CompletedPhase 2

Firdapse for Post-BOTOX Vocal Weakness

United States18 participantsStarted 2021-10-28

Plain-language summary

Botox injections into the thyroarytenoid muscle are a predictable and effective treatment for SD, but typically result in transient symptoms of voice weakness and breathiness during the first 2-3 weeks after injection. Investigators hypothesize that voice weakness and breathiness after Botox treatment can be alleviated using amifampridine.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female ≥18 years of age.
. Capable of providing informed consent.
. Confirmed physician diagnosis of spasmodic dysphonia.
. Receives onabotulinumtoxinA for treatment of their spasmodic dysphonia.
. Experiences significant breathiness ± 5 days following their injection.
. If sexually active and of childbearing potential, willing to use an acceptable method of contraception (as noted below) from screening visit until 3 months after the last dose of investigational product.
. Hormonal contraception (e.g., oral contraceptive, transdermal contraceptive, contraceptive implant, or injectable hormonal contraceptive) for at least 3 months prior to study drug administration, throughout the study, and for 3 months after the last dose of study drug.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Voice Handicap Index-10

Timeframe: over 2 months

Trial details

NCT IDNCT05123053

SponsorAugusta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-27

View on ClinicalTrials.gov More Vocal Weakness(Post-BOTOX Injection) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female ≥18 years of age.
. Capable of providing informed consent.
. Confirmed physician diagnosis of spasmodic dysphonia.
. Receives onabotulinumtoxinA for treatment of their spasmodic dysphonia.
. Experiences significant breathiness ± 5 days following their injection.
. If sexually active and of childbearing potential, willing to use an acceptable method of contraception (as noted below) from screening visit until 3 months after the last dose of investigational product.
. Hormonal contraception (e.g., oral contraceptive, transdermal contraceptive, contraceptive implant, or injectable hormonal contraceptive) for at least 3 months prior to study drug administration, throughout the study, and for 3 months after the last dose of study drug.

Firdapse for Post-BOTOX Vocal Weakness

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Firdapse for Post-BOTOX Vocal Weakness

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria