Vocal Cord ParalysisPhase 1NCT07832331
Single Dose 4-Aminopyridine for Diagnosing Recurrent Laryngeal Nerve Paralysis Continuity After Trauma
A Phase 1 study testing 4-Aminopyridine in people with Vocal Cord Paralysis and Recurrent Laryngeal Nerve Palsy, run by Milton S. Hershey Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vocal Cord Paralysis, Recurrent Laryngeal Nerve Palsy
- What is being tested?
- 4-Aminopyridine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- 4-Aminopyridine
- Keywords
- vocal cord paralysis, recurrent laryngeal nerve palsy
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-AminopyridineDrug
Also called dalfampridine, Ampyra
Subjects will receive one dose of oral dalfampridine 10 mg extended release tablets at start of study day prior to initial flexible laryngoscopy exam.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 4-Aminopyridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 hours
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: baseline to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord ParalysisStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Gniady, Milton S. Hershey Medical Center
- Investigators
- John P Gniady, MD, Principal investigator, Penn State Health Milton S Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832331
- Sponsor's protocol ID
- 28667
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose 4-Aminopyridine for Diagnosing Recurrent Laryngeal Nerve Paralysis Continuity After Trauma
- ClinicalTrials.gov ID
- NCT07832331
- Acronym / sponsor ID
- 28667
- Keywords
- vocal cord paralysis, recurrent laryngeal nerve palsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4-Aminopyridine Dose | Experimental | Drug: 4-AminopyridineSubjects will receive one dose of oral 4-aminopyridine 10 mg extended release tablet at start of study day prior to initial flexible laryngoscopy exam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-AminopyridineAlso: dalfampridine, AmpyraSubjects will receive one dose of oral dalfampridine 10 mg extended release tablets at start of study day prior to initial flexible laryngoscopy exam. | Drug | 4-Aminopyridine Dose |
Primary outcome
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 secondary outcomes
Change in Voice Handicap Index score after receiving 4-aminopyridine
Time frame: baseline to 3 hours
Change in Eating Assessment Tool-10 score after receiving 4-aminopyridine
Time frame: baseline to 3 hours
Change in Reflux Symptom Index score after receiving 4-aminopyridine
Time frame: baseline to 3 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John P Gniady, MD principal investigator
Penn State Health Milton S Hershey Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 4-Aminopyridine in people with Vocal Cord Paralysis and Recurrent Laryngeal Nerve Palsy, run by Milton S. Hershey Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher C Tseng, MD (7175318945, ctseng@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with vocal cord paralysis after receiving 4-aminopyridine (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.