[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656813":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":24,"armGroups":31,"interventions":38,"overallOfficials":47,"centralContacts":52,"locations":24,"responsibleParty":58,"collaborators":24,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":24,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":24,"enrollmentInfo":69,"targetDuration":24,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":82,"whyStopped":24,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":24},{"fullName":5,"class":6},"Milton S. Hershey Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Number of subjects with vocal cord paralysis after receiving 4-aminopyridine","Evaluate for improvement in vocal cord motion as assessed by an otolaryngologist via repeat flexible laryngoscopy after 3 hours from receiving 4-aminopyridine.","3 hours",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Change in Voice Handicap Index score after receiving 4-aminopyridine","Change in Voice Handicap Index score from baseline to 3 hours from receiving 4-aminopyridine. Range from 0 to 120, 0 meaning minimal voice handicap and 120 meaning significant voice handicap.","baseline to 3 hours",{"measure":19,"description":20,"timeFrame":17},"Change in Eating Assessment Tool-10 score after receiving 4-aminopyridine","Change in Eating Assessment Tool-10 score from baseline to 3 hours from receiving 4-aminopyridine. Range from 0 to 40, 0 meaning no problem with swallowing and 40 meaning severe problem with swallowing.",{"measure":22,"description":23,"timeFrame":17},"Change in Reflux Symptom Index score after receiving 4-aminopyridine","Change in Reflux Symptom Index score from baseline to 3 hours from receiving 4-aminopyridine. Range from 0 to 50, 0 meaning no reflux symptoms and 50 meaning severe reflux symptoms.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE",[32],{"label":33,"type":34,"description":35,"interventionNames":36},"4-Aminopyridine Dose","EXPERIMENTAL","Subjects will receive one dose of oral 4-aminopyridine 10 mg extended release tablet at start of study day prior to initial flexible laryngoscopy exam.",[37],"Drug: 4-Aminopyridine",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","4-Aminopyridine","Subjects will receive one dose of oral dalfampridine 10 mg extended release tablets at start of study day prior to initial flexible laryngoscopy exam.",[33],[45,46],"dalfampridine","Ampyra",[48],{"name":49,"affiliation":50,"role":51},"John P Gniady, MD","Penn State Health Milton S Hershey Medical Center","PRINCIPAL_INVESTIGATOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":24,"email":57},"Christopher C Tseng, MD","CONTACT","7175318945","ctseng@pennstatehealth.psu.edu",{"type":51,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"John Gniady","Associate Professor of Otolaryngology","100656813","phase-1-single-dose-4-aminopyridine-for-diagnosing-recurrent-laryngeal-nerve-paralysis-continuity-after-trauma-100656813",false,"NCT07832331","Single Dose 4-Aminopyridine for Diagnosing Recurrent Laryngeal Nerve Paralysis Continuity After Trauma","Inclusion Criteria:\n\n* Recurrent Laryngeal Nerve injury (including acute unilateral, and bilateral vocal cord paralysis) following trauma, surgery or intubation\n* Closed soft tissue envelope obscuring direct observation of the continuity of the affected nerve\n* Cognitive ability to report sensory and motor deficit during examination\n* Able to complete single day dosing within 4 months of the inciting event\n* Eligible for standard of care plan of monitoring\n* Adults subject aged 18+\n* Availability for main trial day within 1 week of diagnosis and follow-up visits as needed\n\nExclusion Criteria:\n\n* History of multiple sclerosis, stroke or any other diagnosed neurological or central nervous system disorder or injury\n* History of intercranial surgery\n* History of hypersensitivity to AMPYRA® or 4-aminopyridine\n* Current use of aminopyridine medications, including other compounded 4-AP, e.g. fampridine, dalfampridine\n* Patients with known history of renal impairment (calculated GFR (GFR\\\u003C80 mL\u002Fmin)) within 6 months time\n* Patients with a known history of a seizure disorder (4-AP overdose can, in selected cases, result in limited seizure activity).\n* Patients unable to communicate return or loss of sensation.\n* Patients with injuries too extensive to isolate a single nerve(s) for testing.\n* Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, e.g. Cimetidine, dolutegravir, isavuconazole, ranolazine.\n* Patients who had a direct transection or sacrifice of the nerve\n* Patients who are pregnant\n* History of direct laryngeal trauma\n* Intolerance of exam or study procedures\n* Inability to visualize the larynx upon scope exam\n* Procedural or other pharmacological treatments of RLN paralysis prior to enrollment","ALL","18 Years",{"count":70,"type":71},50,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","This study aims to evaluate the role of single-dose 4-aminopyridine on the diagnosis of recurrent laryngeal nerve (RLN) paralysis. In addition, the investigational treatment will be used to test the hypothesis that 4-aminopyridine can speed the determination of nerve continuity after RLN injuries.",[77,78],"Vocal Cord Paralysis","Recurrent Laryngeal Nerve Palsy",[80,81],"vocal cord paralysis","recurrent laryngeal nerve palsy","NOT_YET_RECRUITING","2026-09-16",{"date":85,"type":86},"2026-09-21","ACTUAL",{"date":88,"type":71},"2026-12-01",{"date":90,"type":71},"2027-12-01",{"name":5,"class":6}]