Overview

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

Status:
Completed
Trial end date:
2020-10-29
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 specified range.

Exclusion Criteria:

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