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Completed

NCT Number: NCT05769478

Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA

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

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Key information

Conditions

Botulism Bacterial Infections Bacterial Infections and Mycoses Chemically-Induced Disorders Clostridium Infections Foodborne Diseases Gram-Positive Bacterial Infections Iatrogenic Botulism Infections Nervous System Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Neurotoxicity Syndromes Poisoning

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amifampridine

Drug

a single dose of amifampridine (20mg) will be orally administered

Other names: Firdapse

Primary outcomes

  1. Percentage of abnormal pairs

    Time frame: Hour 3

    Wilcoxon's test for paired data will be used to analyze baseline and post-treatment percent abnormal pairs

  2. Percentage of Jitter

    Time frame: Hour 3

    Wilcoxon's test for paired data will be used to analyze baseline and post-treatment mean jitter

  3. Percentage of pairs that show blocking

    Time frame: Hour 3

    Wilcoxon's test for paired data will be used to analyze baseline and post-treatment percent blocking

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2023
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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