12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients — BESTFIT-OLE  

Primary Fibromyalgia Clinical Trial

Official title: A 12-Month, Multicenter, Open-Label Extension Study (F202) to Evaluate the Long-term Safety of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia

Status Completed

Clinical Trial Summary

This is a Phase 3, open-label, extension trial designed to evaluate the long-term safety over 12 months of TNX-102 SL tablets taken daily at bedtime for the treatment of FM. Patients recruited into this trial are those who have successfully completed the double-blind study, TNX-CY-F202 (F202). Patients will not be made aware of the therapy they received during the double-blind study.

Clinical Trial Description

The study will consist of 7 clinic visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same date as Visit 6 in F202), visits after 1, 3, 6, 9, and 12 months of treatment (Visits 2-6), and a Follow-up Visit (Visit 7) scheduled within one month after stopping study drug treatment.

Primary:

The primary objective of the study is to evaluate the long-term safety of TNX-102 SL tablets taken daily at bedtime over 12 months in patients with FM who have completed Study TNX-CY-F202

Secondary:

The secondary objective is to evaluate the long-term efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of FM ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Primary Fibromyalgia

• NCT number: NCT02015234
• Study type: Interventional
• Source: Tonix Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: December 2013
• Completion date: August 2015