A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia

PHASE3CompletedINTERVENTIONAL
Enrollment

457

Participants

Timeline

Start Date

April 6, 2022

Primary Completion Date

November 14, 2023

Study Completion Date

November 14, 2023

Conditions
Fibromyalgia
Interventions
DRUG

TNX-102 SL Tablet, 5.6 mg

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.

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

Trial Locations (33)

14221

Tonix Clinical Site, Williamsville

22911

Tonix Clinical Site, Charlottesville

24541

Tonix Clinical Site, Danville

29407

Tonix Clinical Site, Charleston

30022

Tonix Clinical Site, Alpharetta

30329

Tonix Clinical Site, Atlanta

32256

Tonix Clinical Site, Jacksonville

32801

Tonix Clinical Site, Orlando

33016

Tonix Clinical Site, Miami Lakes

33912

Tonix Clinical Site, Fort Myers

34470

Tonix Clinical Site, Ocala

34677

Tonix Clinical Site, Oldsmar

39501

Tonix Clinical Site, Gulfport

45219

Tonix Clinical Site, Cincinnati

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

70433

Tonix Clinical Site, Covington

70769

Tonix Clinical Site, Prairieville

74133

Tonix Clinical Site, Tulsa

75070

Tonix Clinical Site, McKinney

75231

Tonix Clinical Site, Dallas

78737

Tonix Clinical Site, Austin

85012

Tonix Clinical Site, Phoenix

87109

Tonix Clinical Site, Albuquerque

92056

Tonix Clinical Site, Oceanside

92591

Tonix Clinical Site, Temecula

92705

Tonix Clinical Site, Santa Ana

97210

Tonix Clinical Site, Portland

06416

Tonix Clinical Site, Cromwell

02131

Tonix Clinical Site, Boston

All Listed Sponsors
lead

Tonix Pharmaceuticals, Inc.

INDUSTRY