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Completed Phase 3 Interventional Results available

A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

ClinicalTrials.gov ID: NCT04508621

Public ClinicalTrials.gov record NCT04508621. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 6:03 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04508621
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Enrollment
514 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 22, 2020 (Actual)
Primary completion
Nov 1, 2021 (Actual)
Completion
Nov 1, 2021 (Actual)
Last update posted
Dec 18, 2023

2020 – 2021

United States locations

U.S. sites
36
U.S. states
23
U.S. cities
36
Facility City State ZIP Site status
Tonix Clinical Site Birmingham Alabama 35216 —
Tonix Clinical Site Phoenix Arizona 85016 —
Tonix Clinical Site Oceanside California 92056 —
Tonix Clinical Site San Diego California 92103 —
Tonix Clinical Site Santa Ana California 92705 —
Tonix Clinical Site Temecula California 32591 —
Tonix Clinical Site Cromwell Connecticut 06416 —
Tonix Clinical Site Fort Myers Florida 33912 —
Tonix Clinical Site Jacksonville Florida 32256 —
Tonix Clinical Site North Miami Florida 33161 —
Tonix Clinical Site Ocala Florida 34470 —
Tonix Clinical Site Orlando Florida 32801 —
Tonix Clinical Site Alpharetta Georgia 30022 —
Tonix Clinical Site Evansville Indiana 47714 —
Tonix Clinical Site West Des Moines Iowa 50265 —
Tonix Clinical Site Prairie Village Kansas 66208 —
Tonix Clinical Site New Orleans Louisiana 70115 —
Tonix Clinical Site Boston Massachusetts 02131 —
Tonix Clinical Site Albuquerque New Mexico 87109 —
Tonix Clinical Site Williamsville New York 14221 —
Tonix Clinical Site High Point North Carolina 27262 —
Tonix Clinical Site Raleigh North Carolina 27612 —
Tonix Clinical Site Cincinnati Ohio 45219 —
Tonix Clinical Site Dayton Ohio 45417 —
Tonix Clinical Site North Canton Ohio 44720 —
Tonix Clinical Site Oklahoma City Oklahoma 73112 —
Tonix Clinical Site Tulsa Oklahoma 74133 —
Tonix Clinical Site Portland Oregon 97210 —
Tonix Clinical Site Warwick Rhode Island 02886 —
Tonix Clinical Site Chattanooga Tennessee 37421 —
Tonix Clinical Site Memphis Tennessee 38119 —
Tonix Clinical Site Austin Texas 78737 —
Tonix Clinical Site Dallas Texas 75231 —
Tonix Clinical Site Salt Lake City Utah 84102 —
Tonix Clinical Site Charlottesville Virginia 22911 —
Tonix Clinical Site Kenosha Wisconsin 53144 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04508621, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 18, 2023 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04508621 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →