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Firdapse for Post-BOTOX Vocal Weakness
Phase 2
Recruiting
Led By Michael H Rivner, MD
Research Sponsored by Augusta University
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 over 2 months
Awards & highlights
Study Summary
This trial is testing whether a medication can alleviate symptoms of voice weakness and breathiness after Botox treatment for a vocal cord condition.
Who is the study for?
This trial is for adults over 18 with spasmodic dysphonia who experience voice weakness after Botox treatment. Participants must be able to consent, use contraception if of childbearing potential, and not have certain liver or kidney issues, a risk-prone condition as per the investigator's view, poor treatment compliance, pregnancy/breastfeeding status, or a history of epilepsy.Check my eligibility
What is being tested?
The study tests whether amifampridine can reduce symptoms of voice weakness and breathiness in patients with vocal cord muscle injections post-Botox treatment for spasmodic dysphonia. It aims to improve the transient side effects that occur during the first few weeks after injection.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to amifampridine which could include signs similar to those seen in other medications affecting nerve-muscle communication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Voice Handicap Index-10
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: Treatment ArmExperimental Treatment1 Intervention
subjects will be given active drug and titrated up in 10mg increments (with max single dose being 30mg) until a change or drug side effect is noticed.
Find a Location
Who is running the clinical trial?
Augusta UniversityLead Sponsor
211 Previous Clinical Trials
85,058 Total Patients Enrolled
Michael H Rivner, MDPrincipal InvestigatorCharbonnier Professor Emeritus of Neurology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking medications that can increase the risk of having seizures.A doctor has diagnosed you with spasmodic dysphonia.You are currently receiving onabotulinumtoxinA for your spasmodic dysphonia treatment.You have severe difficulty breathing within 5 days after receiving the injection.You have a history of epilepsy or are currently taking medication or receiving treatment for seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Has Amifampridine undergone testing by the Food and Drug Administration?
"Amifampridine is classified as a Phase 2 drug, meaning that while there is evidence of safety, there is no clinical data yet supporting its efficacy."
Answered by AI
Is Amifampridine a common medication in clinical trials?
"Amifampridine is being studied in 1 clinical trial at the moment. However, of those trials, none have reached Phase 3 yet. Most of the research is taking place in Augusta, Georgia; though, there is at least one other location running a trial for this medication."
Answered by AI
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