A Phase 1 interventional study of 4-Aminopyridine in Vocal Cord Paralysis and Recurrent Laryngeal Nerve Palsy, sponsored by Milton S. Hershey Medical Center. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Milton S. Hershey Medical Center · Phase 1, Interventional, and Diagnostic
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.
61 studies on the registry are indexed under Vocal Cord Paralysis; 16 are open to participants now.
This study's planned enrollment of 50 is above the median of 39 across 43 interventional studies indexed under Vocal Cord Paralysis.
Browse Vocal Cord Paralysis studies →Milton S. Hershey Medical Center is the lead sponsor of 492 studies on the registry; 60 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Also known as: dalfampridine, Ampyra
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.
Time frame: 3 hours
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.
Time frame: baseline to 3 hours
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.
Time frame: baseline to 3 hours
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.
Time frame: baseline to 3 hours
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: 4-Aminopyridine
Milton S. Hershey Medical Center →