drugset / Trial / NCT01903265

BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)

NCT01903265

Phase 2/3 Completed 205 enrolled Tonix Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

TNX-102 capsules \[formerly known as very low dose (VLD) cyclobenzaprine\] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.

Timeline

Start
2013-09
Primary completion
2014-07
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject cyclobenzaprine Small molecule 2.8 mg

Indications