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Trial record 2 of 13 for:    Recruiting, Not yet recruiting Studies | Spasmodic Dysphonia | United States
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DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia

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ClinicalTrials.gov Identifier: NCT05158166
Recruitment Status : Recruiting
First Posted : December 15, 2021
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.


Condition or disease Intervention/treatment Phase
Adductor Spasmodic Dysphonia Voice Disorders Spasmodic Dysphonia Drug: DaxibotulinumtoxinA Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia
Actual Study Start Date : October 13, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: DaxibotulinumtoxinA
This is a long-acting alternative to traditional Botox A treatment.
Other Name: DAXI


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. A secondary outcome will be comparing the duration of effect of DAXI with patients' prior Botox treatment. [ Time Frame: Up to 1 year ]
    Specifically, we will determine the median time to baseline VHI-10 after treatment with DAXI and produce a Kaplan-Meier curve to illustrate the duration of clinical benefit.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05158166


Locations
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United States, California
UCSF Recruiting
San Francisco, California, United States, 94118
Contact: Clark Rosen, MD    415-885-7700    clark.rosen@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Clark Rosen, MD University of California, San Francisco
More Information
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Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05158166    
Other Study ID Numbers: 21-33778
First Posted: December 15, 2021    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, San Francisco:
adductor spasmodic dysphonia
Additional relevant MeSH terms:
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Dysphonia
Hoarseness
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
 Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents