NCT03701581RecruitingPhase 2/3
4-aminopyridine Treatment for Nerve Injury
4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 25 Oct 2017
- Start date
- 5 Jun 2021
- Primary completion date
- Jul 2027
- Lead sponsor
- John Elfar
- Diseases
- Prostate cancer
- NCT number
- NCT03701581
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 70
- From 5 Jun 2021 to the primary completion date, Jul 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Neo-adjuvant therapy prior to NSRP
- Use of any other aminopyridine medications for any other indication
Other illness
- 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
- 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
Lab values
- Renal impairment based on calculated GFR (GFR\<60 mL/min)
Who the study is looking for
- 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
Age in the registry: 45 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Terminated |
| University of Arizona Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.