RECRUITING

Firdapse for Post-BOTOX Vocal Weakness

Conditions

Vocal Weakness(Post-BOTOX Injection)BOTOX Onabotulinumtoxin Spasmodic Dysphonia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Amifampridine for the Treatment of Transient Vocal Weakness After OnabotulinumtoxinA Injection for Spasmodic Dysphonia

Quick Facts

Study Start:2021-10-28

Study Completion:2023-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05123053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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.	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.

Inclusion Criteria

Exclusion 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.
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.

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.

Contacts and Locations

Study Contact

Brandy Quarles, MPH

CONTACT

706-721-0390

bquarles@augusta.edu

Kristy Bouchard, BS

CONTACT

706-721-0390

kbouchard@augusta.edu

Principal Investigator

Michael H Rivner, MD

PRINCIPAL_INVESTIGATOR

Charbonnier Professor Emeritus of Neurology

Study Locations (Sites)

Augusta University

Augusta, Georgia, 30912

United States

Collaborators and Investigators

Sponsor: Augusta University

Michael H Rivner, MD, PRINCIPAL_INVESTIGATOR, Charbonnier Professor Emeritus of Neurology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-28

Study Completion Date2023-12-30

Study Record Updates

Study Start Date2021-10-28

Study Completion Date2023-12-30

Terms related to this study

Keywords Provided by Researchers

BOTOX
Onabotulinumtoxin
Spasmodic Dysphonia

Additional Relevant MeSH Terms

Vocal Weakness(Post-BOTOX Injection)