4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Placebo vs. Active Drug Questionnaire
研究概览
简要总结
To evaluate the role of 4-aminopyridine (4-AP) on the course of recovery after peripheral nerve traction and/or crush injury. This study aims to test the hypothesis that 4-aminopyridine speeds the often slow and unpredictable recovery after peripheral nerve traction and/or crush injuries.
详细描述
To evaluate the role of 4-AP on the recovery of nerve function we will be giving patients with prostate cancer who are undergoing robot assisted radical prostatectomy (RP) either 4-AP or placebo in the perioperative period. This population of patients was selected as nerve crush injury during RP is thought to contribute to erectile dysfunction and urinary continence post operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A: Investigational Treatment
- FDA-approved 10mg dalfampridine (generic Ampyra)
- Subjects will not take more than 2 tablets in a 24-hour period
- Subjects will take the tablets whole. They will not break, crush, chew, or dissolve tablets before swallowing.
- The subjects will be told that the medication is released slowly over time and if the tablet is broken, the medicine may be released too fast which can raise the chance of having a seizure.
- Study drug can be taken with or without food.
- If a dose is missed they should not make up the missed dose. They will be told not to take two doses at the same time but to take the next dose at the regular scheduled time.
- Subjects will be reminded not to take study drug together with other aminopyridine medications, including compounded 4-AP (sometimes called 4-aminopyridine or fampridine).
干预措施: 4-Aminopyridine (Drug)
Group B: Placebo
Subjects will receive an oral dose of placebo treatment the day after surgery, continuing daily for 2 months (60 days) following the same administration instructions as the investigational treatment. The placebo tablets will be manufactured by a licensed compounding pharmacy. The Investigational Drug Service at Banner University Medical Center will manage the placebos.
干预措施: Placebo (Other)
结局指标
主要结局
Placebo vs. Active Drug Questionnaire
时间窗: through study completion, an average of 1 year
Specific questions regarding patient blinding
Michigan Incontinence Sympton Index (M-ISI) (change over time)
时间窗: Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).
Incontinence measurement (change over time)
International Index of Erectile Function (IIEF) (change over time)
时间窗: Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).
Erectile function measurement tool. (change over time)
次要结局
- Drug Diary(Daily for 90 days.)
- Attempted Sexual Activity Questionnaire(Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).)
研究者
John Elfar
Tenured Professor, Chairman, Department of Orthopaedic Surgery
University of Arizona