Firdapse for Post-BOTOX Vocal Weakness

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Augusta University
• Treatments: Amifampridine

Criteria

Inclusion Criteria:

1. Male or female ≥18 years of age.

2. Capable of providing informed consent.

3. Confirmed physician diagnosis of spasmodic dysphonia.

4. Receives onabotulinumtoxinA for treatment of their spasmodic dysphonia.

5. Experiences significant breathiness ± 5 days following their injection.

Exclusion Criteria:

1. History of epilepsy and on medication/treatment for the same.

2. Women who are pregnant, expecting to get pregnant, or breastfeeding.

3. Any condition that, in the view of the Principal Investigator, places the subject at risk, or subjects with poor treatment compliance.