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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05110417
• Other study ID #: V4.0 28July2021
• Status: Recruiting
• Phase: Phase 4
• Start date: May 20, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2022
• Source: Eastern Virginia Medical School
• Contact: Addy Tham, MS
• Phone: 757.388.6264
• Email: thama[@]evms.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

Inclusion Criteria:

• Males and Females Aged 21-100

• Scheduled for Botulinum Neurotoxin (BoNT) Treatment for Spasmodic Dysphonia (SD)

Exclusion Criteria:

• Subjects who are Pregnant or Lactating

• Subjects with Compromised Renal or Cardiac Function

• Subjects with Spasmodic Dysphonia with Superimposed Vocal Tremor

Related Conditions & MeSH terms

• Dysphonia
• Dystonia
• Hoarseness
• Laryngeal Dystonia

Intervention

Drug:
• Pyridostigmine Bromide 60 Milligrams (mg)
One tablet will be provided to patients during the second visit.

Locations

Country	Name	City	State
United States	Eastern Virginia Medical School Ear, Nose, and Throat Surgeons	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Virginia Medical School

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rainbow Passage Reading Pre- and Post-Pyridostigmine (Mestinon)	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.	15 Minutes
Primary	CAPE-V Pre- and Post-Pyridostigmine (Mestinon)	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.	15 Minutes
Primary	Glottal Function Index Pre- and Post-Pyridostigmine (Mestinon)	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.	15 Minutes
Primary	Adapted Borg Scale Pre- and Post-Pyridostigmine (Mestinon)	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.	15 Minutes