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

PHASE3CompletedINTERVENTIONAL
Enrollment

514

Participants

Timeline

Start Date

July 22, 2020

Primary Completion Date

November 1, 2021

Study Completion Date

November 1, 2021

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

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.

Trial Locations (36)

14221

Tonix Clinical Site, Williamsville

22911

Tonix Clinical Site, Charlottesville

27262

Tonix Clinical Site, High Point

27612

Tonix Clinical Site, Raleigh

30022

Tonix Clinical Site, Alpharetta

32256

Tonix Clinical Site, Jacksonville

32591

Tonix Clinical Site, Temecula

32801

Tonix Clinical Site, Orlando

33161

Tonix Clinical Site, North Miami

33912

Tonix Clinical Site, Fort Myers

34470

Tonix Clinical Site, Ocala

35216

Tonix Clinical Site, Birmingham

37421

Tonix Clinical Site, Chattanooga

38119

Tonix Clinical Site, Memphis

44720

Tonix Clinical Site, North Canton

45219

Tonix Clinical Site, Cincinnati

45417

Tonix Clinical Site, Dayton

47714

Tonix Clinical Site, Evansville

50265

Tonix Clinical Site, West Des Moines

53144

Tonix Clinical Site, Kenosha

66208

Tonix Clinical Site, Prairie Village

70115

Tonix Clinical Site, New Orleans

73112

Tonix Clinical Site, Oklahoma City

74133

Tonix Clinical Site, Tulsa

75231

Tonix Clinical Site, Dallas

78737

Tonix Clinical Site, Austin

84102

Tonix Clinical Site, Salt Lake City

85016

Tonix Clinical Site, Phoenix

87109

Tonix Clinical Site, Albuquerque

92056

Tonix Clinical Site, Oceanside

92103

Tonix Clinical Site, San Diego

92705

Tonix Clinical Site, Santa Ana

97210

Tonix Clinical Site, Portland

06416

Tonix Clinical Site, Cromwell

02131

Tonix Clinical Site, Boston

02886

Tonix Clinical Site, Warwick

All Listed Sponsors
lead

Tonix Pharmaceuticals, Inc.

INDUSTRY

NCT04508621 - A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia | Biotech Hunter | Biotech Hunter