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

Tonix Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Primary Fibromyalgia

Treatments: Drug: TNX-102 SL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02015234

TNX-CY-F203

Details and patient eligibility

About

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.

Full description

The study consisted of 7 clinic visits, including Screening/Baseline Visit 1 (Day 0 which was typically the same date as Visit 6 of the double-blind lead-in study), 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 was to evaluate the long-term safety of TNX-102 SL tablets taken daily at bedtime over 12 months in patients with fibromyalgia who have completed Study TNX-CY-F202 (NCT01903265)

Secondary:

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

Enrollment: 158 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. 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.
3. The patient has provided written informed consent to participate in this extension protocol.

Exclusion criteria

None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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158 participants in 1 patient group

TNX-102 SL

Experimental group

Description:

1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months

Treatment:

Drug: TNX-102 SL