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

Fibromyalgia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04172831
• Other study ID #: TNX-CY-F304
• Status: Completed
• Phase: Phase 3
• Start date: December 9, 2019
• Est. completion date: October 29, 2020

Study information

• Verified date: July 2022
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: October 29, 2020
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• TNX-102 SL
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.
• Placebo SL Tablet
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.

Locations

Country	Name	City	State
United States	Tonix Clinical Site	Allentown	Pennsylvania
United States	Tonix Clinical Site	Atlanta	Georgia
United States	Tonix Clinical Site	Austin	Texas
United States	Tonix Clinical Site	Birmingham	Alabama
United States	Tonix Clinical Site	Boston	Massachusetts
United States	Tonix Clinical Site	Charlottesville	Virginia
United States	Tonix Clinical Site	Chattanooga	Tennessee
United States	Tonix Clinical Site	Cincinnati	Ohio
United States	Tonix Clinical Site	Cromwell	Connecticut
United States	Tonix Clinical Site	Dallas	Texas
United States	Tonix Clinical Site	Dayton	Ohio
United States	Tonix Clinical Site	Evansville	Indiana
United States	Tonix Clinical Site	Fargo	North Dakota
United States	Tonix Clinical Site	Fort Myers	Florida
United States	Tonix Clinical Site	High Point	North Carolina
United States	Tonix Clinical Site	Jacksonville	Florida
United States	Tonix Clinical Site	Kenosha	Wisconsin
United States	Tonix Clinical Site	Las Vegas	Nevada
United States	Tonix Clinical Site	Memphis	Tennessee
United States	Tonix Clinical Site	New Orleans	Louisiana
United States	Tonix Clinical Site	North Canton	Ohio
United States	Tonix Clinical Site	North Dartmouth	Massachusetts
United States	Tonix Clinical Site	North Miami	Florida
United States	Tonix Clinical Site	Ocala	Florida
United States	Tonix Clinical Site	Oceanside	California
United States	Tonix Clinical Site	Oklahoma City	Oklahoma
United States	Tonix Clinical Site	Orlando	Florida
United States	Tonix Clinical Site	Phoenix	Arizona
United States	Tonix Clinical Site	Portland	Oregon
United States	Tonix Clinical Site	Prairie Village	Kansas
United States	Tonix Clinical Site	Raleigh	North Carolina
United States	Tonix Clinical Site	Sacramento	California
United States	Tonix Clinical Site	Salt Lake City	Utah
United States	Tonix Clinical Site	San Diego	California
United States	Tonix Clinical Site	Temecula	California
United States	Tonix Clinical Site	Tulsa	Oklahoma
United States	Tonix Clinical Site	Warwick	Rhode Island
United States	Tonix Clinical Site	West Des Moines	Iowa
United States	Tonix Clinical Site	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	14 weeks
Secondary	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.	14 weeks
Secondary	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.	14 weeks
Secondary	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.	14 weeks
Secondary	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.	14 weeks
Secondary	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.	14 weeks
Secondary	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).	14 weeks