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COMPLETED Phase 2

Firdapse for Post-BOTOX Vocal Weakness

NCT05123053 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Amifampridine

Study Locations (1)

Georgia

  • Augusta University — Augusta

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2021-10-28
Est. Completion 2025-09-23
Phase Phase 2

Sponsor

Augusta University

126 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05123053

The ClinicalTrials.gov registry entry for NCT05123053 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 126 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05123053 reports 1 study location spanning 1 distinct geographic area — top geographies include Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05123053?

The interventions under investigation include: Amifampridine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05123053?

This trial is sponsored by Augusta University, which has 126 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial