[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654611":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":26,"studyPopulation":17,"armGroups":27,"interventions":38,"overallOfficials":52,"centralContacts":57,"locations":67,"responsibleParty":92,"collaborators":17,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":17,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":17,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":116,"whyStopped":17,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Primus Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change from baseline to approximately 4 hours post-dose, in mean reaction time to a stimulus as measured in milliseconds by the Reaction Time Test (RTT)","Measures the time between a visual stimulus and response, measured in milliseconds","Baseline dose to four (4 ) hours post-dose",{"measure":14,"description":15,"timeFrame":16},"Change from baseline to approximately 4 hours post-dose of delayed response exceeding a predefined threshold >300 ms as measured by the Reaction Time Test (RTT)","measures the time between a visual stimulus and response, measured in milliseconds","Baseline dose to approximately 4 hours post-dose",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","CROSSOVER","BASIC_SCIENCE",{"masking":23,"maskingDescription":17,"whoMasked":24},"SINGLE",[25],"PARTICIPANT","Healthy participants will take one dose of a drug after eating a meal. When the drug is at the highest level in their blood, testing for drowsiness and the risk of falling will take place. Brain wave monitoring known as an EEG will take place throughout the testing. Participants will take a second dose of the drug with the same testing one week later.",[28,34],{"label":29,"type":30,"description":31,"interventionNames":32},"Active metaxalone m640 mg","ACTIVE_COMPARATOR","One dose administered after a standard meal with testing Baseline dose to time of maximum concentration (Tmax)",[33],"Drug: Metaxalone 640 mg",{"label":35,"type":30,"description":31,"interventionNames":36},"Active metaxalone 800 mg",[37],"Drug: Metaxalone 800 MG",[39,46],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","Metaxalone 640 mg","Dose micronized 640 mg",[29],[45],"m640",{"type":40,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Metaxalone 800 MG","The dose is 800 mg",[35],[51],"Skelaxin",[53],{"name":54,"affiliation":55,"role":56},"James Lukban, D.O.","Primus Pharmaceutical, Inc.","STUDY_DIRECTOR",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":17,"email":62},"Project Manager","CONTACT","480-483-1410","mshahbandar@primusrx.com",{"name":64,"role":60,"phone":65,"phoneExt":17,"email":66},"Clinical Manager","480-250-6689","msanstead@primusrx.com",[68],{"facility":69,"status":17,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"AMR Clinical - Columbus","Columbus","Ohio","43213","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-82.99879,39.96118,{"lat":79,"lon":78},[82,86,89],{"name":83,"role":60,"phone":84,"phoneExt":17,"email":85},"Site Manager","614-683-5800","jim.sanders@amr-clinical.com",{"name":87,"role":60,"phone":84,"phoneExt":17,"email":88},"Study Coordinator","kim.burmane@amr-clinical.com",{"name":90,"role":91,"phone":17,"phoneExt":17,"email":17},"Harold Green, MD","PRINCIPAL_INVESTIGATOR",{"type":93,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100654611","phase-4-healthy-participants-will-take-one-dose-of-a-drug-after-eating-a-meal-then-test-for-drowsiness-and-fall-risk-with-brain-wave-monitoring-throughout-the-testing-participants-will-take-a-second-dose-of-the-drug-with-the-same-testing-100654611",false,"NCT07801066","Healthy Person Eats, Takes 1 Dose, Tested for Drowsiness, Fall Risk, Then Takes Second Dose Followed by Same Tests","A Prospective, Randomized, Single-blind, Study to Assess Drowsiness, Cognition, Fall Risk, and Electroencephalographic (EEG) Dynamics After Oral Metaxalone Tablets 640 mg (M640) Versus Metaxalone 800 mg in Healthy Participants","Inclusion Criteria:\n\n* Healthy adults aged 18 to 55 years old\n* Weigh at least 120 pounds\n* Medically healthy\n* Able to sign and date informed consent form\n\nExclusion Criteria:\n\n* Current use of any medications known to affect the sleep-wake cycle\n* Sleep disorder diagnosis\n* Positive urine test for drugs\n* Known history of alcohol use disorder\n* Having a history of cognitive disorders, depression, schizophrenia, panic disorder, or dementia\n* Having difficulty eating high fat meal\n* Participants who are pregnant, nursing or intending to become pregnant during the period of study.\n* Blood Pressure \\> 160\u002F110 or \\\u003C90\u002F50 mmHg.\n* Heart Rate \\>100 or \\\u003C 50\u002F beats per minute.\n* Having a history of seizure disorder or epilepsy.",true,"ALL","18 Years","55 Years",{"count":106,"type":107},20,"ESTIMATED","INTERVENTIONAL",[110],"PHASE4","Health participants take a single dose, perform testing, washout for one week, take a single dose of different formulation, and perform testing for comparison of the 2 doses.",[113],"Healthy Participants",[115],"Fall Risk","NOT_YET_RECRUITING","2026-09-16",{"date":119,"type":120},"2026-09-21","ACTUAL",{"date":122,"type":107},"2026-09-15",{"date":124,"type":107},"2027-01-15",{"name":5,"class":6},1]