Actively Recruiting

Phase 2
Phase 3
Age: 45Years - 75Years
MALE
NCT03701581

4-aminopyridine Treatment for Nerve Injury

Led by John Elfar · Updated on 2025-12-17

70

Participants Needed

2

Research Sites

390 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

4-aminopyridine Treatment for Nerve Injury

Who Can Participate

Age: 45Years - 75Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients with organ-confined, non-metastatic prostate cancer (stages cT1c-T2c) planning to undergo Robotic-Assisted Laparoscopic Bilateral Nerve Sparing Radical Prostatectomy
  • Prostate-Specific Antigen (PSA) levels less than 15 ng/ml within the last 12 months
  • Biopsy-proven prostate cancer with no expected need for postoperative adjuvant therapy
  • Aged 45 to 75 years
  • Abridged International Index of Erectile Function-Erectile Function (IIEF-5) score of 17 or higher at screening
  • At least 6 months of regular sexual activity and sexual activity during the 12 weeks prior to prostate biopsy or surgery
  • Willing to abstain from erectile dysfunction treatments until 3 months after surgery
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Planned adjuvant therapy after surgery based on pathology or cancer stage (stage T3 or greater), positive lymph nodes, or positive surgical margins
  • Neo-adjuvant therapy prior to surgery
  • History of recurrent prostate cancer
  • History of seizures, multiple sclerosis, stroke, or other neurological disorders
  • History of non-organ confined or metastatic prostate cancer (clinical stage T3 or greater)
  • Known hypersensitivity to 4-aminopyridine
  • History of penile surgery other than circumcision or endoscopic urethral stricture surgery
  • Renal impairment with calculated GFR below 60 mL/min
  • Use of any other aminopyridine medications for any indication

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Arizona

Tucson, Arizona, United States, 85724

Actively Recruiting

2

University of Rochester

Rochester, New York, United States, 14602

Terminated

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Research Team

A

Andrea Horne

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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