DaxibotulinumtoxinA Injection for Spasmodic Dysphonia
Trial Summary
What is the purpose of this trial?
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.
Research Team
Clark Rosen, MD
Principal Investigator
University of California, San Francisco
Eligibility Criteria
This trial is for adults with adductor spasmodic dysphonia, a voice disorder causing muscle contractions that affect speech. Participants must have had successful previous treatments with Botox and maintained a stable dose in their last three treatments. It's not open to individuals under 18 or those with certain neurological conditions like ALS, multiple sclerosis, Parkinson's disease, or essential tremor.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DAXI injections for treatment of adductor spasmodic dysphonia
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- DaxibotulinumtoxinA Injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor