Zinc + Botox for Spasmodic Dysphonia

Overseen By Carolyn Dirain

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Florida

Must be taking: Botox

Must not be taking: Zinc supplements

Disqualifiers: Pregnant, Abductor spasmodic dysphonia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

36 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

Is the combination of Zinc and Botox safe for treating spasmodic dysphonia?

Studies on Xeomin (a type of Botox) show it is generally safe for conditions like cervical dystonia and blepharospasm, with common side effects like difficulty swallowing. However, there is no specific safety data available for the combination of Zinc and Botox for spasmodic dysphonia. ^{6 7 8 9 10}

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. ^{2 11 12 13 14}

Research Team

Neil Chheda

Principal Investigator

University of Florida

Eligibility Criteria

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

I have been diagnosed with ADductor spasmodic dysphonia.

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

Exclusion Criteria

I have been diagnosed with ABductor spasmodic dysphonia.

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

Pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Cycle 1

Participants receive Botulinum toxin A injection into vocal cords with or without zinc supplementation

14 weeks

6 visits (in-person)

Follow-up Cycle 1

Participants are monitored for changes in voice-related quality of life and audiometric data

14 weeks

6 visits (in-person)

Treatment Cycle 2

Participants receive a second cycle of Botulinum toxin A injection into vocal cords with or without zinc supplementation

14 weeks

6 visits (in-person)

Follow-up Cycle 2

Participants are monitored for changes in voice-related quality of life and audiometric data

14 weeks

6 visits (in-person)

Treatment Details

Interventions

• Botulinum toxin type A
• Zinc gluconate supplement

Trial Overview 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.

Participant Groups

Group I: Botulinum toxin A injection +zinc supplementation" Experimental Treatment 2 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 injection Active Control 1 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.

Botulinum toxin type A is already approved in United States, European Union for the following indications:

Approved in United States as Xeomin for:

• Upper limb spasticity (excluding spasticity caused by cerebral palsy)
• Chronic sialorrhea

Approved in European Union as Xeomin for:

• Upper limb spasticity
• Chronic sialorrhea
• Blepharospasm
• Cervical dystonia

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

IncobotulinumtoxinA (Xeomin) has a longer shelf life and simpler storage requirements compared to traditional botulinum toxin products, indicating that it can remain stable without complexing proteins, which may also reduce the risk of immune reactions.

Clinical studies have demonstrated Xeomin's efficacy in treating conditions like cervical dystonia and blepharospasm, and it has shown a lower incidence of antibody-induced therapy failure, suggesting improved safety and effectiveness over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year experience with incobotulinumtoxinA (Xeomin(®) ): the first botulinum toxin drug free of complexing proteins. Dressler, D.[2022]

Incobotulinumtoxin-A is a cost-effective treatment for blepharospasm and cervical dystonia compared to onabotulinumtoxin-A, with incremental costs per quality-adjusted life-year of A$ 25,588 and A$ 23,794, respectively, based on a 5-year Markov model analysis.

The flexible treatment intervals for incobotulinumtoxin-A allow for better symptom management, resulting in patients experiencing fewer weeks of symptoms compared to the fixed 12-week intervals required for onabotulinumtoxin-A.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Incobotulinumtoxin-A with Flexible Treatment Intervals Compared to Onabotulinumtoxin-A in the Management of Blepharospasm and Cervical Dystonia. Tilden, D., Guarnieri, C.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Correlation between clinical response and injection quality in treatment of spasmodic dysphonia. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Unilateral versus bilateral thyroarytenoid Botulinum toxin injections in adductor spasmodic dysphonia: a prospective study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Longitudinal follow-up of adductor spasmodic dysphonia patients after botulinum toxin injection: quality of life results. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

Quality of Life After Botulinum Toxin Injection in Patients With Adductor Spasmodic Dysphonia; a Systematic Review and Meta-analysis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Combined-modality treatment of adductor spasmodic dysphonia with botulinum toxin and voice therapy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Neurophysiological double-blind trial of a botulinum neurotoxin type a free of complexing proteins. [2014]

7. England pubmed.ncbi.nlm.nih.gov

Five-year experience with incobotulinumtoxinA (Xeomin(®) ): the first botulinum toxin drug free of complexing proteins. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Incobotulinumtoxin-A with Flexible Treatment Intervals Compared to Onabotulinumtoxin-A in the Management of Blepharospasm and Cervical Dystonia. [2018]

9. Austria pubmed.ncbi.nlm.nih.gov

A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin(®)) in cervical dystonia. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

A Quantitative Analysis of OnabotulinumtoxinA, AbobotulinumtoxinA, and IncobotulinumtoxinA: A Randomized, Double-Blind, Prospective Clinical Trial of Comparative Dynamic Strain Reduction. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of botulinum toxin type B (Myobloc) in adductor spasmodic dysphonia. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Onabotulinum toxin A dosage trends over time for adductor spasmodic dysphonia: A 15-year experience. [2022]

13. England pubmed.ncbi.nlm.nih.gov

A single-centre retrospective review of unilateral and bilateral Dysport injections in adductor spasmodic dysphonia. [2010]

14. Norway pubmed.ncbi.nlm.nih.gov

Botulinum toxin treatment for spasmodic dysphonia. [2019]