A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients

Primary Fibromyalgia Clinical Trial

Official title: A 3-Month, Multicenter, Open-Label Extension to Evaluate Safety and Efficacy of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia

Status Terminated

Clinical Trial Summary

This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302. Anticipated start for TNX-CY-F302 is for March 2016.

Patients will not be made aware of the therapy they received during the double-blind study.

Clinical Trial Description

The study consist of 4 study visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same date as Visit 6 in F301 or F302) and visits after 1, 2 and 3 months of treatment (Visits 2-4).

Primary:

The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 3 months in patients with FM who have completed the double-blinded lead-in study

Secondary:

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Primary Fibromyalgia

• NCT number: NCT02589275
• Study type: Interventional
• Source: Tonix Pharmaceuticals, Inc.
• Status: Terminated
• Phase: Phase 3
• Start date: August 2015
• Completion date: September 2016