UnknownPhase 4

Reversal of Botulinum Neurotoxin Injection Related Dysphonia With Pyridostigmine

United States10 participantsStarted 2021-05-20

Plain-language 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.

Who can participate

Age range21 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rainbow Passage Reading Pre- and Post-Pyridostigmine (Mestinon)

Timeframe: 15 Minutes

CAPE-V Pre- and Post-Pyridostigmine (Mestinon)

Timeframe: 15 Minutes

Glottal Function Index Pre- and Post-Pyridostigmine (Mestinon)

Timeframe: 15 Minutes

Adapted Borg Scale Pre- and Post-Pyridostigmine (Mestinon)

Timeframe: 15 Minutes

Trial details

NCT IDNCT05110417

SponsorEastern Virginia Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

Contact for this trial

Addy Tham, MS

757.388.6264 thama@evms.edu

View on ClinicalTrials.gov More Dysphonia, Spastic trials