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4-aminopyridine Treatment for Nerve Injury

RecruitingPhase 2/3

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

Who can join

Ages 45 to 75 · Men

Full eligibility criteria
Inclusion Criteria

* Male patients with organ-confined, non-metastatic prostate cancer (stages cT1c-T2c), planning to undergo Robotic-Assisted Laparoscopic Bilateral Nerve Sparing Radical Prostatectomy (NSRP)
* Prostate-Specific Antigen (PSA) levels less than 15 ng/ml (within the last 12 months), with biopsy-proven prostate cancer, for whom postoperative adjuvant therapy (e.g. radiation or androgen deprivation therapy) is not expected to be needed
* Ages 45-75
* An Abridged International Index of Erectile Function-Erectile Function (IIEF-5) score of greater than or equal to 17 at time of screening
* Has experienced at least 6 months of regular sexual activity and sexual activity during the 12 weeks prior to prostate biopsy or surgery
* Willingness to abstain from treatments for Erectile Dysfunction until 3 months after surgery
* Willingness to participate and able to provide informed consent

Exclusion Criteria

* Planned adjuvant therapy after NSRP based on specimen pathology and stage of prostate cancer (stage T3 or greater), positive lymph nodes or positive surgical margins
* Neo-adjuvant therapy prior to NSRP
* History of recurrent prostate cancer
* History of seizures, multiple sclerosis, stroke or any other diagnosed neurological disorder
* History of non-organ confined or metastatic prostate cancer (clinical Stages T3 or greater)
* History of known hypersensitivity to 4AP
* Patients with history of penile surgery other than circumcision or endoscopic urethral stricture surgery
* Renal impairment based on calculated GFR (GFR\<60 mL/min)
* Use of any other aminopyridine medications for any other indication

About the study

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.

What is being tested

Sponsor: John Elfar · Participants: 70 · Started: Jun 5, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT03701581

Locations in the U.S.

ArizonaUniversity of Arizona, Tucson

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.