Firdapse for Post-BOTOX Vocal Weakness

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    10
  • sponsor
    Augusta University
Updated on 25 November 2021

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. We hypothesize that voice weakness and breathiness after Botox treatment can be alleviated using amifampridine.

Description

Spasmodic dysphonia (SD) is a dystonia which results in vocal breaks. The mainstay of treatment involves injections using Botox (onabotulinumtoxinA), a neuromuscular blocker which inhibits pre-synaptic release of acetylcholine into the neuromuscular junction. 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. These symptoms can be present for even longer if Botox is overdosed.

We hypothesize that these initial, transient symptoms of voice weakness and breathiness after Botox treatment can be alleviated using amifampridine which acts at the neuromuscular junction to increase synaptic presence of the neurotransmitter acetylcholine. In these initial studies we will look at patients who have significant breathiness following an injection.

Details
Condition Post-BOTOX Vocal Weakness
Treatment Amifampridine, Amifampridine
Clinical Study IdentifierNCT05123053
SponsorAugusta University
Last Modified on25 November 2021

Eligibility

Yes No Not Sure

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

Exclusion Criteria

History of epilepsy and on medication/treatment for the same
Women who are pregnant, expecting to get pregnant, or breastfeeding
Any condition that, in the view of the Principal Investigator, places the subject at risk, or subjects with poor treatment compliance
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note