← Back to Search

Procedure

Zinc + Botox for Spasmodic Dysphonia

Phase 1 & 2

Waitlist Available

Led By Neil Chheda

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current diagnosis of ADductor spasmodic dysphonia

Has had Botox injection treatments for SD > 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the patient record their voice on post-injection day 2, 7, 14, 42, 70, and 98. at their next botox injection, a second cycle will immediately begin for an additional 3 months with audio data obtained on post injection day 2, 7, 14, 42, 70, and 98

Awards & highlights

Study Summary

This trial is studying if combining Botulinum Toxin (BT) treatment with zinc supplementation can improve the effects of BT for spasmodic dysphonia patients.

Who is the study for?

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.Check my eligibility

What is being tested?

The study is testing if taking a zinc gluconate supplement before getting Botulinum toxin type A (Botox) injections helps extend the treatment's benefits for voice hoarseness due to spasmodic dysphonia.See study design

What are the potential side effects?

Possible side effects may include reactions at the injection site, muscle weakness, difficulty swallowing, and flu-like symptoms from Botox; nausea, vomiting, and metallic taste from zinc supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with ADductor spasmodic dysphonia.

Select...

I have received Botox treatments for my condition for over 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the patient record their voice on post-injection day 2, 7, 14, 42, 70, and 98. at their next botox injection, a second cycle will immediately begin for an additional 3 months with audio data obtained on post injection day 2, 7, 14, 42, 70, and 98

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the patient record their voice on post-injection day 2, 7, 14, 42, 70, and 98. at their next botox injection, a second cycle will immediately begin for an additional 3 months with audio data obtained on post injection day 2, 7, 14, 42, 70, and 98

This trial's timeline: 3 weeks for screening, Varies for treatment, and the patient record their voice on post-injection day 2, 7, 14, 42, 70, and 98. at their next botox injection, a second cycle will immediately begin for an additional 3 months with audio data obtained on post injection day 2, 7, 14, 42, 70, and 98 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in audiometric recording data of subject's speech during a laryngeal botox injection cycle.

Change of Voice-Related Quality of Life (V-RQOL) questionnaire scores during a laryngeal botox injection cycle.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Botulinum toxin A injection +zinc supplementation"Experimental Treatment2 Interventions

Botulinum toxin A injection into vocal cords for treatment of spasmodic dysphonia, with subject taking zinc supplementation daily for the 5 days preceding the botox injection. This will be the experimental arm of the study.

Group II: Botulinum toxin A injectionActive Control1 Intervention

Botulinum toxin A injection into vocal cords for treatment of spasmodic dysphonia. This is the current standard of care for treatment of this disease process. This will be the control of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zinc gluconate supplement

2016

Completed Phase 2

~70

Botulinum toxin type A

2011

Completed Phase 4

~2730

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,660 Total Patients Enrolled

Neil ChhedaPrincipal InvestigatorUniversity of Florida

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to geriatric participants?

"To be eligible for this study, one must fit the age range of 18 to 99. For those under 18 and beyond 65 years old, there are 3 trials and 24 respectively that may suit their needs better."

Answered by AI

Are there any openings for patient participation in this clinical trial at the present time?

"According to the clinicaltrials.gov listing, this medical trial is not currently recruiting candidates for participation. The posting was initially published on August 1st 2023 and last updated September 14th of that same year. Although no longer seeking enrollees, there are 25 other trials in progress which require volunteers at present."

Answered by AI

Who has the requirements to be admitted into this research program?

"This medical trial is looking for 36 individuals aged 18-99 who are presently suffering from spasmodic dysphonia. To be eligible, participants must meet the following criteria: adults above legal age, an existing diagnosis of ADductor spasmodic dysphonia and at least 6 months of Botox treatment for SD."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia

2023. "Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05892770.