Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2024-10-29

Brief Summary

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

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Detailed Description

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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

Conditions

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Botulism Iatrogenic Botulism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

before-after study that will measure neuromuscular jitter before and after administration of amifampridine

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amifampridine will be orally administered to study participants

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.

Group Type EXPERIMENTAL

Amifampridine

Intervention Type DRUG

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

Interventions

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Amifampridine

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

Intervention Type DRUG

Other Intervention Names

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Firdapse

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No