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

Completed · Phase 3

Conditions studied: Primary Fibromyalgia

In brief

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.

Key facts

Study ID

NCT02015234

Run by

Tonix Pharmaceuticals, Inc.

People needed

158

Starts

2013-12-01

Expected to finish

2015-08-01

Last updated by the study team

2017-07-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient met all prior inclusion and exclusion requirements for Study F202 (NCT01903265) originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to TNX-102 SL or enrollment in the extension study.
• The patient completed expected dosing in F202 (NCT01903265) defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on responses from daily IVRS calls recorded during the F202 study (NCT01903265)) and no major protocol violations.
• The patient has provided written informed consent to participate in this extension protocol.

You may not qualify if…

• None

Where it is running

• Denver — Denver, Colorado, United States
• 16176 Cortez Boulevard — Brooksville, Florida, United States
• 100 West Gore Street — Orlando, Florida, United States
• 71 Thomas Johnson Drive — Frederick, Maryland, United States
• 370 Faunce Corner Road — North Dartmouth, Massachusetts, United States
• Worcester — Worcester, Massachusetts, United States
• Jackson — Jackson, Mississippi, United States
• Cincinnati — Cincinnati, Ohio, United States
• 1275 Olentangy River Road — Columbus, Ohio, United States
• 18660 Bagley Road — Middleburg Heights, Ohio, United States
• 1001 South Market Street — Mechanicsburg, Pennsylvania, United States
• 322 Memorial Drive — Greer, South Carolina, United States
• 601 Broadway — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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