NCT07832331尚未招募1 期
Single Dose 4-Aminopyridine for Diagnosing Recurrent Laryngeal Nerve Paralysis Continuity After Trauma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Number of subjects with vocal cord paralysis after receiving 4-aminopyridine
研究概览
简要总结
This study aims to evaluate the role of single-dose 4-aminopyridine on the diagnosis of recurrent laryngeal nerve (RLN) paralysis. In addition, the investigational treatment will be used to test the hypothesis that 4-aminopyridine can speed the determination of nerve continuity after RLN injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent Laryngeal Nerve injury (including acute unilateral, and bilateral vocal cord paralysis) following trauma, surgery or intubation
- •Closed soft tissue envelope obscuring direct observation of the continuity of the affected nerve
- •Cognitive ability to report sensory and motor deficit during examination
- •Able to complete single day dosing within 4 months of the inciting event
- •Eligible for standard of care plan of monitoring
- •Adults subject aged 18+
- •Availability for main trial day within 1 week of diagnosis and follow-up visits as needed
排除标准
- •History of multiple sclerosis, stroke or any other diagnosed neurological or central nervous system disorder or injury
- •History of intercranial surgery
- •History of hypersensitivity to AMPYRA® or 4-aminopyridine
- •Current use of aminopyridine medications, including other compounded 4-AP, e.g. fampridine, dalfampridine
- •Patients with known history of renal impairment (calculated GFR (GFR<80 mL/min)) within 6 months time
- •Patients with a known history of a seizure disorder (4-AP overdose can, in selected cases, result in limited seizure activity).
- •Patients unable to communicate return or loss of sensation.
- •Patients with injuries too extensive to isolate a single nerve(s) for testing.
- •Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, e.g. Cimetidine, dolutegravir, isavuconazole, ranolazine.
- •Patients who had a direct transection or sacrifice of the nerve
- •Patients who are pregnant
- •History of direct laryngeal trauma
- •Intolerance of exam or study procedures
- •Inability to visualize the larynx upon scope exam
- •Procedural or other pharmacological treatments of RLN paralysis prior to enrollment
研究组 & 干预措施
4-Aminopyridine Dose
Experimental
Subjects will receive one dose of oral 4-aminopyridine 10 mg extended release tablet at start of study day prior to initial flexible laryngoscopy exam.
干预措施: 4-Aminopyridine (Drug)
结局指标
主要结局
Number of subjects with vocal cord paralysis after receiving 4-aminopyridine
时间窗: 3 hours
Evaluate for improvement in vocal cord motion as assessed by an otolaryngologist via repeat flexible laryngoscopy after 3 hours from receiving 4-aminopyridine.
次要结局
- Change in Voice Handicap Index score after receiving 4-aminopyridine(baseline to 3 hours)
- Change in Eating Assessment Tool-10 score after receiving 4-aminopyridine(baseline to 3 hours)
- Change in Reflux Symptom Index score after receiving 4-aminopyridine(baseline to 3 hours)
研究者
John Gniady
Associate Professor of Otolaryngology
Milton S. Hershey Medical Center
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