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

Tonix Pharmaceuticals logo

Tonix Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Fibromyalgia

Treatments

Drug: Placebo SL Tablet
Drug: TNX-102 SL

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

457 participants in 2 patient groups, including a placebo group

TNX-102 SL Tablet, 2.8 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
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

Trial contacts and locations

33

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Central trial contact

Mary A Kelley, MPH

Data sourced from clinicaltrials.gov

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