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Reversal of Botulinum Neurotoxin Injection Related Dysphonia With Pyridostigmine

Dysphonia Clinical Trial

Official title:
Pilot Study of the Efficacy of Pyridostigmine for Reversal of Post Injection Dysphonia Following Botulinum Neurotoxin Laryngeal Chemo-Denervation in Spasmodic Dysphonia

Clinical Trial Summary

The purpose of this study is to evaluate the effects of pyridostigmine (Mestinon) on patient vocal outcomes after undergoing laryngeal botulinum neurotoxin (BoNT) injections, which is a standard treatment for spasmodic dysphonia. Pyridostigmine (Mestinon) has been used for treatment of BoNT overdose, and it is our hope that it will be beneficial in the management of post BoNT breathy phase.

Clinical Trial Description

The study will enroll 10 subjects and will involve 1 clinic visit with two sessions over 2 hours. Participants' voices will then be analyzed via sentence/passage reading, sustained vowel holding, maximum phonation time, as well as subjective ratings of effort. During the second clinic visit, participants will then be administered one 60mg tablet of pyridostigmine (Mestinon) orally, and asked to return to the clinic in 2 hours, when Mestinon has reached peak plasma concentration. Upon returning, participants will repeat the vocal analysis and results will be evaluated for any change in outcome. Patients who are pregnant, lactating, or have kidney or heart disease should not participate. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05110417
Study type Interventional
Source Eastern Virginia Medical School
Contact Addy Tham, MS
Phone 757.388.6264
Email thama@evms.edu
Status Recruiting
Phase Phase 4
Start date May 20, 2021
Completion date June 1, 2023
View Details
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