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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)

Primary Purpose

Fibromyalgia

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TNX-102 SL
Placebo SL Tablet
Sponsored by
Tonix Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Pain, Sleep, Fibromyalgia, FM

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site
  • Tonix Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TNX-102 SL Tablet, 2.8 mg

Placebo SL Tablet

Arm 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.

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.

Outcomes

Primary Outcome Measures

Mean Pain Score
Change from Baseline to the Week 14 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome.

Secondary Outcome Measures

Fibromyalgia Impact Questionnaire - Revised (FIQ-R)
Change from Baseline in the FIQ-R symptoms domain score at the Week 14 endpoint. Scores on the symptoms domain range from 0 to 90 where a higher score means worse outcome.

Full Information

First Posted
March 1, 2022
Last Updated
September 27, 2023
Sponsor
Tonix Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05273749
Brief Title
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia
Acronym
RESILIENT
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tonix Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Pain, Sleep, Fibromyalgia, FM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
470 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TNX-102 SL Tablet, 2.8 mg
Arm Type
Experimental
Arm 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.
Arm Title
Placebo SL Tablet
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
TNX-102 SL
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo SL Tablet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Pain Score
Description
Change from Baseline to the Week 14 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome.
Time Frame
Week 14
Secondary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire - Revised (FIQ-R)
Description
Change from Baseline in the FIQ-R symptoms domain score at the Week 14 endpoint. Scores on the symptoms domain range from 0 to 90 where a higher score means worse outcome.
Time Frame
Week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Sullivan, MD
Organizational Affiliation
Tonix Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Tonix Clinical Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Tonix Clinical Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Tonix Clinical Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Tonix Clinical Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Tonix Clinical Site
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Tonix Clinical Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Tonix Clinical Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Tonix Clinical Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Tonix Clinical Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Tonix Clinical Site
City
Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
Country
United States
Facility Name
Tonix Clinical Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Tonix Clinical Site
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Tonix Clinical Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Tonix Clinical Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Tonix Clinical Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Tonix Clinical Site
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Tonix Clinical Site
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Tonix Clinical Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Tonix Clinical Site
City
Prairieville
State/Province
Louisiana
ZIP/Postal Code
70769
Country
United States
Facility Name
Tonix Clinical Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Tonix Clinical Site
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39501
Country
United States
Facility Name
Tonix Clinical Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Tonix Clinical Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Tonix Clinical Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Tonix Clinical Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Tonix Clinical Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Tonix Clinical Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Tonix Clinical Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Tonix Clinical Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Tonix Clinical Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Facility Name
Tonix Clinical Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Tonix Clinical Site
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Tonix Clinical Site
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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