New drug may quiet the hoarseness after botox for voice spasms
NCT ID NCT05123053
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether amifampridine can reduce temporary voice weakness and breathiness that often occurs in the first few weeks after Botox injections for spasmodic dysphonia (a voice disorder). 18 adults who regularly get Botox for this condition took part. The goal was to see if the drug could ease these short-term side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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18 people
The number who actually took part.
- Started
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Oct 2021
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 6. 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. A.NOTE: No adequate clinical data on exposed pregnancies are available for amifampridine. No nonclinical safety data are available regarding the effects of amifampridine on reproductive function. Amifampridine phosphate should not be used during pregnancy. It is unknown whether amifampridine is excreted in human breast milk. The excretion of amifampridine in milk has not been studied in animals. Amifampridine phosphate should not be used during breastfeeding. Acceptable methods of birth control include: 1. 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. 2. 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. 3. Intrauterine contraception/device starting at the Screening visit, throughout the study, and for 3 months after the last dose of study drug. 4. Total abstinence from sexual intercourse (only acceptable if it is the preferred and usual lifestyle of the subject) for at least 1 complete menstrual cycle prior to the Screening visit, throughout the study, and for 3 months after the last dose of study drug. 5. Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy. B. NOTE: Periodic abstinence (calendar, symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Exclusion Criteria: 1. 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: 1. anaesthetic drugs (propofol), 2. antibiotics (penicillins, cephalosporins, imipenem), 3. some antidepressants (clomipramine, bupropion, and maprotiline), 4. antipsychotics (clozapine, chlorpromazine), 5. bronchodilators (aminophylline, theophylline), 6. Immunomodifiers (cyclosporine), and 7. Narcotic analgesics (pethidine, fentanyl). 2. Any SGOT, SGPT that are more than 3x upper limit of normal; and, creatinine that is greater than 2.1 3. Women who are pregnant, expecting to get pregnant, or breastfeeding. 4. Any condition that, in the view of the Principal Investigator, places the subject at risk, or subjects with poor treatment compliance.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Augusta University
Augusta, Georgia, 30912, United States