conditions studied: PTSD

In brief

This is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition. Patients recruited into this trial are those who have successfully completed the double-blind study, TNX-CY-P201 (AtEase Study) \[NCT02277704\]. Patients will not be made aware of the therapy they received during the double-blind study.

Key facts

Study ID

NCT02421679

Run by

Tonix Pharmaceuticals, Inc.

People needed

159

Starts

2015-04-14

Expected to finish

2016-05-26

Last updated by the study team

2025-02-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed the lead-in study and is judged as reasonably compliant, with at least 60% compliance
• Signed informed consent
• Met all prior inclusion and exclusion requirements for lead-in study
• No new or worsening medical conditions since starting the lead-in study that could pose a safety risk or interfere with participation in the study
• Willing to refrain from use of specific medication (ask PI)
• Female patients of childbearing potential continue to practice medically acceptable methods of birth control

You may not qualify if…

• None

Where it is running

• Tuscaloosa VA Medical Center — Tuscaloosa, Alabama, United States
• Noesis Pharma — Phoenix, Arizona, United States
• Sun Valley Research Center — Imperial, California, United States
• Synergy Clinical Research — National City, California, United States
• Excell Research, Inc — Oceanside, California, United States
• Neuropsychiatric Research Center of Orange County — Orange, California, United States
• CITRIALS — Riverside, California, United States
• CESAMH — San Diego, California, United States
• Cns, Inc. — Torrance, California, United States
• Sarkis Clinical Trials — Lake City, Florida, United States
• Compass Research North, LLC — Leesburg, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Atlanta Center For Medical Research — Atlanta, Georgia, United States
• Great Lakes Clinical Trials — Chicago, Illinois, United States
• Novex Clinical Research — New Bedford, Massachusetts, United States
• Premier Psychiatric Research Institute, Inc. — Lincoln, Nebraska, United States
• Altea Research — Las Vegas, Nevada, United States
• Neurobehavioral Research, Inc. — Cedarhurst, New York, United States
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Clinical Trials of Texas — San Antonio, Texas, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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