Fibromyalgia Clinical Trial
— RALLYOfficial 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
Verified date | December 2023 |
Source | Tonix Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 514 |
Est. completion date | November 1, 2021 |
Est. primary completion date | November 1, 2021 |
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 defined range. Exclusion Criteria: - History of or evidence for a diagnosis of borderline personality disorder (BPD). |
Country | Name | City | State |
---|---|---|---|
United States | Tonix Clinical Site | Albuquerque | New Mexico |
United States | Tonix Clinical Site | Alpharetta | 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 | 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 | Memphis | Tennessee |
United States | Tonix Clinical Site | New Orleans | Louisiana |
United States | Tonix Clinical Site | North Canton | Ohio |
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 | Salt Lake City | Utah |
United States | Tonix Clinical Site | San Diego | California |
United States | Tonix Clinical Site | Santa Ana | 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 |
Lead Sponsor | Collaborator |
---|---|
Tonix Pharmaceuticals, Inc. |
United States,
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 (FIQ-R) 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 FIQ-R Function Domain Score | The FIQ-R is a validated questionnaire. Score 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 consist 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 |
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