drugset / Trial / NCT01903265
BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | cyclobenzaprine | Small molecule | 2.8 mg | — |