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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
- 4-Aminopyridine (drug)
- Placebo (other)
Sponsor: John Elfar · Participants: 70 · Started: Jun 5, 2021
Contact the study team
- Andrea Horne · Phone: 520-626-6456
Official record on ClinicalTrials.gov — NCT03701581
Locations in the U.S.
| Arizona | University 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.