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A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

NCT ID: NCT04508621

Last Updated: 2023-12-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

514 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-22

Study Completion Date

2021-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia

Keywords

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Pain Sleep Fibromyalgia FM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TNX-102 SL Tablet, 5.6 mg

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.

Group Type EXPERIMENTAL

TNX-102 SL

Intervention Type DRUG

Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.

Placebo SL Tablet

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.

Group Type PLACEBO_COMPARATOR

Placebo SL Tablet

Intervention Type DRUG

Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.

Interventions

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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 patient will have the dose increased to 2 tablets for 12 weeks.

Intervention Type DRUG

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 patient will have the dose increased to 2 tablets for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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Low dose cyclobenzaprine sublingual tablets Placebo sublingual tablets

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tonix Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory Sullivan, MD

Role: STUDY_DIRECTOR

Tonix Pharmaceuticals, Inc.

Locations

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Tonix Clinical Site

Birmingham, Alabama, United States

Site Status

Tonix Clinical Site

Phoenix, Arizona, United States

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Tonix Clinical Site

Oceanside, California, United States

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Tonix Clinical Site

San Diego, California, United States

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Tonix Clinical Site

Santa Ana, California, United States

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Tonix Clinical Site

Temecula, California, United States

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Tonix Clinical Site

Cromwell, Connecticut, United States

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Tonix Clinical Site

Fort Myers, Florida, United States

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Tonix Clinical Site

Jacksonville, Florida, United States

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Tonix Clinical Site

North Miami, Florida, United States

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Tonix Clinical Site

Ocala, Florida, United States

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Tonix Clinical Site

Orlando, Florida, United States

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Tonix Clinical Site

Alpharetta, Georgia, United States

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Tonix Clinical Site

Evansville, Indiana, United States

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Tonix Clinical Site

West Des Moines, Iowa, United States

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Tonix Clinical Site

Prairie Village, Kansas, United States

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Tonix Clinical Site

New Orleans, Louisiana, United States

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Tonix Clinical Site

Boston, Massachusetts, United States

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Tonix Clinical Site

Albuquerque, New Mexico, United States

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Tonix Clinical Site

Williamsville, New York, United States

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Tonix Clinical Site

High Point, North Carolina, United States

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Tonix Clinical Site

Raleigh, North Carolina, United States

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Tonix Clinical Site

Cincinnati, Ohio, United States

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Tonix Clinical Site

Dayton, Ohio, United States

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Tonix Clinical Site

North Canton, Ohio, United States

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Tonix Clinical Site

Oklahoma City, Oklahoma, United States

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Tonix Clinical Site

Tulsa, Oklahoma, United States

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Tonix Clinical Site

Portland, Oregon, United States

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Tonix Clinical Site

Warwick, Rhode Island, United States

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Tonix Clinical Site

Chattanooga, Tennessee, United States

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Tonix Clinical Site

Memphis, Tennessee, United States

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Tonix Clinical Site

Austin, Texas, United States

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Tonix Clinical Site

Dallas, Texas, United States

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Tonix Clinical Site

Salt Lake City, Utah, United States

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Tonix Clinical Site

Charlottesville, Virginia, United States

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Tonix Clinical Site

Kenosha, Wisconsin, United States

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Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TNX-CY-F306

Identifier Type: -

Identifier Source: org_study_id