Reversal of Botulinum Neurotoxin Injection Related Dysphonia With Pyridostigmine

Eastern Virginia Medical School (EVMS)

Status and phase: Enrolling; Phase 4

Conditions: Dysphonia, Spastic; Laryngeal Dystonia; Dysphonia

Treatments: Drug: Pyridostigmine Bromide 60 Milligrams (mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT05110417

V4.0 28July2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Pyridostigmine (Mestinon)

Experimental group

Description:

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

Treatment:

Drug: Pyridostigmine Bromide 60 Milligrams (mg)