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TNX-102 SL for Fibromyalgia (RESILIENT Trial)

Phase 3
Waitlist Available
Research Sponsored by Tonix Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 14
Awards & highlights

RESILIENT Trial Summary

This trial will study whether TNX-102 SL, taken at bedtime, is an effective and safe treatment for fibromyalgia.

Eligible Conditions
  • Fibromyalgia

RESILIENT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Pain Score
Secondary outcome measures
Fibromyalgia

Side effects data

From 2015 Phase 3 trial • 158 Patients • NCT02015234
13%
Sinusitis
10%
Fatigue
8%
Upper respiratory tract infection
5%
Constipation
5%
Somnolence
5%
Paraesthesia
3%
Glossodynia
1%
Ankle fracture
1%
Intraductal proliferative breast lesion
1%
Anxiety
1%
Hypoaesthesia oral
1%
Brain stem glioma
1%
Abdominal hernia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - TNX-102 SL 2.8 mg
TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg

RESILIENT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TNX-102 SL Tablet, 2.8 mgExperimental Treatment1 Intervention
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.
Group II: Placebo SL TabletPlacebo Group1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
TNX-102 SL
2019
Completed Phase 3
~1660

Find a Location

Who is running the clinical trial?

Tonix Pharmaceuticals, Inc.Lead Sponsor
29 Previous Clinical Trials
4,409 Total Patients Enrolled
7 Trials studying Fibromyalgia
2,325 Patients Enrolled for Fibromyalgia
Gregory Sullivan, MDStudy DirectorTonix Pharmaceuticals, Inc.
7 Previous Clinical Trials
1,297 Total Patients Enrolled
2 Trials studying Fibromyalgia
1,017 Patients Enrolled for Fibromyalgia

Media Library

Placebo SL Tablet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05273749 — Phase 3
Fibromyalgia Research Study Groups: TNX-102 SL Tablet, 2.8 mg, Placebo SL Tablet
Fibromyalgia Clinical Trial 2023: Placebo SL Tablet Highlights & Side Effects. Trial Name: NCT05273749 — Phase 3
Placebo SL Tablet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05273749 — Phase 3
Fibromyalgia Patient Testimony for trial: Trial Name: NCT05273749 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals outside of the target age group still being included in this research project?

"This research project only allows for volunteers that are between 18-65 years old."

Answered by AI

Could you tell me how many places are handling this clinical trial?

"There are 32 medical facilities participating in this study, with locations spanning from Oldsmar to Temecula to Portland. If you choose to participate in this trial, it is advised that you select a site close to your home to reduce travel costs and time commitment."

Answered by AI

Has the TNX-102 SL drug been given clearance by the FDA?

"There is some evidence to suggest TNX-102 SL's efficacy, and it has been through multiple rounds of testing, so it received a score of 3 for safety."

Answered by AI

Am I a eligible candidate for this clinical trial?

"Currently, this study is looking for 470 individuals who have fibromyalgia and fit the age criteria of being between 18-65 years old. Most importantly, applicants should meet the following requirements: They are either male or female, aged between 18 to 65 years old inclusive, and have 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)."

Answered by AI

Who else is applying?

What state do they live in?
New York
Washington
Nebraska
Other
How old are they?
18 - 65
What site did they apply to?
Tonix Clinical Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+

Why did patients apply to this trial?

interested in trying new ways to help. I have just tried anti-inflammatory drugs.
PatientReceived 1 prior treatment
Chronic pain that is not relieved by muscle relaxers, NSAIDS, tylenol or opioids(tramadol).
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Phone Call
Email
Most responsive sites:
  1. Tonix Clinical Site: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia
2022. "A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05273749.
All > Fibromyalgia
~152 spots leftby May 2025
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