drugset / Trial / NCT02589275

A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients

NCT02589275

Phase 3 Completed 375 enrolled Tonix Pharmaceuticals, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302. Patients will not be made aware of the therapy they received during the double-blind study.

Timeline

Start
2015-08-04
Primary completion
2016-09-28
Completion
2016-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject cyclobenzaprine Small molecule 2.8 mg Other

Indications