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DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia

Sponsor
University of California, San Francisco (Other)
Overall Status
Withdrawn
CT.gov ID
NCT05158166
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
20
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 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
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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 Names:
  • DAXI

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 UCSF San Francisco California United States 94118

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Clark Rosen, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT05158166
    Other Study ID Numbers:
    • 21-33778
    First Posted:
    Dec 15, 2021
    Last Update Posted:
    Mar 17, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Dysphonia
    Hoarseness
    Voice Disorders
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Mar 17, 2022