Reversal of Botulinum Neurotoxin Injection Related Dysphonia With Pyridostigmine

Phase 4

• Conditions: Dysphonia; Laryngeal Dystonia; Dysphonia, Spastic
• Interventions: Drug: Pyridostigmine Bromide 60 Milligrams (mg)

• Registration Number: NCT05110417
• Lead Sponsor: Eastern Virginia Medical School

Brief 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.

Detailed 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 Timeline

• Study Start: 2021-05-20
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-27
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Males and Females Aged 21-100
• Scheduled for Botulinum Neurotoxin (BoNT) Treatment for Spasmodic Dysphonia (SD)

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Exclusion Criteria

• Subjects who are Pregnant or Lactating
• Subjects with Compromised Renal or Cardiac Function
• Subjects with Spasmodic Dysphonia with Superimposed Vocal Tremor

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pyridostigmine (Mestinon)	Pyridostigmine Bromide 60 Milligrams (mg)	Pyridostigmine (Mestinon) will be assigned to patients in this arm.

Primary Outcome Measures

Name	Time	Method
Glottal Function Index Pre- and Post-Pyridostigmine (Mestinon)	15 Minutes	This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another primary outcome measure being assessed is the glottal function index (GFI). A comparison between the pre-pyridostigmine GFI and post-pyridostigmine GFI will be performed to meet this outcome measure. Score is ranked from 0 to 5. The lower the GFI score indicates fewer problems/effort.
Adapted Borg Scale Pre- and Post-Pyridostigmine (Mestinon)	15 Minutes	This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another primary outcome measure being assessed is the adapted Borg scale. A comparison between the pre-pyridostigmine scale rating and the post-pyridostigmine scale rating will be performed to meet this outcome measure. The scale is ranked from 0 to 10. The higher the number indicates more effort in the tasks while a lower number indicates less effort.
Rainbow Passage Reading Pre- and Post-Pyridostigmine (Mestinon)	15 Minutes	This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. One of the outcome measures used will be the Rainbow Passage reading. A comparison between pre-pyridostigmine reading and post-pyridostigmine reading will be performed to meet this outcome measure.
CAPE-V Pre- and Post-Pyridostigmine (Mestinon)	15 Minutes	This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another outcome measurement used will be the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V). A comparison between the pre-pyridostigmine evaluation of the CAPE-V and post-pyridostigmine evaluation of the CAPE-V will be performed to meet this outcome measure.

Trial Locations

Locations (1)

Eastern Virginia Medical School Ear, Nose, and Throat Surgeons; 🇺🇸 Norfolk, Virginia, United States