Phase 2
N=22
DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia
Adductor Spasmodic Dysphonia · Voice Disorders · Spasmodic Dysphonia
Bottom Line
View on ClinicalTrials.gov: NCT05158166 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Our Primary Outcome is the Difference in VHI-10 Score at 30 Days After Injection With DAXI. — 17.81 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DaxibotulinumtoxinA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Our Primary Outcome is the Difference in VHI-10 Score at 30 Days After Injection With DAXI. |
17.81 | <0.001 sig |
| SECONDARY A Secondary Outcome Will be Comparing the Duration of Effect of DAXI With Patients' Prior Botox Treatment. |
130.6; 86.1; 86.86; 83.29; 49.8; 81.8 | 0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- greater than 18
- diagnosis of adductor spasmodic dysphonia
- previous successful treatment with BotoxA
- stabilized dose for last 3 treatments
Exclusion Criteria
- age less than 18
- exclusively having other neurologic conditions such as:
- abductor spasmodic dysphonia
- ALS
- Multiple sclerosis
- Parkinson's disease
- Essential tremor
Data sourced from ClinicalTrials.gov (NCT05158166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.