[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565023":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":40,"locations":47,"responsibleParty":196,"collaborators":198,"id":208,"slug":209,"hasResults":210,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":210,"sex":216,"minAge":217,"maxAge":218,"enrollmentInfo":219,"targetDuration":45,"studyType":222,"phases":223,"briefSummary":225,"conditions":226,"keywords":45,"overallStatus":69,"whyStopped":45,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cyclobenzaprine HCl","EXPERIMENTAL","Participants will be instructed to take a half dose (equivalent to 1 tablet, 2.8 mg) of Cyclobenzaprine HCl in the ED as part of enrollment procedures. If the time between the first half dose and the planned bedtime of the participant is less than 6 hours, participants will be instructed to take 1 tablet (half dose) the first night at bedtime. If the time between the first half dose and planned bedtime of the participant is greater than or equal to 6 hours, then participants will be instructed to take a full dose (equivalent to 2 tablets) the first night. Over the following 13 days, all participants will be instructed to take a full dose of the study drug at bedtime. Each participant will receive 29 tablets and take either 28 or 29 tablets total for the duration of study participation.",[13],"Drug: Cyclobenzaprine HCl",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will be instructed to take a half dose (equivalent to 1 tablet, 2.8 mg) of placebo in the ED as part of enrollment procedures. The placebo is the same formulation as active except the Cyclobenzaprine HCl content is replaced by Mannitol to maintain the same tablet weight and dimensions. If the time between the first half dose and the planned bedtime of the participant is less than 6 hours, participants will be instructed to take 1 tablet (half dose) the first night at bedtime. If the time between the first half dose and planned bedtime of the participant is greater than or equal to 6 hours, then participants will be instructed to take a full dose (equivalent to 2 tablets) the first night. Over the following 13 days, all participants will be instructed to take a full dose of the study drug at bedtime. Each participant will receive 29 tablets and take either 28 or 29 tablets total for the duration of study participation.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","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.",[9],[26],"TNX-102 SL",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Placebo sublingual tablets taken sublingually (under the tongue) in the ED and each day at bedtime for a total of 2 weeks.",[15],[31],"Sugar pill",[33,37],{"name":34,"affiliation":35,"role":36},"Samuel McLean, MD","University of North Carollina at Chapel Hill","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":39,"role":36},"Christopher Jones, MD","Cooper University Health Care",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Romina Soudavari","CONTACT","9843195030",null,"romina_soudavari@med.unc.edu",[48,67,85,105,122,137,152,173,181],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University of Alabama at Birmingham","NOT_YET_RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-86.80249,33.52066,{"lat":60,"lon":59},[63,65],{"name":64,"role":43,"phone":45,"phoneExt":45,"email":45},"Whitney Taylor",{"name":66,"role":36,"phone":45,"phoneExt":45,"email":45},"Lauren Walter",{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":54,"countryCode":55,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Indiana University","RECRUITING","Indianapolis","Indiana","46202",{"type":57,"coordinates":74},[75,76],-86.15804,39.76838,{"lat":76,"lon":75},[79,83],{"name":80,"role":43,"phone":81,"phoneExt":45,"email":82},"Leah Emmons","463-274-2373","ldemmons@iu.edu",{"name":84,"role":36,"phone":45,"phoneExt":45,"email":45},"Paul Musey, MD",{"facility":86,"status":69,"city":87,"state":88,"zip":89,"country":54,"countryCode":55,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"University of Kansas Medical Center","Kansas