Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05123053
Status:
RECRUITING
Last Update Posted:
2023-05-26
First Post:
2021-11-05
Brief Title:
Firdapse for Post-BOTOX Vocal Weakness
Sponsor:
Augusta University
Organization:
Augusta University
Study Overview
Official Title:
Amifampridine for the Treatment of Transient Vocal Weakness After OnabotulinumtoxinA Injection for Spasmodic Dysphonia
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Botox injections into the thyroarytenoid muscle are a predictable and effective treatment for SD but typically result in transient symptoms of voice weakness and breathiness during the first 2-3 weeks after injection Investigators hypothesize that voice weakness and breathiness after Botox treatment can be alleviated using amifampridine
Detailed Description:
Spasmodic dysphonia SD is a dystonia which results in vocal breaks The mainstay of treatment involves injections using Botox onabotulinumtoxinA a neuromuscular blocker which inhibits pre-synaptic release of acetylcholine into the neuromuscular junction Botox injections into the thyroarytenoid muscle are a predictable and effective treatment for SD but typically result in transient symptoms of voice weakness and breathiness during the first 2-3 weeks after injection These symptoms can be present for even longer if Botox is over- dosed
Investigators hypothesize that these initial transient symptoms of voice weakness and breathiness after Botox treatment can be alleviated using amifampridine which acts at the neuromuscular junction to increase synaptic presence of the neurotransmitter acetylcholine In these initial studies investigators will look at patients who have significant breathiness following an injection
Investigators hypothesize that these initial transient symptoms of voice weakness and breathiness after Botox treatment can be alleviated using amifampridine which acts at the neuromuscular junction to increase synaptic presence of the neurotransmitter acetylcholine In these initial studies investigators will look at patients who have significant breathiness following an injection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None