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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
Pivotal Trial
Summary
This trial tests a medication called TNX-102 SL, taken as two tablets at bedtime, to help people with fibromyalgia. The medication dissolves under the tongue and aims to improve sleep and reduce pain.
Eligible Conditions
- Fibromyalgia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Pain Score
Secondary study objectives
Fibromyalgia
Side effects data
From 2015 Phase 3 trial • 158 Patients • NCT0201523413%
Sinusitis
10%
Fatigue
8%
Upper respiratory tract infection
5%
Constipation
5%
Somnolence
5%
Paraesthesia
3%
Glossodynia
1%
Anxiety
1%
Intraductal proliferative breast lesion
1%
Ankle fracture
1%
Brain stem glioma
1%
Hypoaesthesia oral
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
30 Previous Clinical Trials
4,506 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have certain types of arthritis or autoimmune diseases that are currently active or untreated. This includes rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, systemic lupus erythematosus, untreated or active gout, and other systemic autoimmune diseases.You are male or female 18 to 65 years of age, inclusive.You have been diagnosed with primary fibromyalgia, which is determined by specific criteria set by the American College of Rheumatology.You have been diagnosed with fibromyalgia according to the latest guidelines from the American College of Rheumatology.
Research Study Groups:
This trial has the following groups:- Group 1: TNX-102 SL Tablet, 2.8 mg
- Group 2: Placebo SL Tablet
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Fibromyalgia Patient Testimony for trial: Trial Name: NCT05273749 — Phase 3
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