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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

Must not have

Diagnosis of ABductor spasmodic dysphonia

Patients taking > 30 mg zinc supplementation daily prior to study beginning

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with ABductor spasmodic dysphonia.

Select...

I have been taking more than 30 mg of zinc daily before starting the study.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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