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

Phase 3

Completed

• Conditions: Primary Fibromyalgia
• Interventions: Drug: TNX-102 SL Tablet 2.8 mg

• Registration Number: NCT02589275
• Lead Sponsor: Tonix Pharmaceuticals, Inc.

Brief 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.

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

Detailed Description

The study consist of 4 study visits, including Screening/Baseline Visit 1 (Day 1, 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

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-28
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Disposition First Submitted: 2018-04-23
• Disposition First Submitted QC: 2018-04-23
• Disposition First Posted: 2018-04-25
• Status Verified: 2024-11
• Results First Submitted: 2024-11-18
• Results First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Results First Posted: 2024-12-11
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

• The patient met all prior inclusion and exclusion requirements for study F301 or F302 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 F301 or F302 defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on overall drug accountability reconciliation at the end of the F301 or F302 lead-in study) and no major protocol deviations.
• The patient has provided written informed consent to participate in this extension protocol.

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TNX-102 SL Tablet 2.8 mg	TNX-102 SL Tablet 2.8 mg	1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 3 months

Primary Outcome Measures

Name	Time	Method
Newly Emergent Adverse Events	Up to 3 months from first dose	The number of patients with at least one adverse event which began after the first dose of TNX-102 SL in this open-label extension study.