Clinical trial NCT04508621: A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: Pain
Sleep
Fibromyalgia
FM
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-11
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 defined range.

Exclusion Criteria:

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

Primary outcomes:
measure: Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.
timeFrame: 14 weeks
Secondary outcomes:
measure: Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved"
timeFrame: 14 weeks
measure: Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score.
timeFrame: 14 weeks
measure: Change From Baseline to Week 14 in the FIQ-R Function Domain Score
timeFrame: 14 weeks
measure: Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance
timeFrame: 14 weeks
measure: Change From Baseline to Week 14 in the PROMIS Score for Fatigue
timeFrame: 14 weeks
measure: Change From Baseline to Week 14 in the Weekly Average of the Daily Diary Assessment of Sleep Quality
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Tonix Clinical Site
state: Alabama
city: Phoenix
country: United States
facility: Tonix Clinical Site
state: Arizona
city: Oceanside
country: United States
facility: Tonix Clinical Site
state: California
city: San Diego
country: United States
facility: Tonix Clinical Site
state: California
city: Santa Ana
country: United States
facility: Tonix Clinical Site
state: California
city: Temecula
country: United States
facility: Tonix Clinical Site
state: California
city: Cromwell
country: United States
facility: Tonix Clinical Site
state: Connecticut
city: Fort Myers
country: United States
facility: Tonix Clinical Site
state: Florida
city: Jacksonville
country: United States
facility: Tonix Clinical Site
state: Florida
city: North Miami
country: United States
facility: Tonix Clinical Site
state: Florida
city: Ocala
country: United States
facility: Tonix Clinical Site
state: Florida
city: Orlando
country: United States
facility: Tonix Clinical Site
state: Florida
city: Alpharetta
country: United States
facility: Tonix Clinical Site
state: Georgia
city: Evansville
country: United States
facility: Tonix Clinical Site
state: Indiana
city: West Des Moines
country: United States
facility: Tonix Clinical Site
state: Iowa
city: Prairie Village
country: United States
facility: Tonix Clinical Site
state: Kansas
city: New Orleans
country: United States
facility: Tonix Clinical Site
state: Louisiana
city: Boston
country: United States
facility: Tonix Clinical Site
state: Massachusetts
city: Albuquerque
country: United States
facility: Tonix Clinical Site
state: New Mexico
city: Williamsville
country: United States
facility: Tonix Clinical Site
state: New York
city: High Point
country: United States
facility: Tonix Clinical Site
state: North Carolina
city: Raleigh
country: United States
facility: Tonix Clinical Site
state: North Carolina
city: Cincinnati
country: United States
facility: Tonix Clinical Site
state: Ohio
city: Dayton
country: United States
facility: Tonix Clinical Site
state: Ohio
city: North Canton
country: United States
facility: Tonix Clinical Site
state: Ohio
city: Oklahoma City
country: United States
facility: Tonix Clinical Site
state: Oklahoma
city: Tulsa
country: United States
facility: Tonix Clinical Site
state: Oklahoma
city: Portland
country: United States
facility: Tonix Clinical Site
state: Oregon
city: Warwick
country: United States
facility: Tonix Clinical Site
state: Rhode Island
city: Chattanooga
country: United States
facility: Tonix Clinical Site
state: Tennessee
city: Memphis
country: United States
facility: Tonix Clinical Site
state: Tennessee
city: Austin
country: United States
facility: Tonix Clinical Site
state: Texas
city: Dallas
country: United States
facility: Tonix Clinical Site
state: Texas
city: Salt Lake City
country: United States
facility: Tonix Clinical Site
state: Utah
city: Charlottesville
country: United States
facility: Tonix Clinical Site
state: Virginia
city: Kenosha
country: United States
facility: Tonix Clinical Site
state: Wisconsin
Study officials:
affiliation: Tonix Pharmaceuticals, Inc.
name: Gregory Sullivan, MD
role: STUDY_DIRECTOR
References: