Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA (NCT05769478) | Clinical Trial Compass
CompletedPhase 1
Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA
United States21 participantsStarted 2023-09-15
Plain-language summary
if amifampridine can improve neuromuscular transmission in muscles previously injected with OnabotulinumtoxinA (BTX-A)
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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