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

September 16, 2026 updated by: John Gniady, Milton S. Hershey Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4-Aminopyridine Dose

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.

Other Names:
  • Ampyra
  • dalfampridine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with vocal cord paralysis after receiving 4-aminopyridine
Time Frame: 3 hours

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Voice Handicap Index score after receiving 4-aminopyridine
Time Frame: baseline to 3 hours

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
Change in Eating Assessment Tool-10 score after receiving 4-aminopyridine
Time Frame: baseline to 3 hours

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.
baseline to 3 hours
Change in Reflux Symptom Index score after receiving 4-aminopyridine
Time Frame: baseline to 3 hours

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.
baseline to 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: John P Gniady, MD, Penn State Health Milton S Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 16, 2026

First Submitted That Met QC Criteria

September 16, 2026

First Posted (Actual)

September 21, 2026

Study Record Updates

Last Update Posted (Actual)

September 21, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28667

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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