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Pilot Study of the Efficacy of Pyridostigmine for Reversal of Post Injection Dysphonia Following Botulinum Neurotoxin Laryngeal Chemo-Denervation in Spasmodic Dysphonia
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.
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.
Age
21 - 100 years
Sex
ALL
Healthy Volunteers
No
Eastern Virginia Medical School Ear, Nose, and Throat Surgeons
Norfolk, Virginia, United States
Start Date
May 20, 2021
Primary Completion Date
December 31, 2022
Completion Date
June 1, 2023
Last Updated
July 27, 2022
10
ESTIMATED participants
Pyridostigmine Bromide 60 Milligrams (mg)
DRUG
Lead Sponsor
Eastern Virginia Medical School
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05970562