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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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)

    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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05273749
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Tonix Pharmaceuticals, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gregory Sullivan, MD
Principal Investigator Affiliation Tonix Pharmaceuticals, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Fibromyalgia
Arms & Interventions

Arms

Experimental: TNX-102 SL Tablet, 2.8 mg

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.

Placebo Comparator: Placebo SL Tablet

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.

Interventions

Drug: - 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 patients will have the dose increased to 2 tablets for 12 weeks.

Drug: - 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 patients will have the dose increased to 2 tablets for 12 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tonix Clinical Site, Phoenix, Arizona

Status

Not yet recruiting

Address

Tonix Clinical Site

Phoenix, Arizona, 85012

Tonix Clinical Site, Oceanside, California

Status

Recruiting

Address

Tonix Clinical Site

Oceanside, California, 92056

Tonix Clinical Site, San Diego, California

Status

Recruiting

Address

Tonix Clinical Site

San Diego, California, 92103

Tonix Clinical Site, Santa Ana, California

Status

Recruiting

Address

Tonix Clinical Site

Santa Ana, California, 92705

Tonix Clinical Site, Temecula, California

Status

Recruiting

Address

Tonix Clinical Site

Temecula, California, 92591

Tonix Clinical Site, Cromwell, Connecticut

Status

Not yet recruiting

Address

Tonix Clinical Site

Cromwell, Connecticut, 06416

Tonix Clinical Site, Fort Myers, Florida

Status

Recruiting

Address

Tonix Clinical Site

Fort Myers, Florida, 33912

Tonix Clinical Site, Jacksonville, Florida

Status

Recruiting

Address

Tonix Clinical Site

Jacksonville, Florida, 32256

Tonix Clinical Site, Miami Lakes, Florida

Status

Recruiting

Address

Tonix Clinical Site

Miami Lakes, Florida, 33016

Tonix Clinical Site, Ocala, Florida

Status

Recruiting

Address

Tonix Clinical Site

Ocala, Florida, 34470

Tonix Clinical Site, Orlando, Florida

Status

Recruiting

Address

Tonix Clinical Site

Orlando, Florida, 32801

Tonix Clinical Site, Sarasota, Florida

Status

Recruiting

Address

Tonix Clinical Site

Sarasota, Florida, 34243

Tonix Clinical Site, Alpharetta, Georgia

Status

Not yet recruiting

Address

Tonix Clinical Site

Alpharetta, Georgia, 30022

Tonix Clinical Site, Atlanta, Georgia

Status

Recruiting

Address

Tonix Clinical Site

Atlanta, Georgia, 30329

Tonix Clinical Site, Evansville, Indiana

Status

Recruiting

Address

Tonix Clinical Site

Evansville, Indiana, 47714

Tonix Clinical Site, West Des Moines, Iowa

Status

Recruiting

Address

Tonix Clinical Site

West Des Moines, Iowa, 50265

Tonix Clinical Site, Prairie Village, Kansas

Status

Recruiting

Address

Tonix Clinical Site

Prairie Village, Kansas, 66208

Tonix Clinical Site, New Orleans, Louisiana

Status

Recruiting

Address

Tonix Clinical Site

New Orleans, Louisiana, 70115

Tonix Clinical Site, Prairieville, Louisiana

Status

Recruiting

Address

Tonix Clinical Site

Prairieville, Louisiana, 70769

Tonix Clinical Site, Boston, Massachusetts

Status

Not yet recruiting

Address

Tonix Clinical Site

Boston, Massachusetts, 02131

Tonix Clinical Site, Gulfport, Mississippi

Status

Recruiting

Address

Tonix Clinical Site

Gulfport, Mississippi, 39501

Tonix Clinical Site, Albuquerque, New Mexico

Status

Recruiting

Address

Tonix Clinical Site

Albuquerque, New Mexico, 87109

Tonix Clinical Site, Williamsville, New York

Status

Recruiting

Address

Tonix Clinical Site

Williamsville, New York, 14221

Tonix Clinical Site, Cincinnati, Ohio

Status

Not yet recruiting

Address

Tonix Clinical Site

Cincinnati, Ohio, 45219

Tonix Clinical Site, Tulsa, Oklahoma

Status

Recruiting

Address

Tonix Clinical Site

Tulsa, Oklahoma, 74133

Tonix Clinical Site, Portland, Oregon

Status

Recruiting

Address

Tonix Clinical Site

Portland, Oregon, 97210

Tonix Clinical Site, Austin, Texas

Status

Recruiting

Address

Tonix Clinical Site

Austin, Texas, 78737

Tonix Clinical Site, Dallas, Texas

Status

Recruiting

Address

Tonix Clinical Site

Dallas, Texas, 75231

Tonix Clinical Site, Charlottesville, Virginia

Status

Recruiting

Address

Tonix Clinical Site

Charlottesville, Virginia, 22911

Tonix Clinical Site, Kenosha, Wisconsin

Status

Recruiting

Address

Tonix Clinical Site

Kenosha, Wisconsin, 53144