A Phase 1 interventional study of Amifampridine in Botulism and Iatrogenic Botulism, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Wake Forest University Health Sciences · Phase 1, Interventional, and Treatment
if amifampridine can improve neuromuscular transmission in muscles previously injected with OnabotulinumtoxinA (BTX-A)
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
20 studies on the registry are indexed under Botulism; 3 are open to participants now.
This study's enrollment of 21 is below the median of 29 across 14 interventional studies indexed under Botulism.
Browse Botulism studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Amifampridine
a single dose of amifampridine (20mg) will be orally administered
Also known as: Firdapse
Percentage of abnormal pairs
Wilcoxon's test for paired data will be used to analyze baseline and post-treatment percent abnormal pairs
Time frame: Hour 3
Percentage of Jitter
Wilcoxon's test for paired data will be used to analyze baseline and post-treatment mean jitter
Time frame: Hour 3
Percentage of pairs that show blocking
Wilcoxon's test for paired data will be used to analyze baseline and post-treatment percent blocking
Time frame: Hour 3
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2023 to primary completion in Oct 2024, 13 months.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amifampridine
Wake Forest University Health Sciences →