Single Dose 4-Aminopyridine for Diagnosing Recurrent Laryngeal Nerve Paralysis Continuity After Trauma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilton S. Hershey Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
4-Aminopyridine
DrugSubjects will receive one dose of oral dalfampridine 10 mg extended release tablets at start of study day prior to initial flexible laryngoscopy exam.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: 4-Aminopyridine DoseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 hoursSecondary outcomes
1
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 hours2
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 hours3
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 hoursLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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