CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
DaxibotulinumtoxinAdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05158166
NCT05158166Phase 2Completed

DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia

University of California, San Francisco·interventional·Posted Dec 15, 2021·Updated May 18, 2026

In Brief

A Phase 2 clinical trial evaluating DaxibotulinumtoxinA for Adductor Spasmodic Dysphonia and 2 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedDec 15, 2021
Enrollment StartOct 13, 2023
Primary CompletionMar 1, 2025
Study CompletionMar 2, 2025
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.5 years ago

Interventions

DaxibotulinumtoxinAdrug

This is a long-acting alternative to traditional Botox A treatment.