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Botulinum Toxin
DaxibotulinumtoxinA Injection for Spasmodic Dysphonia
Phase 1 & 2
Recruiting
Led By Clark Rosen, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stabilized dose for last 3 treatments
Diagnosis of adductor spasmodic dysphonia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial looks at an injectible drug for a neurologic condition causing abnormal voicing, to assess longer-lasting results.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests DaxibotulinumtoxinA injections as a treatment for adductor spasmodic dysphonia. This condition affects the muscles responsible for voice control. The goal is to see if this new treatment can improve voice quality longer than current options like onabotulinumtoxinA (Botox).See study design
What are the potential side effects?
While not specified here, botulinum toxin injections can generally cause side effects such as pain at the injection site, flu-like symptoms, headache, respiratory infection, temporary voice weakness or breathiness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My medication dose has been the same for my last 3 treatments.
Select...
I have been diagnosed with adductor spasmodic dysphonia.
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I have had successful treatment with Botox before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Our is the difference in VHI-10 score at 6 weeks after injection with DAXI.
Secondary outcome measures
A will be comparing the duration of effect of DAXI with patients' prior Botox treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Administration of DaxiExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
DaxibotulinumtoxinA
2015
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,507 Previous Clinical Trials
15,238,555 Total Patients Enrolled
2 Trials studying Voice Disorders
70 Patients Enrolled for Voice Disorders
Clark Rosen, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
57 Total Patients Enrolled
1 Trials studying Voice Disorders
57 Patients Enrolled for Voice Disorders
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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