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A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia (RELIEF)

Primary Purpose

Fibromyalgia

Status
Completed
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)
  • The in-clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol specified range.

Exclusion Criteria:

  • History of or evidence for a diagnosis of borderline personality disorder (BPD).

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
  • 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 Tablets, 5.6 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

Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.
Patients provide a daily numeric assessment of their average pain (24-hour recall), via an electronic diary, using an 11-point NRS. Scores range from 0 (no pain) to 10 (worst possible pain).

Secondary Outcome Measures

Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved"
The PGIC is a fibromyalgia specific validated instrument on a scale of 1 to 7, where a score of 1 indicates the highest level of improvement and a score of 7 indicates a much worse outcome.
Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score
The FIQ-R is a validated questionnaire. Scores on the symptoms domain range from 0 to 100 where a higher score means worse outcome.
Change From Baseline to Week 14 in the FIQR Function Domain Score
The FIQ-R is a validated questionnaire. Scores on the function domain range from 0 to 90 where a higher score means worse outcome.
Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance
The PROMIS Sleep disturbance short form 8a consists of 8 questions on a 5-point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40.
Change From Baseline to Week 14 in the PROMIS Score for Fatigue
The PROMIS fatigue short form 8a consists of 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40.
Change From Baseline to Week 14 in the Weekly Average of the Daily Diary Assessment of Sleep Quality
Patients provide a daily numeric assessment of their sleep quality for the previous night, via an electronic diary, using an 11-point NRS. Scores range from 0 (best possible sleep) to 10 (worst possible sleep).

Full Information

First Posted
November 20, 2019
Last Updated
July 13, 2022
Sponsor
Tonix Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04172831
Brief Title
A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Acronym
RELIEF
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
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
October 29, 2020 (Actual)
Study Completion Date
October 29, 2020 (Actual)

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

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
503 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TNX-102 SL Tablets, 5.6 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
Other Intervention Name(s)
Low dose cyclobenzaprine sublingual tablets
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
Other Intervention Name(s)
Placebo sublingual tablets
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
Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.
Description
Patients provide a daily numeric assessment of their average pain (24-hour recall), via an electronic diary, using an 11-point NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved"
Description
The PGIC is a fibromyalgia specific validated instrument on a scale of 1 to 7, where a score of 1 indicates the highest level of improvement and a score of 7 indicates a much worse outcome.
Time Frame
14 weeks
Title
Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score
Description
The FIQ-R is a validated questionnaire. Scores on the symptoms domain range from 0 to 100 where a higher score means worse outcome.
Time Frame
14 weeks
Title
Change From Baseline to Week 14 in the FIQR Function Domain Score
Description
The FIQ-R is a validated questionnaire. Scores on the function domain range from 0 to 90 where a higher score means worse outcome.
Time Frame
14 weeks
Title
Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance
Description
The PROMIS Sleep disturbance short form 8a consists of 8 questions on a 5-point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40.
Time Frame
14 weeks
Title
Change From Baseline to Week 14 in the PROMIS Score for Fatigue
Description
The PROMIS fatigue short form 8a consists of 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40.
Time Frame
14 weeks
Title
Change From Baseline to Week 14 in the Weekly Average of the Daily Diary Assessment of Sleep Quality
Description
Patients provide a daily numeric assessment of their sleep quality for the previous night, via an electronic diary, using an 11-point NRS. Scores range from 0 (best possible sleep) to 10 (worst possible sleep).
Time Frame
14 weeks

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) The in-clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol specified range. Exclusion Criteria: History of or evidence for a diagnosis of borderline personality disorder (BPD).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Sullivan, MD
Organizational Affiliation
Tonix Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Tonix Clinical Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Tonix Clinical Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
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
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
Facility Name
Tonix Clinical Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Tonix Clinical Site
City
Temecula
State/Province
California
ZIP/Postal Code
32591
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
North Miami
State/Province
Florida
ZIP/Postal Code
33161
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
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Tonix Clinical Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
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
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
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
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Tonix Clinical Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
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
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Tonix Clinical Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Tonix Clinical Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
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
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Tonix Clinical Site
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
Tonix Clinical Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
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
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Tonix Clinical Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Tonix Clinical Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Tonix Clinical Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
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
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
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
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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