Botulism, Iatrogenic Botulism
Conditions
Keywords
botulinum toxin injections, Systemic botulism, neuromuscular transmission, single fiber electromyography, amifampridine
Brief summary
if amifampridine can improve neuromuscular transmission in muscles previously injected with OnabotulinumtoxinA (BTX-A)
Detailed description
Amifampridine may also be effective in treating the sequelae of botulinum toxin injections and this study will determine if neuromuscular transmission as measured by single fiber electromyography is improved in patients treated with BTX-A following administration of amifampridine
Interventions
DRUGAmifampridine
a single dose of amifampridine (20mg) will be orally administered
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
before-after study that will measure neuromuscular jitter before and after administration of amifampridine
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-80 years of either gender and of any racial background * Underwent BTX-A injection of facial muscles including frontalis with a total dose between 100-200 units between 80 and 150 days prior to study * Have decision-making capacity to provide informed consent to study drug dosing and Single Fiber Electromyography (SFEMG)
Exclusion criteria
* History of cardiac arrhythmia * History of seizures or uncontrolled asthma * History of renal or hepatic disease * History of any generalized neuromuscular disease * History of Bell's Palsy or facial nerve trauma * History of treatment with or sensitivity to amifampridine, 3,4 diaminopyridine (DAP) or 4-aminopyridine (Ampyra®) * Currently experiencing sequelae of previous BTX-A treatment * Current use of pyridostigmine (known to alter neuromuscular transmission) * Use of any investigational drug or device within 30 days of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of abnormal pairs | Hour 3 | Wilcoxon's test for paired data will be used to analyze baseline and post-treatment percent abnormal pairs |
| Percentage of Jitter | Hour 3 | Wilcoxon's test for paired data will be used to analyze baseline and post-treatment mean jitter |
| Percentage of pairs that show blocking | Hour 3 | Wilcoxon's test for paired data will be used to analyze baseline and post-treatment percent blocking |
Countries
United States
Outcome results
None listed