RecruitingPhase 2Phase 3NCT03701581

4-aminopyridine Treatment for Nerve Injury

4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy


Sponsor

John Elfar

Enrollment

70 participants

Start Date

Jun 5, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a drug called 4-aminopyridine (4-AP), which helps injured nerves recover, can help men regain erectile function after prostate cancer surgery that is intended to preserve the nerves controlling erections (nerve-sparing radical prostatectomy). **You may be eligible if...** - You are a man between 45 and 75 years old - You have been diagnosed with early-stage prostate cancer (stages T1c to T2c) that has not spread - You are scheduled to have robot-assisted nerve-sparing radical prostatectomy - Your PSA level is less than 15 ng/mL - You have had regular sexual activity and normal erectile function (IIEF-5 score of 17 or higher) in the past 3 months - You are willing to avoid other erectile dysfunction treatments for 3 months after surgery **You may NOT be eligible if...** - You have advanced prostate cancer (stage T3 or above) or cancer that has spread to lymph nodes - You need additional treatment (radiation or hormone therapy) after surgery - You have a history of seizures, multiple sclerosis, stroke, or other neurological disorders - You have kidney problems (GFR below 60 mL/min) - You are allergic to 4-aminopyridine - You have had penile surgery (other than circumcision) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG4-Aminopyridine

FDA-approved tablets.

OTHERPlacebo

Placebo will be tooled to look similar to the study drug.


Locations(2)

University of Arizona

Tucson, Arizona, United States

University of Rochester

Rochester, New York, United States

View Full Details on ClinicalTrials.gov

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NCT03701581


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