DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Voice Disorders; Spasmodic Dysphonia; Adductor Spasmodic Dysphonia

Treatments: Drug: DaxibotulinumtoxinA

Study type: Interventional

Funder types: Other

Identifiers

NCT05158166

21-33778

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Administration of Daxi

Experimental group

Description:

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.

Treatment:

Drug: DaxibotulinumtoxinA