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Clinical Trials/NCT05158166
NCT05158166
Completed
Phase 1

DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia

University of California, San Francisco1 site in 1 country22 target enrollmentOctober 13, 2023

Overview

Phase
Phase 1
Intervention
DaxibotulinumtoxinA
Conditions
Adductor Spasmodic Dysphonia
Sponsor
University of California, San Francisco
Enrollment
22
Locations
1
Primary Endpoint
Our primary outcome is the difference in VHI-10 score at 6 weeks after injection with DAXI.
Status
Completed
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 13, 2023
End Date
March 2, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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
  • Multiple sclerosis
  • Parkinson's disease
  • Essential tremor

Arms & Interventions

Administration of Daxi

Injectible daxibotulinumtoxinA (DAXI, Revance Therapeutics Inc., Newark, CA) is an investigational botulinum toxin type A which has been shown in large clinical trials to provide safe, effective treatment for glabellar lines and cervical dystonia and may offer longer-lasting results when compared with onabotulinumtoxinA. Dosage will be same number of units as prior Botox A dose.

Intervention: DaxibotulinumtoxinA

Outcomes

Primary Outcomes

Our primary outcome is the difference in VHI-10 score at 6 weeks after injection with DAXI.

Time Frame: 6 weeks

This will be determined using a paired t-test with subjects pre-treatment VHI-10 scores as a control.

Secondary Outcomes

  • A secondary outcome will be comparing the duration of effect of DAXI with patients' prior Botox treatment.(Up to 1 year)

Study Sites (1)

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