Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA

Botulism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05769478
• Other study ID #: IRB00091315
• Status: Recruiting
• Phase: Phase 1
• Start date: September 15, 2023
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: Katherinne S Velasquez
• Phone: 336.716.6031
• Email: kserrano[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Botulism

Intervention

Drug:
• Amifampridine
a single dose of amifampridine (20mg) will be orally administered

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of abnormal pairs	Wilcoxon's test for paired data will be used to analyze baseline and post-treatment percent abnormal pairs	Hour 3
Primary	Percentage of Jitter	Wilcoxon's test for paired data will be used to analyze baseline and post-treatment mean jitter	Hour 3
Primary	Percentage of pairs that show blocking	Wilcoxon's test for paired data will be used to analyze baseline and post-treatment percent blocking	Hour 3