Can a single pill reveal if damaged vocal cord nerves still work?
NCT ID NCT07832331
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
This trial tests whether a single dose of 4-aminopyridine (dalfampridine) can help diagnose recurrent laryngeal nerve paralysis after trauma, surgery, or intubation. Adults with recent nerve injury receive one oral dose before a flexible laryngoscopy exam. Doctors then check for improved vocal cord motion and changes in voice and swallowing. The goal is to see if the drug can speed up the determination of nerve continuity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 4-aminopyridine (dalfampridine)
- What this could lead to
- If it works, this could give doctors a faster way to tell whether a damaged vocal cord nerve is still connected, which may guide treatment decisions sooner.
- What could go wrong
- This is a small Phase 1 trial, so it may not show a clear benefit. The drug can cause side effects like dizziness or tingling, and the results may not apply to all nerve injuries.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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