A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia (RESILIENT)

Tonix Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: Placebo SL Tablet; Drug: TNX-102 SL Tablet, 5.6 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05273749

TNX-CY-F307

Details and patient eligibility

About

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.

Enrollment: 457 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Exclusion criteria

• The patient has been diagnosed with infectious or inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (ie, any acute attacks within past 2 years is exclusionary), or meets criteria for other type of systemic autoimmune disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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457 participants in 2 patient groups, including a placebo group

TNX-102 SL Tablet, 5.6 mg

Experimental group

Description:

1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.

Treatment:

Drug: TNX-102 SL Tablet, 5.6 mg

Placebo SL Tablet

Placebo Comparator group

Description:

1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.

Treatment:

Drug: Placebo SL Tablet