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Cholinesterase Inhibitor

Reversal of Botulinum Neurotoxin Injection Related Dysphonia With Pyridostigmine

Phase 4
Waitlist Available
Led By Benjamin Rubinstein, MD
Research Sponsored by Eastern Virginia Medical School
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests if pyridostigmine can improve voice quality in patients with spasmodic dysphonia who have a breathy voice after their usual treatment. The medication helps muscles work better, which might enhance their voice.

Eligible Conditions
  • Hoarseness
  • Voice Disorder
  • Spasmodic Dysphonia
  • Spastic dysphonia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adapted Borg Scale Pre- and Post-Pyridostigmine (Mestinon)
CAPE-V Pre- and Post-Pyridostigmine (Mestinon)
Glottal Function Index Pre- and Post-Pyridostigmine (Mestinon)
+1 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pyridostigmine (Mestinon)Experimental Treatment1 Intervention
Pyridostigmine (Mestinon) will be assigned to patients in this arm.

Find a Location

Who is running the clinical trial?

Eastern Virginia Medical SchoolLead Sponsor
74 Previous Clinical Trials
16,021 Total Patients Enrolled
Benjamin Rubinstein, MDPrincipal InvestigatorEastern Virginia Medical School Department of Otolaryngology - Head and Neck Surgery
1 Previous Clinical Trials
40 Total Patients Enrolled
~2 spots leftby Dec 2025
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