A Proof of Concept Study of the Effect of Amifampridine (Firdapse®) on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA (Botox®, BTX-A)

IRB00091315

if amifampridine can improve neuromuscular transmission in muscles previously injected with OnabotulinumtoxinA (BTX-A)

2023-09-15

2024-06-01

2024-06-01

Recruiting

Early phase I

20

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'before-after study that will measure neuromuscular jitter before and after administration of amifampridine', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-03-04