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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding zinc supplements can extend the effects of Botox for individuals with spasmodic dysphonia, a voice disorder that makes speaking difficult. Researchers aim to determine if taking zinc before Botox injections prolongs relief from voice spasms. Participants will receive either Botox with zinc or just Botox, the standard treatment. Suitable candidates are adults who have received Botox injections for spasmodic dysphonia for over six months and do not consume more than 30 mg of zinc supplements daily. As a Phase 1, Phase 2 trial, this research seeks to understand the treatment's mechanism in people and measure its effectiveness in an initial, smaller group.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Botulinum toxin type A (BT) is generally safe and well-tolerated for various conditions, including spasmodic dysphonia. It has a good safety record, indicating it is safe for most people when used correctly. Although some side effects can occur, they are rare and usually minor, such as temporary muscle weakness.

Specific information about using zinc supplements with BT for spasmodic dysphonia is limited. However, zinc is a common dietary supplement, and most people tolerate it well. In some cases, high doses can cause nausea or an upset stomach, but this is uncommon.

This trial is in the early stages, meaning the study is still gathering safety information for this specific treatment combination. However, the FDA has already approved BT for other uses, providing some confidence in its overall safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the combination of zinc and Botox for treating spasmodic dysphonia because it offers a potentially enhanced approach compared to the standard Botox treatment alone. Most treatments for this condition, like Botulinum toxin type A injections, focus solely on relaxing the vocal cords to reduce spasms. However, the addition of zinc gluconate supplementation may boost the effectiveness of Botox by enhancing its uptake and duration of action. This could lead to longer-lasting relief for patients and possibly reduce the frequency of injections needed, potentially improving the overall treatment experience.

What evidence suggests that this trial's treatments could be effective for spasmodic dysphonia?

Research has shown that botulinum toxin injections can improve voice issues in people with spasmodic dysphonia. In this trial, one group of participants will receive only botulinum toxin injections, the current standard of care. Another group will receive botulinum toxin injections combined with zinc supplementation. An early study found that adding zinc supplements to the treatment might extend the benefits. This effect was first observed in facial treatments, where zinc appeared to prolong the effects of botulinum toxin. Zinc influences how botulinum toxin works, which might explain the varied responses to the treatment. Overall, this combination could provide longer-lasting relief for those with spasmodic dysphonia. ^{6 7 8 9 10}

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

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9825114/

Use of Botulinum Toxin in Spasmodic Dysphonia: A Review of ... While btx injections may show vocal improvement in both types of SD, results can depend on several factors such as the general health of the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8805439/

Botulinum toxin injections for the treatment of spasmodic ... The results of this review of randomized controlled trials indicate that botulinum toxin is effective for some aspects of voice production.

3. withpower.com withpower.com/trial/phase-2-dysphonia-6-2023-904fe

Zinc + Botox for Spasmodic Dysphonia · Info for Participants One initial study has shown that Botulinum Toxin (BT) in combination with zinc supplementation may increase the duration of effects BT treatment.

4. researchgate.net researchgate.net/publication/397138624_Zinc-dependent_modulation_of_botulinum_toxin_type_A_efficacy_strategies_for_overcoming_variability_in_therapeutic_response_in_injection_cosmetology

Zinc-dependent modulation of botulinum toxin type A efficacy This article systematizes data on the molecular mechanisms of zinc dependence of botulinum toxin type ... Spasmodic dysphonia (DS) is a disabling ...

5. mdpi.com mdpi.com/2072-6651/8/3/65

Conversion Ratio between Botox®, Dysport®, and Xeomin ... Botulinum neurotoxin injections are a valuable treatment for many therapeutic indications and have revolutionized the treatment of spasticity and dystonia.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05892770

Zinc Supplementation Prior to Botox Injections for ... 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 ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/125360s073lbl.pdf

Xeomin - accessdata.fda.gov Postmarketing safety data from XEOMIN and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases,b e observed beyond the site ...

8. go.drugbank.com go.drugbank.com/drugs/DB00083

Botulinum toxin type A: Uses, Interactions, Mechanism of ... With a wide variety of applications and favourable safety profile, Botulinum toxin A injection is a minimally invasive and promising treatment for cosmetic ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36628391/

Use of Botulinum Toxin in Spasmodic Dysphonia While btx injections may show vocal improvement in both types of SD, results can depend on several factors such as the general health of the patient.

10. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33274

LCD - Botulinum Toxins (L33274) Studies show botulinum neurotoxin should be recommended as a treatment option for adductor spasmodic dysphonia (ADSD); however, there is inadequate evidence to ...