NCT06636786 - Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) | Biotech Hunter

Enrollment

180

Participants

Timeline

Start Date

March 25, 2025

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions

Acute Stress ReactionAcute Stress DisorderNeurocognitive FunctionPost-traumatic Stress

Interventions

DRUG

Cyclobenzaprine HCl

TNX-102 SL (cyclobenzaprine HCl sublingual tablets) taken sublingually (under the tongue) in the ED and each day at bedtime for a total of 2 weeks.

DRUG

Placebo

Placebo sublingual tablets taken sublingually (under the tongue) in the ED and each day at bedtime for a total of 2 weeks.

Trial Locations (6)

46202

RECRUITING

Indiana University, Indianapolis

63110

RECRUITING

Washington University in St. Louis, St Louis

66160

RECRUITING

University of Kansas Medical Center, Kansas City

01655

RECRUITING

University of Massachusetts Chan Medical School (Umass Memorial Medical Center), Worcester

02903

RECRUITING

Rhode Island Hospital, Providence

RECRUITING

The Miriam Hospital, Providence

All Listed Sponsors

collaborator

United States Department of Defense

FED

collaborator

Tonix Pharmaceuticals, Inc.

INDUSTRY

collaborator

Mclean Hospital

OTHER

collaborator

Cooper University Health Care

OTHER

lead

University of North Carolina, Chapel Hill

OTHER