Reversal of Botulinum Neurotoxin Injection Related Dysphonia With Pyridostigmine

NCT05110417 | Unknown Phase 4 FDA Drug

• 1 other identifier: V4.0 28July2021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphonia, Spastic; Dysphonia; Laryngeal Dystonia

Keywords

pyridostigmine; dysphonia; spasmodic dysphonia; Mestinon; botulinum neurotoxin

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Pyridostigmine (Mestinon)

EXPERIMENTAL

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

Drug: Pyridostigmine Bromide 60 Milligrams (mg)

Interventions

Pyridostigmine Bromide 60 Milligrams (mg) DRUG

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

Also known as: Amneal Pharmaceuticals Pvt. Ltd., Serial Number: 1000462308

Pyridostigmine (Mestinon)

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eastern Virginia Medical School: lead

Study Sites (1)

Eastern Virginia Medical School Ear, Nose, and Throat Surgeons

Norfolk, Virginia, 23507, United States

RECRUITING

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin Rubinstein, MD

  Eastern Virginia Medical School Department of Otolaryngology - Head and Neck Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Addy Tham, MS

CONTACT

757.388.6264; thama@evms.edu

Laura Stone, RN

CONTACT

757.388.6238; stonelj@evms.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: November 8, 2021
• Study Start: May 20, 2021
• Primary Completion: December 31, 2022
• Study Completion: June 1, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

US (1)