A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

• Status: Active, not recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tonix Pharmaceuticals, Inc.
• Treatments: Cyclobenzaprine

Criteria

Inclusion Criteria:

• The patient is male or female 18 to 65 years of age, inclusive.

• The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)

• The in clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol defined range.

Exclusion Criteria:

• History of or evidence for a diagnosis of borderline personality disorder (BPD).