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

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

Sponsors

Lead Sponsor: Tonix Pharmaceuticals, Inc.

Source Tonix Pharmaceuticals, Inc.
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.

Overall Status Active, not recruiting
Start Date December 9, 2019
Completion Date October 2020
Primary Completion Date October 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean Pain Score Week 14
Secondary Outcome
Measure Time Frame
Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Week 14
Enrollment 470
Condition
Intervention

Intervention Type: Drug

Intervention Name: TNX-102 SL

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.

Arm Group Label: TNX-102 SL Tablet, 2.8 mg

Other Name: Low dose cyclobenzaprine sublingual tablets

Intervention Type: Drug

Intervention Name: Placebo SL Tablet

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.

Arm Group Label: Placebo SL Tablet

Other Name: Placebo sublingual tablets

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).

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Gregory Sullivan, MD Study Director Tonix Pharmaceuticals
Location
Facility:
Tonix Clinical Site | Birmingham, Alabama, 35216, United States
Tonix Clinical Site | Phoenix, Arizona, 85016, United States
Tonix Clinical Site | Oceanside, California, 92056, United States
Tonix Clinical Site | Sacramento, California, 95831, United States
Tonix Clinical Site | San Diego, California, 92103, United States
Tonix Clinical Site | Temecula, California, 32591, United States
Tonix Clinical Site | Cromwell, Connecticut, 06416, United States
Tonix Clinical Site | Fort Myers, Florida, 33912, United States
Tonix Clinical Site | Jacksonville, Florida, 32256, United States
Tonix Clinical Site | North Miami, Florida, 33161, United States
Tonix Clinical Site | Ocala, Florida, 34470, United States
Tonix Clinical Site | Orlando, Florida, 32801, United States
Tonix Clinical Site | Atlanta, Georgia, 30341, United States
Tonix Clinical Site | Evansville, Indiana, 47714, United States
Tonix Clinical Site | West Des Moines, Iowa, 50265, United States
Tonix Clinical Site | Prairie Village, Kansas, 66208, United States
Tonix Clinical Site | New Orleans, Louisiana, 70115, United States
Tonix Clinical Site | Boston, Massachusetts, 02131, United States
Tonix Clinical Site | North Dartmouth, Massachusetts, 02747, United States
Tonix Clinical Site | Las Vegas, Nevada, 89102, United States
Tonix Clinical Site | Williamsville, New York, 14221, United States
Tonix Clinical Site | High Point, North Carolina, 27262, United States
Tonix Clinical Site | Raleigh, North Carolina, 27612, United States
Tonix Clinical Site | Fargo, North Dakota, 58104, United States
Tonix Clinical Site | Cincinnati, Ohio, 45219, United States
Tonix Clinical Site | Dayton, Ohio, 45417, United States
Tonix Clinical Site | North Canton, Ohio, 44720, United States
Tonix Clinical Site | Oklahoma City, Oklahoma, 73112, United States
Tonix Clinical Site | Tulsa, Oklahoma, 74133, United States
Tonix Clinical Site | Portland, Oregon, 97210, United States
Tonix Clinical Site | Allentown, Pennsylvania, 18104, United States
Tonix Clinical Site | Warwick, Rhode Island, 02886, United States
Tonix Clinical Site | Chattanooga, Tennessee, 37421, United States
Tonix Clinical Site | Memphis, Tennessee, 38119, United States
Tonix Clinical Site | Austin, Texas, 78737, United States
Tonix Clinical Site | Dallas, Texas, 75231, United States
Tonix Clinical Site | Salt Lake City, Utah, 84102, United States
Tonix Clinical Site | Charlottesville, Virginia, 22911, United States
Tonix Clinical Site | Kenosha, Wisconsin, 53144, United States
Location Countries

United States

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: TNX-102 SL Tablet, 2.8 mg

Type: Experimental

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.

Label: Placebo SL Tablet

Type: Placebo Comparator

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.

Acronym RELIEF
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov