Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636786
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
PreventionReduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl TNX-102 SL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PreventionReduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl TNX-102 SL - Optimizing Acute Stress Reaction Interventions With TNX-102 SL - OASIS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OASIS
Brief Summary:
This study will examine the safety and efficacy of TNX-102 SL to reduce ASR symptoms and behavioral changes among patients presenting to the emergency department ED after motor vehicle collision MVC Specifically the investigators will perform the Optimizing Acute Stress reaction Interventions with TNX-102 SL OASIS Trial a double-blind placebo-controlled randomized clinical trial RCT to determine if TNX-102 SL initiated in the ED in the hours after MVC to high risk individuals treatsreduces acute stress reaction ASRacute stress disorder ASD symptoms primary outcome improves neurocognitive function and preventsreduces posttraumatic stress PTS symptoms secondary outcomes long term 180 participants will be randomized receive study drug in ED and be discharged with a 2-week drug supply Prior to initial dose of study drug administration and during the hours days and weeks after participants will receive serial longitudinal assessments of psychological and somatic symptoms neurocognitive function and adverse events
Detailed Description:
US military personnel are exposed to life-threatening traumatic events eg intense firefights with multiple casualties that result in acute stress reaction ASR symptoms ICD-10 and posttraumatic stress PTS Similarly acute and persistent stress symptoms and related adverse posttraumatic neuropsychiatric sequelae are also very common and cause a tremendous burden of suffering in civilian populations following exposure to life-threatening traumatic events eg motor vehicle collision violent or accidental death of a loved one and assault TNX-102 SL cyclobenzaprine HCl sublingual tablet is being developed for the management of fibromyalgia FM and post-traumatic stress disorder PTSD by Tonix Pharmaceuticals Inc the FM program is in mid-Phase 3 development and PTSD is Phase 3 ready In previous PTSD and fibromyalgia studies TNX-102 SL has demonstrated the ability to improve sleep quality which based on published clinical studies of fear memory and stress responsiveness has been shown to play a significant role in stress recovery To date TNX-102 SL has undergone an intense nonclinical and clinical development including Phase 1 2 and 3 studies that assessed safety in over 1180 subjects TNX-102 SL is an extremely promising agent to reduce ASR symptoms and related behavioral changes to enhance resilience and improve warfighter performance and to reduce the frequency and severity of persistentchronic PTS symptoms The results of this study will ultimately provide military personnel veterans and civilians with an important new treatment option that when administered in the early aftermath of traumatic stress exposure can improve recovery job performance and quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None