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

Summary

This was an 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 fibromyalgia. Patients recruited into this trial were those who had successfully completed the double-blind study, TNX-CY-F202 (F202) (NCT01903265). Patients were not made aware of the therapy they received during the double-blind study.

Timeline

Start

2013-12

Primary completion

2015-08

Completion

2015-08

Drugs

Indications