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NCT05158166 · ClinicalTrials.gov registry record · Phase 1
DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT05158166: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT05158166 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05158166, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Spasmodic Dysphonia (SD) is a neurologic condition causing inappropriate contraction of the laryngeal musculature, leading to abnormal voicing. The three types (adductor, abductor, and mixed) affect varying muscle groups which produce characteristic voice patterns. The vast majority of patients with SD have adductor type, which impacts the lateral cricoarytenoid and thyroarytenoid muscle complex. While many treatment modalities have been investigated, the most effective treatment is botulinum toxin injection to these muscle groups, performed transcervically with or without electromyography (EMG) guidance. Patients undergoing this treatment typically require re-injection every 3 months. Due to its specialized nature, the laryngeal injections are not performed routinely outside of academic medical centers; thus, patients may come from a distance to receive this treatment. Both due to the significant impact on voice quality when the injections wear off and the sometimes challenging access to treatment, a longer-acting agent is desired. Injectible daxibotuliumtoxinA (DAXI, Revance Therapeutics Inc., Newark, CA) has been shown in large clinical trials to provide safe, effective treatment for glabellar lines and cervical dystonia and may offer a longer-lasting result when compared with onabotulinumtoxinA. Thus, a study examining the effect of DAXI for patients with adductor spasmodic dysphonia is proposed. This study aims to assess the efficacy of DAXI for transcervical laryngeal injection in patients with adductor spasmodic dysphonia.
Primary Outcome
The Voice Handicap Index-10 (VHI-10) is a patient-reported questionnaire (range 0-40) that measures voice-related handicap, with higher scores indicating greater severity. Difference between baseline and 30 days post DAXI injection scores will be determined using a paired t-test with subjects pre-treatment VHI-10 scores as a control.
Interventions
- DRUG DaxibotulinumtoxinA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2023-10-13 |
| Est. Completion | 2025-03-02 |
| Phase | Phase 1 |
What the finished NCT05158166 record still lists
NCT05158166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which DaxibotulinumtoxinA is the first listed.
NCT05158166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05158166 about?
NCT05158166 is a clinical study titled "DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia". Spasmodic Dysphonia (SD) is a neurologic condition causing inappropriate contraction of the laryngeal musculature, leading to abnormal voicing. The three types (adductor, abductor, and mixed) affect varying muscle groups which produce characteristic voice patterns. The vast majority of patients with...
What is the current status of trial NCT05158166?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2023-10-13. Estimated completion is 2025-03-02.
What interventions are being tested in trial NCT05158166?
The interventions under investigation include: DaxibotulinumtoxinA (DRUG).
Who is sponsoring clinical trial NCT05158166?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05158166's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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