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Potassium Channel Blocker
Amifampridine for Botulism
Phase 1
Recruiting
Led By James B Caress, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hour 3
Awards & highlights
Study Summary
This trial tested if a drug could improve muscle control in people who had a type of botox injection.
Who is the study for?
This trial is for adults aged 18-80 who have had Botox injections in facial muscles and are now looking to improve muscle function. They must be able to consent, not have a history of heart rhythm problems, seizures, severe asthma, liver or kidney disease, facial nerve issues, or use of investigational drugs recently.Check my eligibility
What is being tested?
The study tests if amifampridine can enhance muscle response in patients previously treated with Botox. Participants will receive the drug and undergo specialized muscle testing to measure any improvements in neuromuscular transmission.See study design
What are the potential side effects?
Amifampridine may cause side effects such as tingling sensations, sleep disturbances, digestive discomforts like diarrhea or stomach pain. It's also known for potentially causing seizures in some individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ hour 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hour 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Jitter
Percentage of abnormal pairs
Percentage of pairs that show blocking
Side effects data
From 2020 Phase 3 trial • 93 Patients • NCT0330405443%
Paraesthesia oral
40%
Paraesthesia
16%
Nausea
14%
Diarrhoea
13%
Headache
12%
Fatigue
10%
Hypoaesthesia oral
9%
Dizziness
8%
Abdominal pain upper
8%
Dyspepsia
6%
Muscle spasms
6%
Peripheral coldness
6%
Abdominal discomfort
5%
Pain in extremity
5%
Hypoaesthesia
3%
Urinary tract infection
3%
Sensory disturbance
3%
Feeling cold
3%
Vomiting
3%
Asthenia
3%
Nasopharyngitis
3%
Abdominal pain
3%
Back pain
3%
Tinnitus
3%
Dyspnoea
3%
Oropharyngeal pain
2%
Palpitations
2%
Anxiety
2%
Rash maculo-papular
2%
Feeling hot
2%
Ear infection
2%
Sinusitis
2%
Diplopia
2%
Fall
2%
Muscular weakness
2%
Speech disorder
2%
Insomnia
2%
Cough
1%
Myasthenia gravis
1%
Myasthenia gravis crisis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Amifampridine Phosphate
Placebo
Overall
Trial Design
1Treatment groups
Experimental Treatment
Group I: Amifampridine will be orally administered to study participantsExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,247 Total Patients Enrolled
James B Caress, MDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can make my own decisions and agree to study treatments and tests.I am currently taking pyridostigmine.I have a history of irregular heartbeats.I have a history of seizures or my asthma is not under control.I have had Bell's Palsy or injury to my facial nerve.I am between 18 and 80 years old.I have a history of kidney or liver disease.I am experiencing side effects from previous Botox treatments.I haven't used any experimental drugs or devices in the last 30 days.I received a Botox injection in my face with 100-200 units, 80-150 days ago.I have had or am sensitive to treatments with amifampridine or similar drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Amifampridine will be orally administered to study participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you offer information about the hazards of oral Amifampridine for study participants?
"Our team at Power rated Amifampridine's safety a 1, as the medication is still in its early stages of clinical trials and has not yet been properly assessed for efficacy."
Answered by AI
Would I meet the qualifications to join this medical study?
"Eligibility for this clinical trial necessitates a botulism diagnosis and being between the ages of 18-80. In total, 20 people will be accepted into this research project."
Answered by AI
Is the age range for this clinical trial including individuals under 45?
"To be accepted into this clinical trial, individuals must fall between the age groups of 18 to 80 years old. Notably, there are two separate studies for those below and above these given ages."
Answered by AI
Is enrollment still available for the experiment?
"According to clinicaltrials.gov, the recruitment process for this study has been concluded; it was posted on April 1st 2023 and last updated March 3rd 2023. Thankfully, there are currently two other trials accepting participants at this time."
Answered by AI
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