Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Amifampridine

Criteria

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