Reversal of Botulinum Neurotoxin Injection Related Dysphonia With Pyridostigmine

July 25, 2022 updated by: Benjamin J Rubinstein, Eastern Virginia Medical School

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Eastern Virginia Medical School Ear, Nose, and Throat Surgeons
        • Sub-Investigator:
          • Anne Michalek, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rainbow Passage Reading Pre- and Post-Pyridostigmine (Mestinon)
Time Frame: 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.
15 Minutes
CAPE-V Pre- and Post-Pyridostigmine (Mestinon)
Time Frame: 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.
15 Minutes
Glottal Function Index Pre- and Post-Pyridostigmine (Mestinon)
Time Frame: 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.
15 Minutes
Adapted Borg Scale Pre- and Post-Pyridostigmine (Mestinon)
Time Frame: 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.
15 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Virginia Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V4.0 28July2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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