Single Dose 4-Aminopyridine for Diagnosing Recurrent Laryngeal Nerve Paralysis Continuity After Trauma

Inclusion Criteria:

• Recurrent Laryngeal Nerve injury (including acute unilateral, and bilateral vocal cord paralysis) following trauma, surgery or intubation
• Closed soft tissue envelope obscuring direct observation of the continuity of the affected nerve
• Cognitive ability to report sensory and motor deficit during examination
• Able to complete single day dosing within 4 months of the inciting event
• Eligible for standard of care plan of monitoring
• Adults subject aged 18+
• Availability for main trial day within 1 week of diagnosis and follow-up visits as needed

Exclusion Criteria:

• History of multiple sclerosis, stroke or any other diagnosed neurological or central nervous system disorder or injury
• History of intercranial surgery
• History of hypersensitivity to AMPYRA® or 4-aminopyridine
• Current use of aminopyridine medications, including other compounded 4-AP, e.g. fampridine, dalfampridine
• Patients with known history of renal impairment (calculated GFR (GFR<80 mL/min)) within 6 months time
• Patients with a known history of a seizure disorder (4-AP overdose can, in selected cases, result in limited seizure activity).
• Patients unable to communicate return or loss of sensation.
• Patients with injuries too extensive to isolate a single nerve(s) for testing.
• Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, e.g. Cimetidine, dolutegravir, isavuconazole, ranolazine.
• Patients who had a direct transection or sacrifice of the nerve
• Patients who are pregnant
• History of direct laryngeal trauma
• Intolerance of exam or study procedures
• Inability to visualize the larynx upon scope exam
• Procedural or other pharmacological treatments of RLN paralysis prior to enrollment