A Phase 4 interventional study of Pyridostigmine Bromide 60 Milligrams (mg) in Dysphonia, Spastic, Dysphonia and Laryngeal Dystonia, sponsored by Eastern Virginia Medical School. Status unknown at 1 site in United States. Open to participants aged 21 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-07-27.
Sponsored by Eastern Virginia Medical School · Phase 4, Interventional, and Treatment
Among 71 studies in Dysphonia with a site in United States — 20 open to participants now, 21 under way, 1 of them phase 3. Dysphonia · United States.
Among the 71 studies in Dysphonia with a site in United States, this one is the 46th largest by planned enrollment of the 53 interventional ones, is one of 7 that started in 2021, is one of 5 in phase 4, and was the 44th registered.
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
This study's planned enrollment of 10 is below the median of 30 across 87 interventional studies indexed under Dysphonia.
Browse Dysphonia studies →20 of the 71 studies in Dysphonia with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 25 Dysphonia studies recruiting now, 8 (32%) set no upper age limit and 9 (36%) stop at 75 or younger; 7 take children under 18; 14 take healthy volunteers.
This study: 21 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →71 studies; the count open now beside each. This study's row is marked.
First in 1992; this study’s year is marked. 7 started in 2021.
Median enrollment 32 across the 53 interventional studies, 170 across the 18 observational. Of the 41 that completed or were terminated, 17 (41%) have results posted.
2 of 71 have an industry lead sponsor. The 10 most frequent:
Eastern Virginia Medical School is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Eastern Virginia Medical School has 1 study filed under Dysphonia — fewer than ten, so there is no comparison to draw.
12 of the studies in Dysphonia with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07145086Phase 3Texas Christian UniversityTranslaryngeal Vibration for Hyperfunctional Voice Disorders | 2027-04-30 |
| NCT06830174Yale UniversitytDCS for Laryngeal Dystonia | 2026-12 |
| NCT03702322University of ArizonaImproving Voice Production for Adults With Age-related Dysphonia | 2026-12-30 |
| NCT05095740MGH Institute of Health ProfessionsEffects of Neuromodulation in Laryngeal Dystonia | 2026-12-31 |
| NCT07443891University of MinnesotaBrain Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia | 2027-02-28 |
Among the 71 studies in Dysphonia with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pyridostigmine (Mestinon) will be assigned to patients in this arm.
Drug: Pyridostigmine Bromide 60 Milligrams (mg)
One tablet will be provided to patients during the second visit.
Also known as: Amneal Pharmaceuticals Pvt. Ltd., Serial Number: 1000462308
Rainbow Passage Reading Pre- and Post-Pyridostigmine (Mestinon)
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. One of the outcome measures used will be the Rainbow Passage reading. A comparison between pre-pyridostigmine reading and post-pyridostigmine reading will be performed to meet this outcome measure.
Time frame: 15 Minutes
CAPE-V Pre- and Post-Pyridostigmine (Mestinon)
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another outcome measurement used will be the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V). A comparison between the pre-pyridostigmine evaluation of the CAPE-V and post-pyridostigmine evaluation of the CAPE-V will be performed to meet this outcome measure.
Time frame: 15 Minutes
Glottal Function Index Pre- and Post-Pyridostigmine (Mestinon)
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another primary outcome measure being assessed is the glottal function index (GFI). A comparison between the pre-pyridostigmine GFI and post-pyridostigmine GFI will be performed to meet this outcome measure. Score is ranked from 0 to 5. The lower the GFI score indicates fewer problems/effort.
Time frame: 15 Minutes
Adapted Borg Scale Pre- and Post-Pyridostigmine (Mestinon)
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another primary outcome measure being assessed is the adapted Borg scale. A comparison between the pre-pyridostigmine scale rating and the post-pyridostigmine scale rating will be performed to meet this outcome measure. The scale is ranked from 0 to 10. The higher the number indicates more effort in the tasks while a lower number indicates less effort.
Time frame: 15 Minutes
Started May 2021 (actual). Primary completion is estimated for Dec 2022, 19 months after the start.
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This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Eastern Virginia Medical School