drugset / Trial / NCT04508621

A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

NCT04508621

Phase 3 Completed 514 enrolled Tonix Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.

Timeline

Start
2020-07-22
Primary completion
2021-11-01
Completion
2021-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject cyclobenzaprine Small molecule 5.6 mg Other

Indications