Reversal of Botulinum Neurotoxin Injection Related Dysphonia With Pyridostigmine
NCT ID: NCT05110417
Last Updated: 2022-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
10 participants
INTERVENTIONAL
2021-05-20
2023-06-01
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pyridostigmine (Mestinon)
Pyridostigmine (Mestinon) will be assigned to patients in this arm.
Pyridostigmine Bromide 60 Milligrams (mg)
One tablet will be provided to patients during the second visit.
Interventions
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Pyridostigmine Bromide 60 Milligrams (mg)
One tablet will be provided to patients during the second visit.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for Botulinum Neurotoxin (BoNT) Treatment for Spasmodic Dysphonia (SD)
Exclusion Criteria
* Subjects with Compromised Renal or Cardiac Function
* Subjects with Spasmodic Dysphonia with Superimposed Vocal Tremor
21 Years
100 Years
ALL
No
Sponsors
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Eastern Virginia Medical School
OTHER
Responsible Party
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Benjamin J Rubinstein
Assistant Professor
Principal Investigators
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Benjamin Rubinstein, MD
Role: PRINCIPAL_INVESTIGATOR
Eastern Virginia Medical School Department of Otolaryngology - Head and Neck Surgery
Locations
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Eastern Virginia Medical School Ear, Nose, and Throat Surgeons
Norfolk, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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V4.0 28July2021
Identifier Type: -
Identifier Source: org_study_id
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