Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA

Wake Forest University (WFU)

Status and phase: Completed; Phase 1

Conditions: Botulism; Iatrogenic Botulism

Treatments: Drug: Amifampridine

Study type: Interventional

Funder types: Other

Identifiers

NCT05769478

IRB00091315

Details and patient eligibility

About

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

Full 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

Enrollment: 21 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

21 participants in 1 patient group

Amifampridine will be orally administered to study participants

Experimental group

Description:

Amifampridine will be orally administered to study participants following completion of the baseline SFEMG. Post-dose SFEMG will commence at 30 minutes following dosing and will be completed within 30 minutes. The participant will remain under observation in the Diagnostic Neurology suite for 2 hours after dosing so it is estimated that the entire protocol including monitoring will be completed within 2-3 hours.

Treatment:

Drug: Amifampridine