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Firdapse for Post-BOTOX Vocal Weakness

NCT05123053 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-10-03

No results posted yet for this study

Summary

Botox injections into the thyroarytenoid muscle are a predictable and effective treatment for SD, but typically result in transient symptoms of voice weakness and breathiness during the first 2-3 weeks after injection. Investigators hypothesize that voice weakness and breathiness after Botox treatment can be alleviated using amifampridine.

Conditions

  • Vocal Weakness(Post-BOTOX Injection)

Interventions

DRUG

Amifampridine

10mg tablet

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Michael H Rivner, MD · Charbonnier Professor Emeritus of Neurology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2025-05-27
Completion
2025-09-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05123053 on ClinicalTrials.gov