City","Kansas","66160",{"type":57,"coordinates":91},[92,93],-94.62746,39.11417,{"lat":93,"lon":92},[96,100,102],{"name":97,"role":43,"phone":98,"phoneExt":45,"email":99},"Lucas Lemar","913-588-3580","llemar@kumc.edu",{"name":101,"role":36,"phone":45,"phoneExt":45,"email":45},"Lindsay Maguire, MD",{"name":103,"role":104,"phone":45,"phoneExt":45,"email":45},"Chad Cannon, MD","SUB_INVESTIGATOR",{"facility":106,"status":69,"city":107,"state":108,"zip":109,"country":54,"countryCode":55,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Washington University in St. Louis","St Louis","Missouri","63110",{"type":57,"coordinates":111},[112,113],-90.19789,38.62727,{"lat":113,"lon":112},[116,120],{"name":117,"role":43,"phone":118,"phoneExt":45,"email":119},"Jamie Mills","314-273-1382","jamiem@wustl.edu",{"name":121,"role":36,"phone":45,"phoneExt":45,"email":45},"Stacey House, MD",{"facility":123,"status":69,"city":124,"state":125,"zip":126,"country":54,"countryCode":55,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Cooper University Health System","Camden","New Jersey","08103",{"type":57,"coordinates":128},[129,130],-75.11962,39.92595,{"lat":130,"lon":129},[133,135],{"name":134,"role":43,"phone":45,"phoneExt":45,"email":45},"Dylan Kurowsky",{"name":136,"role":36,"phone":45,"phoneExt":45,"email":45},"Christopher Jones",{"facility":138,"status":69,"city":139,"state":140,"zip":141,"country":54,"countryCode":55,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"The Ohio State University","Columbus","Ohio","43210",{"type":57,"coordinates":143},[144,145],-82.99879,39.96118,{"lat":145,"lon":144},[148,150],{"name":149,"role":43,"phone":45,"phoneExt":45,"email":45},"Hawa Sall",{"name":151,"role":36,"phone":45,"phoneExt":45,"email":45},"Michael Lyons",{"facility":153,"status":69,"city":154,"state":155,"zip":156,"country":54,"countryCode":55,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Rhode Island Hospital","Providence","Rhode Island","02903",{"type":57,"coordinates":158},[159,160],-71.41283,41.82399,{"lat":160,"lon":159},[163,167,171],{"name":164,"role":43,"phone":165,"phoneExt":45,"email":166},"Carolyn Ortega","401-444-6619","cortega@lifespan.org",{"name":168,"role":43,"phone":169,"phoneExt":45,"email":170},"Sarah Tokarz","401-606-9815","stokarz1@lifespan.org",{"name":172,"role":36,"phone":45,"phoneExt":45,"email":45},"Adam Aluisio, MD",{"facility":174,"status":69,"city":154,"state":155,"zip":156,"country":54,"countryCode":55,"cosmosGeoPoint":175,"geoPoint":177,"contacts":178},"The Miriam Hospital",{"type":57,"coordinates":176},[159,160],{"lat":160,"lon":159},[179,180],{"name":164,"role":43,"phone":165,"phoneExt":45,"email":166},{"name":172,"role":36,"phone":45,"phoneExt":45,"email":45},{"facility":182,"status":50,"city":183,"state":184,"zip":185,"country":54,"countryCode":55,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"University of Texas Health Science Center at San Antonio","San Antonio","Texas","78229",{"type":57,"coordinates":187},[188,189],-98.49363,29.42412,{"lat":189,"lon":188},[192,194],{"name":193,"role":43,"phone":45,"phoneExt":45,"email":45},"Stephanie Perez",{"name":195,"role":36,"phone":45,"phoneExt":45,"email":45},"Ralph Riviello",{"type":197,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[199,202,205,207],{"name":200,"class":201},"United States Department of Defense","FED",{"name":203,"class":204},"Tonix Pharmaceuticals, Inc.","INDUSTRY",{"name":206,"class":6},"Mclean Hospital",{"name":39,"class":6},"100565023","phase-2-preventionreduction-of-asrs-and-ptsd-to-sustain-civilian-performance-with-sublingual-cyclobenzaprine-hcl-tnx-102-sl-100565023",false,"NCT06636786","Prevention\u002FReduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)","Prevention\u002FReduction 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)","OASIS","Inclusion Criteria:\n\n1. ≥ 18 years and ≤ 55 years of age\n2. Presentation to ED within 72 hours of MVC\n3. Anticipated to be discharged home from the ED\n4. Stated willingness to comply with all study procedures and availability for the duration of the study\n5. Consent to receive unencrypted communications\n6. Has