Clinical trial

A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia

Name

TNX-CY-F306

Description

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.

Trial arms

Trial start

2020-07-22

Estimated PCD

2021-11-01

Trial end

2021-11-01

Status

Completed

Phase

Early phase I

Treatment

TNX-102 SL

Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.

Arms:

TNX-102 SL Tablet, 5.6 mg

Other names:

Low dose cyclobenzaprine sublingual tablets

Placebo SL Tablet

Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.

Arms:

Placebo SL Tablet

Other names:

Placebo sublingual tablets

Size

514

Primary endpoint

Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.

14 weeks

Eligibility 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).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 514, 'type': 'ACTUAL'}}

Updated at

2023-12-18

1 organization

3 products

1 indication

Organization

Tonix Pharmaceuticals

Product

Indication

Product

Product