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

Primary Fibromyalgia Clinical Trial

Official title:
A Phase 2b, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken at Bedtime in Patients With Fibromyalgia

Status Completed

Clinical Trial Summary

TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime has shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial is 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01903265
Study type	Interventional
Source	Tonix Pharmaceuticals, Inc.
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	September 2013
Completion date	November 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03783910` - Efficacy and Safety of GRT9906 Tablets Compared to Placebo in Patients With Fibromyalgia	Phase 2
Completed	`NCT02015234` - 12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients	Phase 3
Terminated	`NCT02589275` - A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients	Phase 3
Terminated	`NCT01328002` - Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia	Phase 2
Completed	`NCT01820052` - A Randomized Trial of Oral Iron Therapy in Fibromyalgia	Phase 3
Terminated	`NCT01331109` - Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia	Phase 2