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NCT05123053 · ClinicalTrials.gov registry record · Phase 2
Firdapse for Post-BOTOX Vocal Weakness
A Phase 2 study of Vocal Weakness(Post-BOTOX Injection), sponsored by Augusta University.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05123053: Completed Phase 2 study of Vocal Weakness(Post-BOTOX Injection), sponsored by Augusta University.
NCT05123053 is a Phase 2 study of Vocal Weakness(Post-BOTOX Injection) that has completed, run by Augusta University. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05123053, a Phase 2 study of Vocal Weakness(Post-BOTOX Injection), has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
VHI-10 is a scale used to assess the severity of problematic symptoms associated with the voice. It is a series of 10 questions. Each questions is answered using numbers 0-4, with 0 meaning the patient never has a problem with that symptom; and, 4 meaning the patient always has a problem with that symptom.
Conditions Studied
Interventions
- DRUG Amifampridine
Study Locations (1)
Georgia
- Augusta University - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-10-28 |
| Est. Completion | 2025-09-23 |
| Phase | Phase 2 |
What the finished NCT05123053 record still lists
NCT05123053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Vocal Weakness(Post-BOTOX Injection) appearing as the primary indexed condition, and to 1 intervention - of which Amifampridine is the first listed.
NCT05123053 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05123053 about?
NCT05123053 is a clinical study titled "Firdapse for Post-BOTOX Vocal Weakness". 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 treatme...
What is the current status of trial NCT05123053?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2021-10-28. Estimated completion is 2025-09-23.
What conditions does trial NCT05123053 study?
This clinical trial studies the following conditions: Vocal Weakness(Post-BOTOX Injection).
What interventions are being tested in trial NCT05123053?
The interventions under investigation include: Amifampridine (DRUG).
Who is sponsoring clinical trial NCT05123053?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05123053 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05123053's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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