Recruiting

Pyridostigmine

Sponsor:

Eastern Virginia Medical School

Code:

NCT05110417

Conditions

Dysphonia, Spastic

Dysphonia

Laryngeal Dystonia

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Pyridostigmine Bromide 60 Milligrams (mg)

Study Details

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

Study ID

NCT05110417

Start date

May 20, 2021

Status verified date

Jul, 2022

Completion date

Jun 1, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pyridostigmine (Mestinon)

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

Interventions

Pyridostigmine Bromide 60 Milligrams (mg)

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

Primary outcome measure

  • Rainbow Passage Reading Pre- and Post-Pyridostigmine (Mestinon) [ Time Frame: 15 Minutes ]
  • CAPE-V Pre- and Post-Pyridostigmine (Mestinon) [ Time Frame: 15 Minutes ]
  • Glottal Function Index Pre- and Post-Pyridostigmine (Mestinon) [ Time Frame: 15 Minutes ]
  • Adapted Borg Scale Pre- and Post-Pyridostigmine (Mestinon) [ Time Frame: 15 Minutes ]

Central Contacts and Locations

Central contacts

Addy Tham, MS

757.388.6264thama@evms.edu

Laura Stone, RN

757.388.6238stonelj@evms.edu

Locations

Eastern Virginia Medical School Ear, Nose, and Throat Surgeons

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Addy Tham, MS

757-388-6264thama@evms.edu

Laura Stone, RN

757.388.6238stonelj@evms.edu

Principal Investigator:

Benjamin Rubinstein, MD

More Information

Sponsor

Eastern Virginia Medical School

Last update posted

Jul 27, 2022

Last verified

Jul, 2022

Keywords

  • pyridostigmine
  • dysphonia
  • spasmodic dysphonia
  • Mestinon
  • botulinum neurotoxin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eastern Virginia Medical School on 2022-07-27.