Firdapse for Post-BOTOX Vocal Weakness (NCT05123053) | Clinical Trial Compass
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 range18 Years
SexALL
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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.
✓. Double-barrier birth control (e.g., a combination of male condom with either cap, diaphragm, or sponge together with spermicide) starting at the Screening visit, throughout the study, and for at least 4 weeks after the last dose of study drug. NOTE: Use of a male and female condom simultaneously is NOT an acceptable method of double-barrier birth control.
Exclusion criteria
✕. History of epilepsy and/or on medication/treatment for seizures (such as but not limited to valproic acid, lamotrigine, topiramate, carbamazepine, and phenytoin); or, on certain medications that may lower seizure threshold, such as: