Reversal of Botulinum Neurotoxin Injection Related Dysphonia With Pyridostigmine

Sponsor

Eastern Virginia Medical School (Other)

Overall Status

Recruiting

CT.gov ID

NCT05110417

Collaborator

(none)

Enrollment

Location

Arm

24.4

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dysphonia, Spastic Dysphonia Laryngeal Dystonia	Drug: Pyridostigmine Bromide 60 Milligrams (mg)	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a pilot study so all 10 participants will be assigned to the pyridostigmine (Mestinon) treatment arm.This is a pilot study so all 10 participants will be assigned to the pyridostigmine (Mestinon) treatment arm.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 20, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pyridostigmine (Mestinon) Pyridostigmine (Mestinon) will be assigned to patients in this arm.	Drug: Pyridostigmine Bromide 60 Milligrams (mg) One tablet will be provided to patients during the second visit. Other Names: Amneal Pharmaceuticals Pvt. Ltd. Serial Number: 1000462308

Arm

Intervention/Treatment

Experimental: Pyridostigmine (Mestinon)

Pyridostigmine (Mestinon) will be assigned to patients in this arm.

Drug: Pyridostigmine Bromide 60 Milligrams (mg)

One tablet will be provided to patients during the second visit.

Other Names:

Amneal Pharmaceuticals Pvt. Ltd.

Serial Number: 1000462308

Outcome Measures

Primary Outcome Measures

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.
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.