Trials / Unknown
UnknownNCT05110417
Reversal of Botulinum Neurotoxin Injection Related Dysphonia With Pyridostigmine
Pilot Study of the Efficacy of Pyridostigmine for Reversal of Post Injection Dysphonia Following Botulinum Neurotoxin Laryngeal Chemo-Denervation in Spasmodic Dysphonia
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Eastern Virginia Medical School · Academic / Other
- Sex
- All
- Age
- 21 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pyridostigmine Bromide 60 Milligrams (mg) | One tablet will be provided to patients during the second visit. |
Timeline
- Start date
- 2021-05-20
- Primary completion
- 2022-12-31
- Completion
- 2023-06-01
- First posted
- 2021-11-08
- Last updated
- 2022-07-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05110417. Inclusion in this directory is not an endorsement.