a smartphone with continuous service for ≥ 1 year\n7. Has a personal email address they regularly access\n8. Able to speak and read English\n9. Pain severity in the ED ≥ 4 (0-10 numeric rating scale)\n10. People who are not of childbearing potential (e.g., hysterectomy, bilateral oophorectomy, or confirmed postmenopausal for at least last 12 consecutive months)\n11. People with the capacity to conceive a pregnancy must agree to employ a highly effective form of birth control throughout the first 21 days of study participation (e.g., oral, injected, transdermal, or implanted hormonal methods of contraception for at least one full menstrual cycle prior to study drug administration; placement of an intrauterine device (IUD) or intrauterine system (IUS); or double barrier methods such as condoms and diaphragms)\n\nExclusion Criteria:\n\n1. Substantial comorbid injury (e.g., long bone fracture)\n2. People of childbearing potential who are pregnant, breastfeeding, planning to become pregnant, or not using a highly effective form of contraception (e.g., implants, intrauterine devices (IUDs), tubal ligation, hormonal birth control pills, patches, vaginal rings, or injections) during their participation\n3. Prisoner status\n4. Any chronic daily opioid use prior to MVC\n5. Active psychosis, suicidal ideation, or homicidal ideation\n6. Plans for hospital admission\n7. History of arrhythmias, heart block or conduction disturbances, congestive heart failure\n8. Currently in the acute recovery phase of myocardial infarction\n9. Hypersensitivity to cyclobenzaprine or the excipient in TNX-102 SL or placebo formulations\n10. History of urinary retention, angle-closure glaucoma, increased intraocular pressure, or hyperthyroidism (TSH \\\u003C lower limit of normal)\n11. Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation due to risk of potential fatal drug-drug interactions\n12. Current or planned use of the following prohibited concomitant medications during study participation: anticholinergic medications, guanethidine, selective serotonin reuptake inhibitors (SSRIs) , serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, MAO inhibitors, anticholinergic medications, guanethidine, potent cytochrome P450 subtype 3A4 inhibitor, St. John's wort, chronic use muscle relaxants or planned use after MCV or other prohibited concomitant medications listed in section 5.6. PI to assess individual cases where single dose of muscle relaxant is prescribed in ED for inclusion\n13. Any hepatic impairment or renal disease (defined as AST OR ALT \\> 3 times the upper limit of normal) or renal disease (defined as GFR ≤ 80 mL\u002Fmin)\n14. Lacking capacity to provide informed consent (receipt of sedative, hypnotic agent making the patient non-decisional for consent)\n15. Any other history or condition that would, in the site investigator's judgement, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g., might interfere with the study, confound interpretation, or endanger patient)\n16. Elevated baseline blood pressure defined as systolic blood pressure ≥ 170 mmHg or diastolic blood pressure ≥ 100 mmHg and or elevated heart rate of ≥115\n17. Abnormal baseline ECG as defined as: QRS duration ≥ 120 ms; QTc \\> 460 ms; not in sinus rhythm; or 1st, 2nd, or 3rd degree heart block indicated\n18. Substance or alcohol use disorder, bipolar disorder, or schizophrenia\n19. History of severe or unexplained oral, or oropharyngeal swelling or edema","ALL","18 Years","55 Years",{"count":220,"type":221},180,"ESTIMATED","INTERVENTIONAL",[224],"PHASE2","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, treats\u002Freduces acute stress reaction (ASR)\u002Facute stress disorder (ASD) symptoms (primary outcome), improves neurocognitive function, and prevents\u002Freduces 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.",[227,228,229,230],"Acute Stress Reaction","Acute Stress Disorder","Neurocognitive Function","Post-traumatic Stress","2026-04-09",{"date":233,"type":234},"2026-04-13","ACTUAL",{"date":236,"type":234},"2025-03-25",{"date":238,"type":221},"2026-09",{"name":5,"class":6},9]