Zinc + Botox for Spasmodic Dysphonia
What You Need to Know Before You Apply
What is the purpose of this trial?
One initial study has shown that Botulinum Toxin (BT) in combination with zinc supplementation may increase the duration of effects BT treatment. This initial study was in the context of facial aesthetics. The purpose of the present study is to determine the effect, if any, of oral zinc supplementation prior to BT in the treatment of spasmodic dysphonia. If positive effects will be observed, this would help reduce the burden of disease for these patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are taking more than 30 mg of zinc supplements daily, you cannot participate in the study.
Is the combination of Zinc and Botox safe for treating spasmodic dysphonia?
How is the Zinc + Botox drug for spasmodic dysphonia different from other drugs?
The Zinc + Botox treatment for spasmodic dysphonia is unique because it combines botulinum toxin type A with a zinc supplement, which may enhance the effectiveness of the botulinum toxin. This combination is different from other treatments that typically use botulinum toxin alone, and it may offer a novel approach to improving voice symptoms in patients.678910
What data supports the effectiveness of the drug Botulinum toxin type A for treating spasmodic dysphonia?
Research shows that Botulinum toxin injections are effective in improving voice-related quality of life for patients with spasmodic dysphonia, with most experiencing improvement for weeks to months after treatment. Additionally, combining Botulinum toxin with voice therapy can enhance and prolong the benefits.911121314
Who Is on the Research Team?
Neil Chheda
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
Adults over 18 with a current diagnosis of ADductor spasmodic dysphonia, who have been treated with Botox injections for more than 6 months can join. Pregnant individuals or those already taking over 30 mg of zinc daily are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Cycle 1
Participants receive Botulinum toxin A injection into vocal cords with or without zinc supplementation
Follow-up Cycle 1
Participants are monitored for changes in voice-related quality of life and audiometric data
Treatment Cycle 2
Participants receive a second cycle of Botulinum toxin A injection into vocal cords with or without zinc supplementation
Follow-up Cycle 2
Participants are monitored for changes in voice-related quality of life and audiometric data
What Are the Treatments Tested in This Trial?
Interventions
- Botulinum toxin type A
- Zinc gluconate supplement
Botulinum toxin type A is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor